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Date Job Title Job Level Location
5/27/18 Lead PHC 2.0, Office of I2O Innovation Individual contributor South San Francisco, California

Roche Pharmaceuticals is focused on translating excellence in science into effective medicines for patients. It combines cutting-edge research at Roche, Genentech in the US, and over 150 partners worldwide with global scale and reach in clinical development, manufacturing and commercial operations.

Focusing on immunology, ophthalmology, infectious diseases, oncology, and neuroscience, we firmly believe in the tremendous potential to translate science into therapies which reduce human suffering and help people live longer and healthier lives.
Roche is looking for novel and innovative pathways for expanding drug development opportunities across the portfolio, with an aim to address unmet patient need.
With our innovative products and impressive pipeline, we can offer a depth and breadth of opportunities for forward thinking, entrepreneurial and innovative individuals.

The Role:

The Lead PHC 2.0, Office of I2O Innovation in Product Development, I2O will identify and lead innovative strategies to create personalized healthcare (PHC) 2.0 for I2O.

As a strategic thinker and a broadly experienced expert in clinical drug development with excellent scientific and communication credentials, you will lead activities to develop and implement the strategy for PHC 2.0 in I2O, by building the vision and establishing collaborations within Roche and with relevant external groups, including academic centers, health authorities, businesses, government institutions and other partners. As the PHC 2.0 lead for I2O within Roche, you will mobilize the organization behind your vision and strategy, including cross-functional and cross-organizational leadership to enable the next steps for PHC 2.0 in I2O. PHC 2.0 in I2O will allow Roche to realize the potential of novel and/or big data sources; through the establishment of analytical methods to assist in the identification and evaluation of new imaging and/or genetic biomarkers and therapies to treat high unmet need disease within the I2O space.

As a core member of the Office of I2O Innovation team you will take accountability for leading cross-functional engagement to achieve the following ambitious goals for PHC 2.0, specifically:

  • Establish and build upon cross-functional and cross-organizational networks, to identify opportunities to build coalitions to move the vision forward.
  • Utilize your depth of experience, to identify creative and successful paths to achieve this vision, including a discerning approach about when to partner with others across the organization vs. identify and engage expertise that may be needed from external sources.
  • Lead cross-organizational efforts and/or external expert collaborations utilizing an approach of working through others to bring out the talents of others achieve ambitious goals.
  • Work closely with internal stakeholders (including the joint PHC center of excellence, research & early development, biometrics, RWD and strategic innovation) and external stakeholders in leveraging an accessible and comprehensive integrated databases (e.g. genomic, biomarker, clinical and imaging data)
  • Partner with analytics experts to implement novel accessible analytical methods, e.g. machine learning, for large-scale data mining, with the ultimate goal of identifying new imaging and/or genetic biomarkers and new disease targets to advance product development
  • Evaluate the potential for novel sources of data to contribute to evidence generation throughout research and development, with potential applications for internal decision-making as well as generating high quality scientific evidence ?
  • Bring a global mindset to all projects with energy and enthusiasm to see the project moves forward.

Additional Responsibilities:

  • Critical evaluation of potential strategic innovation proposals including molecular based strategies for future drug development, with a strong emphasis on clinical and scientific aspects.
  • Contribute to the identification and delivery of the best collaborative opportunities with the various Roche functions (including the Roche PHC 2.0 Center of Excellence) as well as external opportunities with academic groups, non-profit research organizations, biotech/pharma and technology companies.
  • Develop and maintain a strong collaboration structure custom-made to the particular collaboration (e.g., Lifecycle Teams)
  • Best represent Roche’s scientific excellence and high ethical standards when interacting with potential outside partners
  • Serve as a role model within Roche in developing a vibrant, entrepreneurial, environment supporting courageous leadership, innovation and collaboration.
  • Promote a culture of scientific innovation and continuous improvement.
  • May manage teams in the delivery of program or collaboration objectives

Minimum Requirements:

  • Advanced degree in a scientific discipline with good understanding of quantitative methods(e.g. biostatistics, bioinformatics, computational biology, etc). Individuals with a bachelors degree in a scientific discipline and significant industry experience (> 10 years) will be considered.
  • A proven leader with extensive experience in clinical/drug development in the biotechnology/pharmaceutical industry/academia, and excellent understanding of drug development regulations
  • Demonstrated results-focus and ability to deliver projects through lateral influence, relationship management, negotiation and facilitation
  • Demonstrated critical thinking and communication skills, to help identify the best innovative options to bring forward into pilot and experimentation as well as conduct thoughtful assessment of the learnings from the pilots.
  • Ability to integrate/translate abstract concepts into tangible, results oriented plans to allow for early application and learning as well as rapid iteration to build upon the experience
  • Ability to deal successfully with ambiguity and persevere through multiple experiments with a focus on learnings as well as outcomes
  • Strong peer networks within Roche, the pharmaceutical industry and/or academia is a plus
  • Ability to identify and secure needed expertise to drive a project forward in a scientifically robust manner
  • Highly organized, with the ability to work to tight timelines when needed and high level of budget accountability
  • Excellent organizational and communication (both written and verbal) skills
  • Management and cross-functional leadership experience strongly preferred
  • Demonstrated track record as an innovator in the pharmaceutical industry or in a similar large organization strongly preferred
  • People focus with openness to providing mentorship to others, including potential rotation candidates and fellowsWillingness and ability to travel
  • Additional attributes sought:
  • Clinical development experience and judgment
  • At the forefront of a changing and competitive environment
  • Creative and innovative mindset
  • Lives Roche values of courage, passion, integrity
  • Commitment to I2O and Roche strategy
  • Ability to partner/work in a matrixed organization with cross-functional partners
  • Has worked at a premier company or academic institution with primary focus in a therapeutic area in I2O

5/27/18 Associate Director, Physical Safety Executive (Director/VP) South San Francisco, California

The Associate Director of Physical Safety has direct accountability for leading all aspects of Genentech's physical safety programs and associated compliance assurance activities at the South San Francisco (SSF) and Dixon sites.  This position will work closely with Genentech’s senior leadership teams to develop, align, and implement strategic goals to maintain EHS compliance and promote an effective EHS culture. This position manages a team of safety professionals, reports to the EHS Director and serves as a member of the EHS leadership team.

The ideal candidate will be a passionate advocate for a safe work environment, bring previous people leadership experience, and executive presence and strategic thinking.

Responsibilities:

The leader of the Physical Safety department will:

  • have a strong voice as a member of the EHS leadership team in shaping the EHS multi-year strategies, business objectives and operating model.  Support the Director and EHS leadership team in driving necessary changes to ensure the client experience is simple and delivers high value to the business.
  • guide the influence and impact of EHS as a strategic partner to the business in their risk decisions.
  • interact regularly with Genentech senior leaders on EHS-related implications for their business unit goals and operations. Work closely with the EHS team, senior leadership from internal business units, and key service providers to identify EHS-related risks, opportunities and trends, and develop sustainable solutions to complex problems.
  • evolve the vision and strategy for the Physical Safety function and ensure the needed capabilities (people, processes, and technologies) to meet emerging client business needs. 
  • provide technical and regulatory guidance on physical safety to leaders of the site and functional organizations to help ensure consistent regulatory compliance and timely adoption of relevant best-industry practices.  Establish effective management processes to ensure that the site complies with applicable laws, conforms to company standards, and utilizes best industry practices to manage safety risks to people, property, and the environment. 
  • provide strategic and technical support for a variety of EHS programs. Serve as functional expert/mentor for EHS staff and other employees across the site on matters related to worker protection and physical safety. 
  • oversee a team working on a diverse scope of complex EHS problems and initiatives.  Accomplish results through individual contributors and may have responsibility for other supervisory level individuals. Team members own programs and initiatives they manage and interface directly with clients. 
  • establish meaningful EHS metrics and present to Genentech senior leaders on a regular basis. Collaborate to develop sustainable plans to improve EHS performance while supporting the client’s business objectives.
  • coach, mentor, and provide technical and business support to staff members to enable their success.  Support staff members in establishing development plans that enable them to grow and succeed. 
  • partner with the site Security organization to establish an emergency management strategy for the site.  Will serve as a site safety officer for emergency response and recovery activities.

Skills for Success:

  • Ability to be strategic and forward-thinking, identify future needs of the organization, and consider the best solution/outcome for Genentech, internal stakeholders, and EHS.  Listens to key stakeholders, considers their needs along with the needs of the business, and makes well-informed decisions. Balances risk with practical business needs for speed and simplicity.
  • Skilled at seeing opportunities from challenges.  Track record of being resilient and adaptable in navigating organizational resistance and influencing others to adopt new behaviors and approaches.  Visible and dynamic champion for EHS.
  • Proven ability to successfully coach, develop, and lead a team of technical professionals.  Able to inspire and motivate teams. Strong emotional intelligence is critical.
  • Possesses strong executive presence and communication skills including the ability to effectively develop clear and concise messages from complex data, present to senior leadership and staff, and quickly gain trust.  Can translate data into actionable insights and communicates in a way that resonates—inspiring people to care.
  • Highly effective team player and collaborator.  Track record of partnering with and engaging others to realize change.  Strong comfort working in a matrix environment and leveraging expertise across functions.
  • Experience managing efficient operations, including effective business processes and metrics-driven alignment to achieve goals and budget.  Excellent planning and prioritization skills with the ability to multitask and be agile.

Requirements:
 

  • BS or higher degree from an accredited college or university with a major in a physical science, life science, engineering, safety, industrial hygiene, or other relevant field.
  • A minimum of 15 years of relevant work experience in safety, health, and environment (EHS) in pharmaceutical, biotech, medical device, or high tech industries.
  • A minimum of 5 years leading multi-disciplinary teams and directly managing people.  Experience leading employees, contractors and third party service providers is ideal.
  • Certification in one or more of the following areas is strongly preferred: Certified Safety Professional, Certified Safety Manager, and/or Project Management Professional.
  • Practical experience with Lean/Six Sigma business process improvement methodology, including a belt certification, is strongly preferred.
5/27/18 Product Integrity Investigations Specialist, Security - Site Services Individual contributor South San Francisco, California

Job Title: Product Integrity Investigations Specialist

Reports to: Principal Manager Product Integrity Investigations

Purpose:

Given the critical need to ensure the integrity of Genentech/Roche products, this new role is being created to provide support for all investigations related to the Genentech/Roche portfolio, which poses a significant risk to our patients, brands and reputation.   As part of the Corporate Security Product Integrity team, the incumbent will support the Principal Counterfeit Specialist and participate in cross-functional efforts in maintaining enforcement activities supporting the Global Roche Anti-Counterfeit group.  The position will be responsible for maintaining a comprehensive database system for all activities, electronic files and resource documents.

Primary duties and responsibilities:

  • Provides continuing investigative assistance to the Principal Counterfeit Specialist performing the full range of fact finding functions to include identifying and independently conducting additional research; determining type of information needed and most appropriate source; gathers and organizes the information, evaluates and assesses it relevance.
  • Oversight of a comprehensive case management system, continued development, update and maintain information and perform queries as required.   Maintains electronic files and resource documents.
  • Interacts on a regular basis with individuals in the public and private sector to obtain and share information and intelligence in support of investigative activities.  Establishes, researches, maintains and cultivates vital and extensive liaison contacts with a myriad of federal, state, local, private industry and public resources to negotiate and obtain information which may be of assistance and pertinent to investigations.
  • Responsible for market surveillance activities to include:  review of prospective targets, deconfliction, approvals, assignments to vendors, monitor status, handle chain of custody and transfer to other stakeholders both internal and external, prepares final report for dissemination (if required).
  • Develop mechanisms for the collection and dissemination of required and pertinent information relating to investigations by using a variety of investigative tools.  Provide the results to the Principal Counterfeit Specialist or other stakeholders to be used in decision-making and next investigative actions.
  • Maintains, controls, and processes evidence received by the Corporate Security group.  Ensures all guidelines are followed, necessary forms are complete and administrative requirements are met when preparing and sending evidence for analysis or destruction.

Works as a team member of the cross-functional Product Protection and Response team along with representative from Quality, Commercial, Legal, Regulatory, Government Affairs, Supply Chain, Packaging and Labeling and other stakeholders.

Continued contact with internal (Field Action Committee, Roche’s Global Anti-Counterfeit Committee) and external groups (other pharmaceutical companies, trade organizations, public health agencies and anti-counterfeiting organizations) to develop proactive measures for our product portfolio.

Works with vendors on investigative assignments to include initial referral to final work product.

Requirements (Include knowledge, skills and abilities):

  • Minimum 15 years of experience with the US government law enforcement/regulatory agency (FDA, DEA, Homeland Security, FBI) dealing with investigative activities. 

  • Ability to use judgment in evaluating and reporting of investigative findings, while working independently, without receiving specific instructions related to ongoing investigative, research and analysis work.

  • Ability to maintain liaison with individuals in a wide range of occupations/situations in order to obtain and exchange information.

  • High degree of discretion and acumen required due to the sensitive and confidential nature of the work.

  • Excellent research skills under tight deadlines and competing demands.

  • Strong oral and written communication skills are essential as is the ability to work together in a small office environment as a key team member.

  • Proficient in Word, Excel, Power Point and ability to present information in a graphic format.
5/26/18 Alliance Manager /Associate Alliance Manager Individual contributor South San Francisco, California

The OMNI Alliance Manager is accountable for cultivating and managing site relationships in collaboration with internal & external stakeholders to enhance delivery of the gRED portfolio.

Principal Responsibilities and Accountabilities:

Alliance Management

Management of ongoing site alliances

-Oversee day-to-day operational management of the OMNI Alliance

Site network, including:

• leading the development /maintenance of the Alliance portal

• driving the curation and documentation of Alliance

capabilities, certifications and qualification

• developing and maintaining Alliance infrastructure: Alliance

Agreements, Management Plans, Profiles, Playbooks, etc.

• driving documentation and reporting of site performance

• monitoring and reporting issue escalation and related trends

• developing materials and managing logistics for all Alliance related

activity both internal and external

-In collaboration with Alliance Lead, develop materials and manage

logistics for all Alliance engagement activities

-Drive coordination of Alliance site qualification activities, including site

visits and related outputs

-Partner with Alliance Lead to document and socialize best practices

-Contribute to site selection strategies for gRED OMNI programs

-Manage regular interactions with internal stakeholders (eg, Clinical

Operations, Clinical Science) related to alliance management activities

-Identify processes /systems that can be implemented to benefit Alliance

Management

-Serve as back-up for Alliance Lead, as needed

Alliance Development

Development of new site alliances

-Partner with Alliance Lead and other internal stakeholders to identify

potential Alliance Sites or Networks

-Support the evaluation of potential alliances /complete site audits

-Ensure site alliances are established according to ethical/regulatory/legal

requirements

These statements are not an exhaustive list of all responsibilities, duties, and skills required of this role, but are used instead to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills, capabilities and experience of the individual.

Education and Experience Required:

-Life Science degree or equivalent experience

-At least 5 years clinical development experience, with operations

experience highly desirable

-Experience developing successful relationships that support the business

preferred (alliances, vendors, etc.)

-Candidates with comparable depth and breadth of training and experience and

who meet job-specific criteria are eligible for consideration.

Skills and Competencies Required:

-Broad knowledge of the drug development life cycle and clinical trial

methodology, including solid working knowledge of GCP and ICH

-Well versed in clinical trial agreements and financial management

-Direct experience in negotiating and managing complex contracts and interfacing with legal, finance, procurement, and research & development within the pharmaceutical/ biotech industry

-Successful track-record of building and maintaining strong internal and external relationships

-Exceptional research and analytical skills

-Ability to distill complex information from multiple sources and draw meaningful conclusions and insights

-Able to resolve conflicts between study management teams and alliance sites

-Understanding of and insight into the interests and concerns of study centers

-Effective team player who has the ability to work internationally with multi-cultural teams in a highly matrixed environment

-Demonstrated customer-oriented and solutions-focused mindset

-Proactive and self-motivated attitude

-Willingness to challenge established practices and concepts

-Proven ability to support innovation even if taken outside of their comfort zone

-Demonstrated ability to drive and support change.

-Highly effective verbal, presentation, and written communication skills

5/26/18 Process Automation Engineer I/II Individual contributor Oceanside, California

Responsible for providing automation, instrumentation and control, and system level engineering capabilities and expertise to the Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Focus on providing long-term support for existing facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation impacting projects with small and/or focused scope. Provide input into strategic initiatives. 

Job Responsibilities

Essential

  • Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
  • Produce and review design drawings and specification documents (URS, FS, DS, etc.).
  • Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services.
  • Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
  • Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)
  • Initiate, execute, and track progress of change records.
  • Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
  • Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
  • Lead the start-up and troubleshooting of automation and critical process utility systems.
  • Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
  • This position may support Systems Automation projects, systems lifecycle asset replacement, system owner responsibilities involving automation change control, system maintenance, upgrades, and backup, disaster recovery.
  • Adhere to site SOPs and WIs for daily and project deliverables and provide improvements to business processes.
  • Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
  • Attendance and participation in department and staff meetings.
  • Maintain training qualifications.
  • Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
  • Automation lead for equipment/software FAT, field testing and commissioning.
  • Interact with vendors to ensure systems meet site requirements.
  • Provide scope, qualification, resource, and budget estimates for automation impacting projects.
  • Manage contractor staff, track project deliverables, and provide status updates to project team.  
  • Provide input into Master Plans and Project Plans with automation scope.
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.
  • Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

Job Requirements

Education and Experience

  • Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical,  Electrical, or Computer Science preferred) and 5 years experience, or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 4 years experience.
  • Minimum of 5 years applicable automation and/or instrument and control system experience.
  • Minimum of 3 years in the pharmaceutical/biotech industry/GMP experience.

Knowledge, Skills and Abilities

  • Experience with Biopharmaceutical manufacturing, design or/and construction.
  • Knowledge of process, utility and building control systems.
  • Knowledge of GMP guidelines, experience in generation of controlled documents.
  • Qualification experience related to control and computer systems.
  • Ability to generate engineering drawings and specifications.
  • Knowledge of ISA standards and practices for instrumentation.
  • Knowledge of PID control theories and techniques.
  • Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).
  • Practical knowledge of distributed control systems, and associated programming languages – (DeltaV and Seimens Insight Apogee Preferred).
  • Knowledge in computer programing and database languages such as OSISoft PI, Process book, PI Event Frames (EF), Asset Framework (AF), SQL, .NET, Visual basic, Business Objects, AgileDoc etc.
  • Experience in Virtualization (Hyper-V),DeltaV Virtual Studio, configure servers, hardware, software, networking, security and storage etc.
  • Experience with Emerson DeltaV Process control system (PCS) system infrastructure (preferred).
  • Familiar with configuring and maintaining Emerson Syncade Manufacturing Execution Systems (MES) or other MES (preferred).
  • Proficient knowledge of PLC/DCS, SCADA, managing interfaces to external systems including OPC Servers, interfaces to SAP and associated programming languages.
  • Familiar with Product Lifecycle Management (PLM), Trackwise, SAP, Electronic Document Management System (EDMS).
  • Knowledge of computer aided manufacturing automation.
  • Demonstrate good organizational and time utilization skills.
  • Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
  • Demonstrate good written and verbal communication skills.
  • Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
  • Demonstrate strong working knowledge of PC based programs and web based systems.
  • Ability to work most of the time independently with minimal direct supervision.
5/26/18 Intern - Research and Early Development - Discovery Oncology Entry Level South San Francisco, California

The mission of Discovery Oncology is to identify the critical proteins and pathways that maintain tumor cell viability, and to establish the potential therapeutic value of disrupting these proteins and pathways in cancer cells. This group also establishes molecular mechanisms that underlie sensitivity and resistance to targeted agents in order to develop a deep understanding of the heterogeneous nature of drug responses across the patient population and within the cell population that constitutes individual tumors.
We are looking for a summer intern with wetlab experience to work in the Discovery Oncology Department. The intern will contribute to efforts in the lab to mechanistically characterize the functional requirements of a novel oncology target. The ideal candidate will be proficient in the following techniques: RNAi, qPCR, and western blotting. A background in cancer biology is preferred.

BS, MS, or PhD student studying Biology, Biochemistry, Molecular Biology, Cell Biology, or Cancer Biology. Lab skills should include several of the following: cell culture, mammalian cell transfection, gene silencing techniques (RNAi or CRISPR/Cas9), western blotting, RNA purification, qPCR.

5/25/18 Senior Field EH&S Construction Manager Individual contributor South San Francisco, California

Purpose:

The Senior Field EH&S Construction Manager will conduct field safety construction inspections during the construction phases with Alliance Partner general contractors for the ~180 annual Design & Construction Portfolio Projects (valued at $100M).  Using the project-specific contractor-generated Safe Work Plans, review and approve all field conditions and behaviors as well as conduct field verification of identified EHS requirements per the EHS checklist and noted design requirements to ensure that these program requirements are being appropriately incorporated into construction project execution.  Identify the need for temporary construction safety measures (i.e. local area signage and construction safety signage) to ensure campus employee safety during construction.  Document all inspections, communicate to project teams and follow up on all findings.

  • Provide EHS support/guidance to non-Alliance Partner Large Project general contractors with respect to Genentech/Roche EHS field/construction expectations.  Conduct field verification of identified EHS requirements per the EHS Checklist and design requirements.  Identify and address any unacceptable field conditions or behaviors which put employees, the project or the contractors at risk.  Identify the need for temporary construction safety measures.  Ensure proper documentation by the general contractors of the field observations, communicate to appropriate D&C team members, and follow up on corrective actions.
  • Provide monthly safety information to PMs on Large Projects for their SSLT updates (THAs).
  • - Track and provide monthly and quarterly safety metrics for Portfolio projects (KPIs).
  • Develop and deliver key Safety Moments for D&C All Hands meetings as well as other higher level meetings such as Site Services and Managers’ meetings.
  • Lead a project safety leadership team/council (PSLT) comprised of the general contractor (GC) EHS representatives, key sub-contractors, site EHS reps, etc. to address GC and construction safety on campus.  Establish, develop and improve EHS related best practices in the construction industry.  Review RCAs, share lessons learned and create/manage a database repository for lessons learned with search functionality.
  • Support/co-lead a weekly Site Logistics meeting with multiple stakeholders (internal to Genentech and external partners) to ensure strategic approach to safe GC engagement and coordination with campus wide construction logistics.
  • Lead, organize and facilitate an Annual Safety Week, to recognize general contractors, sub-contractors, vendors, partners and Genentech staff (~500 people total) for their contributions to making our campus a safe place to work.  Budget is ~$20K.
  • Review RCAs (Root Cause Analyses) for contractor related incidents.  Facilitate (and lead where potential conflicts of interest) the RCAs for contractor-related incidents and near misses.  Lead, track and report out on incident investigations for contractor-related incidents and ensure proper follow up for assigned action items.  Share lessons learned with Design & Construction and Site EHS for improvements to Genentech safety programs.
  • Lead site-wide implementation of/improvements to the EHS, Site Operations and Security interests in construction field/safety.  Contribute to and influence developing EHS standards and regulations applicable to construction activities at Genentech (i.e. confined space, hot work permits).
  • Bridge cross functional relationships across Site Services and drive cross functional safety- related improvements with these teams (i.e. Security on Fire Life Safety Impairments).
  • Lead the engagement, collaboration and alignment between the Design and Construction department and the Site EHS department to ensure proper adherence to EHS requirements during construction project execution.  Host regulatory agency inspections, as needed, and manage the relationships with these agencies.  Support internal and external audits.
  • Establish a feedback loop between the Field Safety role and the Principle Design Safety Manager role within Design and Construction.

Qualifications:

  •       BA or BS in Engineering or related field
  •       Minimum of 10 years working with General Contractors and sub-contractors in a field construction related capacity; knowledge of proper PPE usage
  •       Minimum of 10 years working in an environmental health and safety or related field with an emphasis on EHS/field construction reviews, preferably in the bio-tech/pharma industry
  •       3-5 years experience supporting process improvement efforts
  •       Proficiency in MS Word, PowerPoint, Excel, Micro Soft Project
  •       Familiarity with g-Mail, g-Cal, g-Docs

5/25/18 Senior Manager, Governmental Affairs Public Policy (Washington, DC) Individual contributor South San Francisco, California

Government Affairs PPR Senior Policy Manager

Description

Genentech Government Affairs’ Public Policy and Reimbursement team is seeking a qualified Senior Manager, Public Policy & Reimbursement policy manager candidate to join the DC-based US Policy team to effectively advocate for changes to Medicare, Medicaid, and other public program coverage, coding, and payment policies.  Specifically, the Senior Policy Manager will help recognize, assess, and communicate key policy issues that may impact Genentech and the biotechnology industry in both the short- and long-term to internal and external stakeholders. He or she will focus on the impact of public sector trends and initiatives on Genentech with respect to patient access, reimbursement, and customer satisfaction.  He or she will translate policy developments into meaningful guidance and strategic advice and will represent the Public Policy and Reimbursement team at internal and external meetings. He or she also will be responsible for managing projects effectively and efficiently, and will be required to take initiative to identify issues and help organize and assist the efforts of other team members as appropriate.

Core Competencies

Qualified candidates should possess the following core competencies:

  • The Senior Policy Manager must be a leader who is willing and able to take responsibility and ownership for following and analyzing public policy issues and trends.
  • Qualified candidates must be highly motivated to take the initiative to further explore areas important to both Government Affairs and Genentech while working collaboratively with other team members in a dynamic and fast-paced environment.
  • Writing: Superior ability to write and edit business documents (e-mails, memos, and PowerPoint presentations) clearly and succinctly in a timely manner, as well as the ability to ensure content accuracy, appropriate tone, and attention to detail to ensure work is of superior quality.
  • Speaking/Presentations: Highly level of comfort and ability to present information to large group of internal colleagues and external audiences including customers.
  • Project Management: Strong planning and organization skills with the ability to set priorities effectively and efficiently, identify areas that need further research, and multi-task on a number of issues while notifying team members and supervisor of work progress in a timely and appropriate fashion.
  • Problem Solving: Superior problem solving skills, including the capability of applying previous experience to complex policy issues, and the ability to conduct or delegate qualitative and quantitative analyses.
  • Research and Analysis: Strong research skills, knowledge of sources of information and contacts on public payer issues, as well as the ability to tie research results and policy initiatives directly to Genentech’s business.
  • Word, PowerPoint, Excel: Advanced level of understanding of Microsoft Office, including PowerPoint, and Word formatting and graphics, and Excel spreadsheet programming.
  • The senior manager will work under limited direction and proactively notify his or her supervisor with work priorities and timelines; work will be reviewed for soundness of judgment and overall adequacy.

The position is located in Genentech’s Government Affairs office in Washington, DC.

Qualifications   

  • A BA or BS is required; a graduate degree (MS, MPH, MPP, JD or MBA) is strongly preferred.
  • Qualified candidates should have a minimum of 8 years of relevant post-college healthcare policy experience (examples include government agencies such as HHS, CMS, states, CBO, OMB, or FDA; Congress; healthcare consulting firms; pharmaceutical, biotechnology, managed care or other healthcare industries; or patient, provider or trade associations).
  • Experience working at or directly with HHS (CMS specifically) is preferred. Candidates should have an advanced understanding of the federal or state regulatory processes, federal or state regulatory bodies that monitor and implement the health programs, healthcare policy development, and the administrative structure of funding sources for government agencies. An advanced understanding of public payer coverage, coding, and payment policies is also required.
  • Candidates should also have experience in regulatory response and advocacy strategy development and execution.
5/25/18 Management Associate, Portfolio Management & Operations Individual contributor South San Francisco, California

This position will report into and support the Sr. Director of Project Management & Resource Planning. Administrative support will also be provided for the Sr. Director of Project Portfolio Planning (PPP). The position requires extensive knowledge of the Portfolio Management & Operations (PM&O) organization and an in-depth understanding of Genentech/Roche.

Interactions regularly involve complex and extremely sensitive information; the successful candidate will partner with both Sr. Directors and other staff to maximize the efficiency of the work groups. This position will also provide backup support for the Sr. Management Associate supporting the Sr. Vice President of PM&O.

Work duties include but are not limited to:

  • Identify and anticipate needs of the Senior Directors.
  • Be an integrated team member of the PM&O admin team to support complex projects and deadlines
  • Manage schedules with heavy calendaring of complex meetings with senior management stakeholders.
  • Arrange, coordinate and support meetings, events, and activities both on and off-site.
  • Generate, disseminate and maintain documents and information. Develop, implement and evaluate department work processes and procedures.
  • Manage travel activities, including planning and expense reporting
  • Ensure compliance with policies. Integrate and facilitate communication with individuals, the team, the department and other functions across the company.
     

Individual must possess strong, positive interpersonal skills and have the ability to work effectively with diverse individuals including executive level administrative assistants. The ideal candidate will be highly skilled in writing and interpersonal communications, independently enhance/adapt existing presentation materials based on general instructions and have expertise typically developed through a combination of job-related training and considerable on-the-job experience.

The successful candidate will be highly skilled in the entire spectrum of administrative duties and have a highly developed network within Genentech/Roche. The candidate will also be responsible for complex assignments requiring (a high degree of) technical expertise to resolve issues.

Proactive problem solving and decision-making within agreed parameters and a customer service orientation are essential.

Demonstrated successful experience indicating attention to detail, ability to work independently and in teams, strong follow up skills and ability to manage multiple projects simultaneously are required.

5 years (minimum) administrative experience in a management/executive environment supporting V-level/C-level executives

BA/BS degree in liberal arts or sciences or equivalent experience preferred

5/25/18 Sr. Systems Implementation Leader Individual contributor South San Francisco, California

Sr. Systems Implementation Leader

General Position Purpose / Summary

Study Team Support (STS) is part of the broader Product Development Global Operations (PDG) organization and supports the execution of clinical studies. The Senior Systems Implementation Leader (SIL) serves as the primary point of contact and business partner for PDG Study Management Teams (SMTs) for all clinical systems and services that Systems and Process Excellence (SPE) offer. SILs are accountable for the setup, implementation and operations of the PDG suite of clinical operations systems, such as IxRS and eCOA. SILs have a high degree of expertise in customer relationship management, e2e study management processes and systems, and vendor management. By partnering with SMTs, SPE SILs identify new business opportunities within scope of the SMT in support of continuous improvement and rigorous execution of clinical trials.

Primary Responsibilities & Accountabilities

  • Accountable to, and partners with the SMT and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials
  • Manage the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout
  • Understands business context and SMT goals to effectively partner with and continually assesses the needs of the SMT, to proactively translate business needs into system and process improvements
  • Serves as first line of contact for triaging all SMT support and service requests for each clinical study. Expert in all SPE support and service catalog, so as to enable rapid and focused decision-making or issue resolution
  • Ensures prompt resolution of system issues, and provides timely and accurate responses to customers. Is proficient and understands the PDG system landscape and applicable integrations
  • Proactively collaborates with other SPE sub-functions and beyond, to identify business needs and/or issues, and provides solutions to SMTs
  • Monitors PDG clinical system key performance indicators (KPIs) and contributes to analysis to identify root causes for defects, to recommend process and/or system improvements
  • Identifies process inefficiencies and compliance gaps, participates in process improvement initiatives and drives process implementation in support of SMTs
  • Develops strong relationships and maintains effective communication within PDG, as well as other functional departments within the company in support of business goals and improvements
  • Initiates, creates, maintain and provides training in areas of system and process expertise, in particular on STS services, to internal STS colleagues
  • Mentors new hires on PDG system landscape, SPE standards, problem solving approach, as well as SMT support
  • Reports into the SPE-Operations Study Team Support (STS) Manager

Education/Qualifications

  • Master’s degree or equivalent, with relevant certifications in project management, Six Sigma, or Computer System Validation (CSV) preferred
  • Minimum 10 years’ experience in Biotech/Pharmaceutical industry, with relevant experience in systems and processes, or equivalent

Experience, Skills, Knowledge

  • Knowledgeable with the processes and principles of program and customer relationship management, and business analysis
  • Up-to-date knowledge of clinical operations processes and information systems. Understanding of internal/external system landscape
  • Experience managing third party vendors in delivering quality service as expected
  • Ability to see and anticipate the interrelationship of systems and procedures within a project and understand their interdependencies – Systems thinking
  • Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
  • Previous experience in clinical trial planning and execution
  • Ability to successfully lead teams or change initiatives through implementation with little or no oversight. Proven as a successful decisive leader in a strategic multifunctional environment, with proven ability to navigate organizational complexities
  • Knowledgeable with Clinical Operations and Information Systems and processes such as IxRS, eCOA, CTMS, eTMF, RBM, EDC, and Clinical Supply Systems
  • Demonstrated excellent judgment in recommending and executing conventional and novel solutions to complex protocol-specific requirements, and simplifying the trial’s system landscape as well as sustainability
  • Demonstrated customer relationship management skills, and ability to create strong working relationships with respect to cultural diversity and working styles
  • Business partner and stakeholder management: proven experience in building and cultivating trustful relationships both internally and externally
  • Excellent networking and influencing skills, effective working/leading in global and cross-functional (matrix) environment
  • Experienced in business needs analysis, identification of gaps/opportunities and development of recommendations for improvement
  • Ability to drive results to successful completion independently
  • Analytical problem solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root causes and recommend solutions
  • Comfortable working in a fast-paced, dynamic environment
  • Highly proficient in functional tools such as Smartsheet (MS Project-equivalent).
  • Highly effective verbal & written communication skills
  • Strong presentation skills, and ability to convey complex pieces of information in a simplified and easy to understand manner while maintaining sophistication and nuance
  • Highly effective team player and interpersonal skills (globally, internal and externally)
  • Strong customer focus, and advanced influencing skills
5/25/18 Artificial Inteligence (AI) Engineer, gRED Early Clinical Development Individual contributor South San Francisco, California

Genentech’s Early Clinical Development (ECD) department is seeking an Artificial Intelligence (AI) Engineer reporting to the AI Team Lead.  The ECD AI group impacts Clinical Operations in trial design, planning and predictive tools.  The role will require cross-functional interactions with early research in discovery chemistry (CADD) and DMPK.  The AI Engineer will act as a consultant and be required to both establish and apply new AI methods to specific problem domains within those functions.

The AI Engineer will primarily be responsible for the development and the deployment of deep learning methods in early research with particular focus on the application to early discovery chemistry.  The main method will be a generative method for proposing small molecule with desirable predicted properties. The position will also apply AI methods to modeling in the DMPK and early discovery chemistry.

Responsibilities

  • Lead key AI pilots to ensure successful completion and develop plans to integrate capabilities into the normal early clinical development process
  • Development of new and novel Deep learning methods for reinforcement learning and generative methods
  • Application of deep learning methods to problems and support in early discovery and research with particular application to small molecule chemistry
  • Develop the software tools and library for application of deep learning methods, and train other colleagues within gRED and cross-Roche to develop and use the tools in their applications
  • Development of deep learning methods for adverse event prediction
  • Possess in-depth knowledge of multiple real-world data assets and share information about these data to business partners and the ECDi team.

Qualifications

  • Experience (7+ years) and a proven track record in software engineering, must have public and private repositories and track record of contribution to an open source package, such as DeepChem
  • Python, Tensorflow, Scikit Learn,  C++ PyTorch, DeepChem,
  • Strong analytical and problem-solving skills
  • Excellent oral and written communication skills
  • Ability to lead cross functional multi-disciplinary teams
  • Able to work in teams and collaborate with others to solve the most challenging business problems
  • OEChem, RDKit, SPARQL, and SQL are a plus

Education

  • Phd in Artificial Intelligence and machine learning with particular emphasis on molecular property prediction
5/25/18 Sr. Business Systems Analyst, SAP SD Individual contributor South San Francisco, California

The Senior IT Business Systems Analyst will be part of the ERP team to provide SAP based Order to Cash, Sales and Distribution (SAP SD) solutions. These solutions are delivered to the Genentech North America Commercial Sales Organization and Managed Care & Customer Operations teams. The solutions involve sales and distribution related configuration & developments.

The Senior IT Business Systems Analyst will understand strategic drivers and tactical needs to ensure that the team can provide solutions that meet the business need with the necessary stability, usability, and scalability.

This position reports to the Team Head for SAP Demand To Supply & Order To Cash North America and is based in South San Francisco, CA.

In order to support the user community, this role requires some flexibility in work hours and the ability to travel nationally & internationally, up to 15% as needed.

Responsibilities:                 

  • Review, clarify, document, and prioritize customer requirements
  • Design, build, test and deploy new functionality to meet business requirements
  • Create and maintain documentation such as user requirements, functional specifications and test plans
  • Facilitating and supporting system and user acceptance testing
  • Liaise with other SAP team members and IT teams to architect complete end to end solutions that optimize operational performance of systems
  • Perform knowledge transfer to training and communication teams and ?support user deployment activities as needed
  • Engage with Managed Services team to ensure appropriate resolution of incidents raised by business teams
  • Provide 2nd and 3rd level support as required and coordinate implementation of small to medium level enhancements
  • Engage in activities to support upgrades to systems including impact assessment, testing and support during cutover and deployment  
  • Participate in local and global projects
  • Help drive process improvement initiatives to optimize user experience and business understanding of solution
  • Keeping management apprised of developments through clear and timely communication
  • Participating in roadmap discussions and vendor assessments

This position is not eligible for relocation

Qualifications:

  • Minimum 5+ years SAP ECC configuration experience in SD. With some cross-functional skills in WM, MM, PM, APO and FI
  • BA/BS degree in Information Systems, Engineering, or relevant business discipline
  • Experience and understanding of SAP ABAP is desired
  • Background/experience as a Sr. consultant, functional expert or similar role is highly desirable
  • Experience with at least two full life cycle implementations
  • Previous experience in gathering business requirements and clearly translating into specifications for IT solution design (concept to production)
  • Must be able to work independently, interact with core team members, and be dedicated to drive system improvements without day-to-day supervision
  • Experience working in medium to large groups facilitating group discussions is required
  • Must be able to manage multiple priorities and projects simultaneously
  • Skilled in problem/incident management, SLAs – Service Level Agreements and full lifecycle system support
  • Excellent verbal/written communications skills. Strong presentation and negotiation/conflict resolution skills
  • Experience in Pharmaceutical, Biotech, or other validated environment highly desired
5/25/18 Instrumentation Technician (HTO) Individual contributor Hillsboro, Oregon

The Position:

Candidates must be available to work any shift, including weekends, nights and holidays. Currently, this shift is expected to be Swing shift, Wed-Sat. and is subject to change.

Responsibilities:

  • Responsible for the maintenance and calibration of all instrumentation and control system equipment within the Hillsboro Oregon facility to include utilities, Aseptic filling, Packaging, Automated Inspection and QC laboratory instruments.
  • Provide complex emergency troubleshooting and complex repairs of all the HTO site control systems and instruments in the areas of Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center.
  • Provide support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipment.
  • Ensure all assigned equipment and associated subsystems are operated and maintained in the following manner.
  • All instrument calibrations are performed at the appropriate interval and is completed by the assigned due date.
  • All equipment remains in its designed and/or validated state at all times.
  • All equipment operation is in accordance with Federal, State, Local and Genentech regulations, procedures, and policies.
  • Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
  • Cleanliness
  • Personnel and Equipment Safety.
  • Compliance to cGMP requirements.
  • Continuously evaluate the operation of all systems and associated subsystems at Genentech Hillsboro. Identify specific process improvement needs and provide recommendations for system upgrades.
  • Identify training deficiencies, provide recommendations for training improvement, develop new training materials and provide calibration OJT training to N1s, N2s and N3s.
  • Continuously evaluate all Standard Operating Procedures, engineering drawings and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to supervisor to correct any deficiencies discovered.
  • Create new Maintenance Strategy SOPs and Work Instructions as required.
  • Continuously evaluate maintenance/calibration practices to eliminate non productive activities and implement productivity enhancements.
  • Perform Confined Space Entry on an as needed basis.
  • Complete assigned scheduled and corrective maintenance in a timely manner following all cGMP documentation guidelines.
  • Work in close proximity to hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery/equipment.
  • Coordinate contractors who perform repairs, modifications, and installations of instrumentation, control systems, and associated equipment.• Perform installations of new complex instrumentation and process control equipment.
  • Perform complex instrument calibrations in accordance with standard operating procedures.?
  • Perform Variable Frequency Drive replacements and configurations.?
  • Perform complex configuration of the site’s instrumentation.
  • Work directly with Manufacturing, Engineering and various Quality organizations on new system installations or modifications and maximize equipment availability.
  • Conduct work in a GMP regulated environment.?
  • Participate in functional teams and cross functional teams as instrument subject matter expert support.
  • Identify and implement process improvements within functional group which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non- value added activities.?
  • Use project management skills to complete complex improvement projects by their due dates.

Job Requirements:

  • Must have full working knowledge of Predictive Maintenance philosophy and techniques.?
  • Must possess full knowledge of the fundamental operating principles of industrial process instrumentation and process control systems. Understands impact of equipment and system changes and alarms through BAS, DCS, Delta V, local and/or loop controllers and PI Process Book.
  • Respond and resolve more complex problem troubleshooting and repairs of all the HTO site control systems including Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center. Able to recognize and effectively communicate repetitive repair issues to management and provide solutions to reoccurring repair issues.  Ability to work on complex assignments and solve problems within situations ordinarily encountered. Typically makes decisions within established policies and procedures.
  • Must be proficient in ISA standards and practices for instrumentation?
  • Must possess a thorough working knowledge of PID control theories and techniques, relay ladder logic and programmable controllers.
  • ?A full knowledge of computer aided manufacturing automation.
  • ?Must possess the ability to create, read, interpret and revise engineering documents.
  • Demonstrates a full working knowledge of cGMP as pertains to job requirements.
  • Must be very familiar with all the Maintenance SOPs and WIs required to perform their job requirements.
  • ?Must possess strong documentation and attention to detail skills to ensure work orders, GMP compliance, safety and other regulatory documents are readable and error free.?
  • Practical understanding of OSHA, NEC, State and Federal regulations as applied to the equipment and operation.
  • ?Proficient in Microsoft Word, Excel, SAP, Gmail, Calendar, gWiz, DocLink, CEDM, TrackWIse, Filemaker Pro, and various Allen-Bradley VFD and PLC software packages.?
  • Must continuously demonstrate the ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high-pressure liquids and gasses, steam, varying electrical voltages and moving machinery.
  • Thorough working knowledge of system hazardous energy isolation to lead and perform LOTO of all the HTO site process systems.
  • Knowledge of and ability to use Computerized Maintenance (SAP) and Calibration Management Systems.
  • Must have full knowledge of shop tool operation and safety.
  • Ability to read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and have comprehensive computer skills using word processors, spreadsheets, databases, and email.?
  • Ability to perform maintenance and instrument calibrations according to Standard Operating Procedures and Work Instructions.
  • Able to adjust all the site’s instruments and repair instrument malfunctions.
  • Proficiency in understanding of Federal, State, Local and Genentech regulations, procedures, and policies.
  • ?Full knowledge of electrical switchgear and distribution systems in the medium to low voltage range and full knowledge of electrical safety requirements to be able to work safely on electrical systems rated at less than 600 volts and lead electrical troubleshooting events.
  • ?Demonstrates strong writing skills including preparing technical reports, creation of new documents, the revision of various technical documentation and procedures.
  • Demonstrates full ability to partner with and become a resource to customers.
  • Anticipates, identifies and defines needs.
  • Demonstrated ability to take ownership of customer’s problems.?
  • Demonstrates full ability to identify, assess, make decisions based on existing procedures and communicate actions taken.
  • Demonstrated ability to make appropriate decisions in the absence of management’s guidance. Typically makes decisions within established policies and procedures.?
  • Demonstrates full ability to identify and implement more complex process improvements within each functional group, which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non-value added activities.
  • Ability to use project management skills to complete improvement projects by their due dates.
  • Ability to lead groups in execution of projects.
  • Ability to support large cross functional groups in execution of projects.?
  • Demonstrated ability to lead and train other technicians in skills necessary for fully proficient in their roles.
  • Assists lead and other management personnel in tasks/personnel coordination.
  • Effectively work with general supervision. Minimal instructions or direction required on routine work and more detailed instructions given for new activities or special assignments.?
  • Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.

Who You Are (Qualifications):

  • Completion of an approved 2-year instrumentation or industrial Engineering curriculum at a technical school, or an AA/AS Degree in a related science or engineering major, plus a minimum of 3 years experience in manufacturing process control instrumentation or closely related jobs with a proven performance record, for Sr. level position.
  • Thorough knowledge of the fundamental operating principles of industrial process instrumentation systems.?
  • Thorough knowledge of ISA principals and standards.?
  • Strong interpersonal skills are a must.
  • Proficiency in both oral and written communications is essential.
  • Ability to lift up to 50 pounds

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

If you have a disability and need an accommodation in connection with the on- line application process, please email us at US.Accommodation@roche.com.

5/25/18 Media Prep Lab Services Associate Tech Specialist, Site Services Individual contributor South San Francisco, California

Media Prep Lab Services Associate Tech Specialist

The Media Prep Lab Services Associate Tech Specialist will be a member of the MOLS (Material Operations Lab Services) organization, which includes Material Operations, Media Prep and Lab Services Teams, working effectively within the organization to meet department goals and objectives. The Media Prep and Lab Services labs (MPLS) are responsible for producing microbiological media, various solutions, buffers, clean glassware, and prepared equipment for use in respective PTD, gRED and Quality groups. Specific responsibilities for this position will focus on preparation of stock solutions such as reagents, tissue culture and custom media as requested. Other responsibilities also include cleaning, sterilizing, preparing glassware and equipment.

This Associate Tech Specialist will be responsible for completing the following:

  • Developed technical proficiency in Media Prep and Lab Services, a subject matter expert resource to the teams and technicians  

  • GMP compliance and quality systems or R&D science fundamentals acumen

  • Ability to make quality decisions with limited supervision support

  • Be able to proactively identify process deviations and offer engineering solutions

  • Interface with customer groups and pursue cross-functional collaboration

  • Lead moderate to high impact process improvements that have a positive impact on MOLS and other organizations

  • Agility to rotate, flex and lead in other media prep and glass wash areas within MOLS

  • Represent high level initiatives (Technology, Inspection Management) for Site Operations and Site Services

  • Present projects and findings inside and outside of MOLS (e.g.  PTD, Quality, gRED)

  • Lead, support, delegate and represent functional and cross-functional projects or new assignments benefiting MOLS operations, customers, and local supplier network

  • 30-50% project work

Expectations:

Demonstrate Technical Expertise and strength including mastery in media preparation and glasswash. Perform operations free of operational variances and work with high degree of precision and accuracy. Demonstrate proficiency in all required training activities. Be a technical resource to the team and assist technician in resolving technical issues. Effectively train other technicians. Adhere to and reinforce GMP practices with other technicians.

Productivity by maximizing equipment utilization and ensure conformance with customers needs. Maximize production output including documentation and labor efficiency while meeting required safety and quality levels.

Teamwork and Collaboration. Work effectively within the team and department through collaboration and teamwork to complete assigned tasks. Involve the supervisor when events and decisions may impact safety, or production. Voice opinions constructively, while actively supporting and implementing agreed upon goals and decisions. Promote an atmosphere of teamwork and cooperation by assisting lead and supervisor in recognizing potential conflicts and offering to help team member.

Culture of Engrained Quality and Safety. Ensure the highest levels of quality in all services and materials provided to customer groups while maintaining a culture of safety. Adhere to all safety guidelines and procedures. Effectively respond to safety incidents. Immediately notify supervisor of safety incidents and hazards. Actively identify and resolve safety issues. Meet all compliance requirements for training and support team to create and ensure a safer work environment. Reinforce safety practices and provide safety training to other technicians.

Accountability & Responsibility by helping to monitor the team’s adherence to SOPs and departmental procedures. Ensure that work of team is completed by end of day. Help resolve operational issues as they arise. Participate in process improvement initiatives.

Communication. Excellent oral and written communication skills. Demonstrate professional conduct when communicating with peers, customers and supervisor. Provide routine updates to supervisor on progress, status, and issues associated with assigned tasks. Author or revise Internal Procedures and presents projects and findings.

Customer Service. Communicate with customers in a professional manner. Build strong communication and collaboration channels with stakeholder groups and individuals. Viewed as a subject matter expert, hold frequent discussions regarding quality of media and glasswash services.

Leadership. Demonstrate ability to organize team in the absence of supervisor. Provide positive example through technical proficiency, quality and GMP adherence, teamwork, and productivity. Effectively influences others to achieve goals. Assist team in assigning tasks and coordinate team events in alignment with department needs.

Requirements:

This position requires a strong background in media prep operation or related operational environment, with excellent communication, organization and customer services skills, and a passion for working in a team and executing high quality media preparation services.

Specific Job Requirements:

  • Possess a BS/BA in one of the life sciences plus 5 years of related experience

  • Understand and demonstrate proficiency with lab equipment

  • Strong interpersonal, communication, organizational skills: has proven abilities to work effectively and efficiently in teams

  • Passion for continuous process improvement. LEAN or other Operational Excellence training and experience a plus

  • Leadership skills: demonstrated ability to lead team if necessary, in a performance based, customer focused operational organization

  • Analytical skills: demonstrated strong ability to solve problems

  • Excellent oral and written communication skills

  • Successful demonstration of collaboration and teamwork

  • Must be a self-starter with strong focus on quality, attention to detail and delivering results

  • Must be able to work weekends, off shift and overtime as required

  • Must be able to provide technical support and training for new technicians

  • Computer skills: demonstrate ability to operate computers to enter work orders, purchase orders, notifications, etc.

  • Must be able to lift 40lbs and stand for extended periods of time

  • Must have a valid driver’s license, and clean driving record

5/25/18 Senior Managed Care Liaison Individual contributor South San Francisco, California

This position will report into the National MCL Account Associate Director.

Provide portfolio clinical product support to managed care account teams focused on United Healthcare and related accounts.

Provide account relationship support to managed care account teams by identifying and developing relationships with key decision-makers in managed care organizations and other institutions that purchase, influence or manage the use of Genentech products.

Contribute managed care business, health plan and clinical input to help shape product strategies for optimized access and formulary positioning for Genentech products.

Provide field support to generate applied science research demonstrating the value of Genentech products in real-world clinical use.

Provide USMA medical teams with the managed care perspective for strategic plans and tactics to translate of clinical science into clinical practice.

Assist in the development and implementation specific programs, tools and other resources to support Genentech’s value-based approach to medicine. 

Act as a conduit between the external payer environment and the HEOR in-house HEOR and managed care medical communications teams ensuring strategies and tactics are robust in filling key performance and evidence gaps from a payer perspective.

Provide scientific information and education to external customers, decision-makers and other influencers in response to unsolicited requests. 

Participate in other segment initiatives (employers, pharmacy benefits management organizations, etc.) to provide medical expertise internally and externally to support optimized access and product pull-through.

Attend and represent Genentech through advisory panels, advisory boards and other professional and/or policy-making forums to influence the healthcare debate and advance Genentech’s mission to be the leading biotechnology company in the U.S.

Comply with all laws, regulations and policies that govern the conduct of Genentech activities. 

Qualifications and Experience: unless stated as “preferred” or “a plus,” all other criteria are required

M.D., PharmD, or PhD with clinical expertise and experience.

A minimum of 5 years pharmaceutical/biotechnology and/or managed care industry experience (including managed care, disease management and outcomes research).

Excellent communication skills with experience in presentations to managed care industry customers, scientific organizations and medical/pharmacy associations.

Knowledge/understanding of managed care trends, pricing, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations.

Familiarity with current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry.

Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals.

Preferred:

Previous experience with pre-launch drugs, including developing materials

Previous experience in same or related Genentech therapeutic areas

Experience designing and/or presenting health outcomes research

Established relationships with key stakeholders in managed care organizations, employee benefits experts, and others are preferred.

Previous experience in other functions within the pharmaceutical, biotechnology or related industry is strongly preferred, e.g., marketing, field sales, field account management, health economics, government affairs, etc.

In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening).

Business travel, by air or car, is regularly required.

5/25/18 Biomarker Operations Project Manager Individual contributor South San Francisco, California

Position Purpose:

  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs) 
  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

  • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
    • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition) . 
    • Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
    • Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable
    • Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery . Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines
    • Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
    • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level 
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
    • Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the operations team and ensures reporting to the Biomarker Operations Program Leader (BOPL).
    • Supports the development of the biomarker analysis budget and manages it on a study level. Communicates variances in the budget to the BOPL or GSM as appropriate.
    • Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of Biomarker sample* metrics. 
    • Provides study level updates to stakeholders (BTALs & BOPLs), clinical study teams and biomarker teams including sample collection, assay status and analysis updates 
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
    • Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions
    • Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies
    • Provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
    • Attends operations team meetings and investigator meetings, monitor training, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection and handling procedures
    • Provides responses to biomarker sample* related questions or issues from Health Authorities.
    • Provides biomarker* operational input into the development of protocol feasibility questionnaires to ensure sites can meet sample-handling needs for the study
    • Provides input into the development of SMT goals.
  • Delivers the operational elements of the biomarker management plan
    • Proactively manages biomarker sample analysis and data delivery timelines and communicates any variances to the SMT, BOPL and biomarker scientists and implements contingencies in consultation with key stakeholders. 
    • Primary contact for internal and external stakeholders to maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action in collaboration with GPPS.
    • Actively partners with Data Acquisition Specialists and Data Management to oversee and coordinate biomarker data format and delivery timelines 
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
    • Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
    • Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
    • Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
  • Identifies areas of best practice and process improvements
    • Participates in Product Development Global Operations initiatives and programs as assigned
    • May lead or be a representative on functional groups goals, initiatives and work-streams 
  • Ensures study adherence to ICH/GCP and SOPs
*in some cases may also be applicable to bioanalytical samples in partnership with the bioanalytical managers


Qualifications:

  • Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
  • 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Skills & Knowledge:

Experience

  • Extensive clinical development experience with evidence of working in teams running clinical studies 
  • Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills 
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Planning, organizational and time management skills
  • Highly flexible in a fast pace global matrix environment
  • Professional interpersonal skills, excellent oral/written communication and influencing skills
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creates team culture and promotes team spirit.
  • Global Vendor Management experience preferred
  • Good knowledge of ICH GCP

Competencies

  • Strategic Agility
  • Inspiring and Influencing
  • Teamwork and Collaboration 
  • Communication
  • Technical and Business Expertise
  • Achieving Results

Other:

  • Some travel may be required
5/25/18 Clinical Safety Associate I Individual contributor South San Francisco, California

The Clinical Safety Associate I (CSA I) supports the drug safety staff in the day to day operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The CSA I supports study management activities in collaboration with other functional groups and supports the US Drug Safety Case Management Manager (CMM) in all activities. All responsibilities are performed under the direction of the CMM.

Key Accountabilities:

- Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) (~60% and as per business needs)

- Reviews, evaluates and verifies potential AE information to determine required action per internal policies and procedures

- Provides medical assessment on all cases for seriousness / validity / causality and conducts quality review of all cases (as applicable) including medical review of information entered in the safety database for completeness and coherency

- Performs follow up (e.g. Drug specific questionnaires / Pregnancy reports etc.) for all reported cases (as applicable) based on their assessment (i.e. Medically significant, non-serious, invalid etc.) to capture complete medical picture of an ICSR

- Medically reviews ancillary documentation accompanying Individual Case Safety Reports (ICSRs) and identifies medically relevant safety information for incorporation into the Global Safety Database

- Demonstrates understanding of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge

- Identifies and collaborate with external stakeholders for Antibody testing requests

- Responsible for identifying ICSRs requiring expedited safety reporting to Health Authorities. (~5%)

- Responsible for review and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS). Identify the need for creating additional or updating existing local Guidance Documents including but not limited to training matrix and identify appropriate target audience for training assignment. (~3%)

- Demonstrates a general understanding of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to support the protocol review process for supported/ funded studies (~10%)

- Perform Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche supported studies based on medical knowledge and European Union (EU) regulations

- Assists in reviewing Safety Data Exchange Agreements (as applicable)

- Participates and supports the Supported Research Team (as applicable)

- Assists in AE reconciliation and/or Case Transmission Verification (CTV) activities (as applicable)

- Acts as single point of contact for safety related issues

- Acts as Safety Liaison between Safety Science and Supported Research Team

- Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include (~10%)

- Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)

- Communicates and updates Team of any process related issues/ concerns

- Acts as single point of contact for safety related concerns

- Acts as Safety Liaison between Safety Science, Supported Research Teams (SRT) and Medical Team

- Responsible for medical review and updating of safety sections for documents e.g. pregnancy letters and notify appropriate stakeholders of any changes in executive summary of aggregate reports

- Assist in implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products

- Assists in projects under the direction of US Drug Safety management or project lead (~10%)

- Contribute to the preparation and development of Drug Safety presentations for internal/external stakeholders as applicable (~2%)

- Liaise with Compliance and Training (CAT) / Business Operations Analytics and Market Research and Patient Support (BAM) teams within USDS to ensure all processes are implemented

- Supports the onboarding and training of new personnel

- Provides support during audits and inspections

- Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs

Competencies Identified for Success:

- Demonstrates capability to comprehend medical information

- Works effectively, independently and collaboratively

- Strong organizational skills, detail oriented and adapts in a fast paced, changing environment

- Demonstrates ownership, initiative and accountability

- Excellent communication skills, both written and verbal

- Ability to prioritize tasks in a timely manner

- Ability to interact effectively in a multifunctional, multidisciplinary team setting

Qualifications

Education, Experience, and Other Requirements:

- Health Care Professional degree (e.g. RN/BSN/MSN, NP, PA, RPh/ PharmD/ B.Pharm or MD) (Required)

- Minimum 1 to 2 years of clinical or Safety related experience (Preferred)

- Writing experience; science/medical writing (Preferred)

- Computer proficiency (Required)

- Able to travel as per business needs

5/25/18 Associate/Medical Director or Associate/Medical Science Director (Neuroscience), US Medical Affairs Individual contributor South San Francisco, California

We are seeking a dynamic clinical scientist / preferably with a background in multiple sclerosis / neuroscience to join the US Medical Affairs group at Genentech. The Associate MD/MSD will provide exceptional clinical and strategic leadership for medical affairs activities including support for ocrelizumab post-launch activities. 

This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders in product development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to help drive effective pre-launch, launch and post-launch activities and to represent the department and programs at external meetings. 

As an Associate/ Medical Director or Associate/ Medical Science Director you are expected to:

Provide exceptional scientific expertise and collaboration within the Ocrelizumab medical team, to your peers within Neuroscience Group and to the organization in general 
Build excellent relationships and interactions between Medical and Global functions
Contribute to the formation, refinement and execution of medical strategies and tactics including Phase IIIb/IV activities, safety adjudication and exploratory data analysis
Ensure strategic partnerships with key opinion leaders in the area of multiple sclerosis patient groups and scientific institutions and societies to enable optimal collaboration for medical products throughout their lifecycle
Contribute and provide expert review of medical content for Medical Information and Educational activities
Ensure medical and product information is provided in compliance with Global and Genentech SOPs and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers
Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps
Provide leadership and guidance to Clinical trial activities conducted as part of Medical Affairs and provide medical oversight of the safety of local clinical activities
Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations
Ensure medical review and approval of all promotional materials in compliance with Codes of Practice, Genentech SOPs, and US regulations
Verify the accuracy of training material for scientific and product information and drug safety reporting requirements to the local organization (including the sales force)
Represent GNE Neuroscience Med Affairs externally through presentations at key National / International meetings, interactions with our key investigators 
Participate and thrive in an interactive, team oriented culture

Qualifications:
This position is located in South San Francisco
PhD, MD, PhD/MD or PharmD degree in a relevant scientific field (e.g. Neurology or Psychiatry)
Minimum of 2 years post-MD/PhD or PharmD experience in an academic and/or industry setting
Ideally experience in clinical drug development for multiple sclerosis or neurology or inflammation, including advanced understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine, Clinical Pharmacology, Regulatory, Safety, Clinical Operations.
Strong passion to drive clinical innovation to improve outcomes for patients Outstanding communication skills; ability to:
Lead, influence and motivate others
Navigate complex and difficult situations
Show strategic agility and ability to interface with multiple stakeholders
Distill complex issues and clearly articulate / present solutions.

5/25/18 PHC Associate Scientist, Analytics Individual contributor South San Francisco, California

POSITION SUMMARY
As a DATA SCIENTIST within our Personalized HealthCare function you will work with meaningful data to generate impactful evidence and insights on our molecules/ medicines and patients, that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access.

You will collaborate with peers within the function and across the organization to develop evidence generation strategies, identify evidence gaps and data sources, design and execute studies, and implement analyses to address molecule and disease area questions. The data will be varied in type -- patient-level clinical data, supplemented with deep patient data such as omics (e.g. genomics, proteomic), imaging, digital health, etc. Source data will be diverse -- real-world data (RWD), including patient registries, electronic medical records, claims, biobanks, and clinical trials. The evidence and insights will be used to inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments. This will require a good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical data science expertise. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to transform the way we use data and analytics to develop and deliver medicines for our patients.

As Data Scientist you will typically be responsible for a molecule/indication and partner with cross-functional teams and external partners with considerable independence. We have open vacanies for different roles focused on RWD, Omics and Imaging.

RESPONSIBILITIES

  • IDENTIFY EVIDENCE NEEDS & RECOMMEND DATA SOLUTIONS: Ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions.
  • DEVELOP DATA STRATEGY & GAIN ACCESS TO DATA: Develop strategic plans to access fit-for-purpose data sources to support evidence generation, and gain access to data through collaboration or data generation.
  • DIVE INTO DATA: Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.
  • BE AN EXPERT IN APPLYING METHODS: Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches. 
  • PRODUCE HIGH QUALITY ANALYSES: Apply rigor in study design and analytical methods; plan for data processing; design a fit-for-purpose analysis plan, assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable pharma industry regulations and standards.
  • INTERPRET AND SHARE RESULTS: Communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external meetings and forums to present your insights (e.g. congress/conference).
  • COLLABORATE & SHAPE: Collaborate and contribute to functional, cross-functional, enterprise-wide or external data science communities, networks, collaboratives, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, processes, etc. to enable broader and more effective use of data and analytics to support business.

MINIMUM QUALIFICATIONS

  • MSc, PhD or similar qualification in a quantitative data science discipline (e.g., statistics/ biostatistics, epidemiology, bioinformatics, health economics, computational biology, computer science, mathematics, outcomes research, public health, biology, medicine, psychology)
  • Demonstrated track record of developing and execution of data science research projects, patient-level data analyses (e.g., real world data, surveys, clinical trials, registries, claims, genomic or imaging data) with publications and presentations
  • Demonstrated experience with managing project scope and driving delivery in an evolving environment requiring proactivity and effective problem-solving and prioritization when faced with challenges
  • Demonstrated strong collaboration skills and excellent communication skills
  • Demonstrated entrepreneurial mindset and self-direction, ability to teach others and willingness to learn new techniques
  • Proficiency in English, both written and verbal
  • For Senior & Principal Data Scientist: Track record of effectively working in a matrix environment with global, international team members coming from scientific, business and operational backgrounds, using influence without authority

PREFERRED/ADDITIONAL QUALIFICATIONS

  • PhD degree in a quantitative discipline as listed in Minimum Qualifications
  • Fluency in statistical programming languages (R, Python, etc.)
  • Experience implementing advanced analytics approaches (machine learning, longitudinal data analysis, etc.) 
  • Experience with technologies required to undertake analyses on large data sources or with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc.)
  • Experience producing interactive outputs (Shiny, etc.)
  • Contributor to open source packages, libraries or functions
  • Experience implementing reproducible research practices like version control (e.g., using Git) and literate programming 
  • For RWD focused role: Experience analyzing RWD (non-interventional studies, electronic medical records, claims, disease registries etc.)
  • For Omics focused role: Experience analyzing next generation sequencing data, proteomics etc.
  • For Imaging focused role: Experience analyzing high dimensional imaging data in healthcare

5/25/18 PHC Senior Scientist, Omics Individual contributor South San Francisco, California

POSITION SUMMARY

As a Principal DATA SCIENTIST within our Personalized HealthCare function you will work with meaningful data to generate impactful evidence and insights on our molecules/ medicines and patients, that support R&D, advance scientific and medical knowledge, and enable personalized patient care and access.

You will collaborate with peers within the function and across the organization to develop evidence generation strategies, identify evidence gaps and data sources, design and execute studies, and implement analyses to address molecule and disease area questions. The data will be varied in type -- patient-level clinical data, supplemented with deep patient data such as omics (e.g. genomics, proteomic), imaging, digital health, etc. Source data will be diverse -- real-world data, including patient registries, electronic medical records, claims, biobanks, and clinical trials. The evidence and insights will be used to inform the research and development of our molecules, and support healthcare decisions by patients, physicians, health authorities, payers, and policy-makers. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our business and healthcare environments. This will require a good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical data science expertise. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to transform the way we use data and analytics to develop and deliver medicines for our patients.

As Principal Data Scientist you will typically be expected to contribute to broad therapeutic area strategies, lead and deliver on complex projects, and interact with external partners without supervision. You will drive the application of strategies and concepts and determines best course of action. You will drive creation of best practices, and proactively share learnings/experience with colleagues both internal and external to the function.

RESPONSIBILITIES

  • IDENTIFY EVIDENCE NEEDS & RECOMMEND DATA SOLUTIONS: Ask the right scientific questions, understand the evidence needs for research and development, regulatory and market access, and ideate and make recommendations on fit-for-purpose data and analytics solutions.
  • DEVELOP DATA STRATEGY & GAIN ACCESS TO DATA: Develop strategic plans to access fit-for-purpose data sources to support evidence generation, and gain access to data through collaboration or data generation.
  • DIVE INTO DATA: Develop a comprehensive and deep understanding of the data we work with and foster learning with colleagues using analytical tools and applications to broaden data accessibility and advance our proficiency/efficiency in understanding and using the data appropriately.
  • BE AN EXPERT IN APPLYING METHODS: Stay current with and adopt emergent analytical methodologies, tools and applications to ensure fit-for-purpose and impactful approaches.
  • PRODUCE HIGH QUALITY ANALYSES: Apply rigor in study design and analytical methods; plan for data processing; design a fit-for-purpose analysis plan, assess effective ways of presenting and delivering the results to maximize impact and interpretability; implement and/or oversee the study, including its reporting; ensure compliance with applicable pharma industry regulations and standards.
  • INTERPRET AND SHARE RESULTS: Communicate findings to internal stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities; publish results; participate in external meetings and forums to present your insights (e.g. congress/conference).
  • COLLABORATE & SHAPE: Collaborate and contribute to functional, cross-functional, enterprise-wide or external data science communities, networks, collaboratives, initiatives or goals on knowledge-sharing, methodologies, innovations, technolog

MINIMUM QUALIFICATIONS

  • MSc, PhD or similar qualification in a quantitative data science discipline (e.g., statistics/ biostatistics, epidemiology, bioinformatics, health economics, computational biology, computer science, mathematics, outcomes research, public health, biology, medicine, psychology)
  • Demonstrated track record of developing and execution of data science research projects, patient-level data analyses (e.g., real world data, surveys, clinical trials, registries, claims, genomic or imaging data) with publications and presentations
  • Demonstrated experience with managing project scope and driving delivery in an evolving environment requiring proactivity and effective problem-solving and prioritization when faced with challenges
  • Demonstrated strong collaboration skills and excellent communication skills
  • Demonstrated entrepreneurial mindset and self-direction, ability to teach others and willingness to learn new techniques
  • Proficiency in English, both written and verbal
  • Track record of effectively working in a matrix environment with global, international team members coming from scientific, business and operational backgrounds, using influence without authority

PREFERRED/ADDITIONAL QUALIFICATIONS

  • PhD degree in a quantitative discipline as listed in Minimum Qualifications
  • 6+ years of relevant work experience
  • Omics: 3+ years experience working with next generation sequencing data (DNA, RNA or epigenetic analysis), proteomics, etc.
  • Proven ability to translate and communicate complex study design and findings to diverse audiences

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.