Job Search

A postdoctoral position is available to study function and regulation of proteins involved in intracellular signaling relevant to human disease, with emphasis on understanding them at a detailed molecular level. Methods could include cellular mechanistic studies (CRISPR, mutagenesis, transcriptional analysis, proteomics), biochemical and biophysical characterization of purified proteins or complexes, and use or discovery of chemical probes. The candidate would join a highly interdisciplinary group including molecular biologists, structural biologists, and chemists, and would have the opportunity to interact with a wide range of researchers at Genentech. 

Past work in the lab has explored ligand recognition in Wnt signaling (PMID: 20093360; 21944579), substrate recognition by the Polycomb E3 ubiquitin ligase RING1B/BMI1 (PMID:21772249; 26151332), and regulation of the deubiquitinase OTUD5/DUBA (PMID: 22245969; 25470037). More recent work has focused on bromodomain epigenetic “reader” modules (PMID: 26365797; 27056325; 27190605; 27219867; 27682507; 28606761) and chromatin remodeling complexes (in press).

For more information on Andrea Cochran’s lab, please visit
https://www.gene.com/scientists/our-scientists/andrea-cochran

For more information about the postdoctoral program at Genentech please visit: http://www.gene.com/gene/careers/college/postdoctoral

Ensure the Vacaville site’s continuous Right to Operate and Employee Engagement (or Respect for People), by developing and sustaining proactive Safety, Health and Environment (SHE) program and procedures that comply with applicable laws, regulatory agency standards, and Corporate SHE directives, and that result in excellent SHE performance.  Promote a positive health and safety culture in the workplace. Also, are responsible for ensuring that employers and workers comply with safety legislation and that safety policies and practices are adopted and adhered to.

Working in a range of organizations, from multinationals to small consultancies, health and safety advisers plan, implement, monitor and review protective and preventative safety measures.

The SHE leader is responsible for site compliance with safety legislation and that safety policies and practices are adopted and adhered to.

The SHE leader will plan, implement, monitor and review protective and preventative safety measures.

 

• Partner with Group SHE, local SHE, and site functions to ensure site compliance with all regulatory agency requirements, and corporate SHE directives and policies 
• Partner within the Roche network to identify, share, and adopt best practices that reduce SHE risk at the site 
• As a member of the site leadership team, develop and drive proactive behaviors and mindset that result in an injury free workplace, and demonstrate respect for our people and environment 
• For specific sites: Responsible for all aspects of site security and health services
• Responsible for site compliance with all Federal, State, local and Genentech Environmental, Health and Safety codes, regulations and policies.
• Investigate accidents and incidents, where necessary help with updated designs along with other procedural changes to prevent re-occurrence.
• Represent Genentech to public, regulatory authority, trade groups and industry on all issues requiring SHE expertise.

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Establish strategic goals and objectives and maintain full strategic responsibility for the SHE organization.
• As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• As a site leadership team member, drive network activities and alignment, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the SHE organization.
• Proactively promote positive Safety Culture and cGMP operating principles.
• Embody PT Lean Leadership principles and methods while fostering a continuous improvement mindset

• Developing and implementing security policies, protocols, and procedures
• Controlling budgets for security operations and monitoring expenses
• Recruiting, training and supervising Security, Occupational Safety, and other SHE relates responsibilities.
• 10-15 % travel

• Develop, maintain, and continuously improve SHE programs at the site that comply with relevant regulatory agency permits, laws and standards, and Roche Corporate SHE directives and policies.
• Develop, practice and improve programs that ensure effective response in the event of a disaster or outage, with a focus on life safety.
• Inventory, prioritize, and proactively mitigate SHE risks across the site, through functional engagement and ownership.
• Build and sustain a strong leadership commitment to safety at the site, that is clearly evident on the shop floor and throughout the organization.
• Share and adopt best practices from across industry and the Roche network, through active participation in the SHE network council, Group SHE, and network forums. 
• Partners with and supports other Roche legal entities in the country for SHE related activities
• Acts as leader during site emergency situations
• Serves as Roche SHE Officer
• For specific sites: Maintain security of site premises, assets and personnel through oversight of site security operations, and health services.

The role primarily supports the Field Sales Management team and collaborates regularly with cross-functional teams including forecasting, sales comp administration and peer business units.

Incumbents in the role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

KEY ACCOUNTABILITIES:
Incumbents in the role are generally expected to:

• Provide expert guidance to internal customers in the assigned business unit in best practice incentive compensation plan design, implementation, communication and administration; ensuring sales incentive compensation plans help the business unit best achieve its vision, strategy, objectives and financial targets
• Lead the brand IC design team meetings and research all IC options that will help brand meet business objectives while motivating the field sales teams
• Continuously monitor field sales workforce performance against incentive plan metrics to ensure incentive plan effectiveness, efficiencies and accuracy
• Provide regular timely and accurate ad hoc analysis and reporting on incentive compensation trending, payments and other related items
• Provide budget and performance projections related to Incentive Compensation and track against actual monitor performance
• Manage the development and implementation of supplemental incentive programs and Awards & Recognition programs for all Franchise Sales organizations
• Work closely and effectively with other IC Sales Ops Managers to ensure and leverage, consistent best practices for all sales incentive compensation plans and operations across all GNE franchises. Ensure cross-franchise consistencies for incentive compensation plan design, implementation, communication and distribution
• Actively collaborate with Sales Compensation Administration team to ensure timely and accurate incentive compensation plan administration and management
• Continuously research and benchmark external best practices and other industry developments as these relate to sales incentive compensation; bringing this external knowledge to internal customers, partners and stakeholders.
• Develop strategic partnership with BU brand management and cross-functional teams as well as peers to ensure successful implementation of Sales Operations Initiatives
• Effectively and efficiently lead or otherwise participate in a variety of special projects, as assigned including functions of a Brand Sales Operations Manager
• Support and lead with his/her manager in the training and mentoring of less experienced team members
• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these. Will not compromise ethics or integrity, or undertake legal risks while pursuing business goals

The objective of the Enhanced Data and Insights Sharing (EDIS) implementation is to accelerate learning and insights generation across Pharma Research and Development by enabling the management, integration and sharing of biomedical patient data across Roche. This requires effective collaboration among Pharma Development (PD), the two Research Organizations gRED, pRED and the respective Informatics functions. Successful implementation of EDIS is a key enabler of Personalized Healthcare, the ability to tailor medicines, medical decisions, practices according to the individual patient based on their predicted response or risk of disease

 

Your main responsibilities are:

• Build a strong partnership with the EDIS Business Lead to co-lead the implementation phase and the EDIS Core Implementation Team comprised of representatives from across PD, pRED, gRED and Informatics
• Connect, collaborate and ensure alignment with related Informatics programs within pRED, gRED, PD and GIS as well as technology vendors where necessary
• Primary Informatics interface with the EDIS Steering Committee, the EDIS Leadership Team, and leaders from across the different IT functions involved
• Lead the sourcing and selection of technology vendors in alignment with the strategic objectives and business benefits of EDIS and in close collaboration with PD, gRED, pRED and work closely with the EDIS project and program managers to ensure all levels of the EDIS initiative are connected and informed of each other’s progress
• Accountability for ensuring the delivery of a fit-for-purpose, streamlined, user-friendly and robust EDIS ecosystem that’s fully aligned with current and emerging Roche IT standards as well as participating in various Informatics governance teams (e.g. NMPc, IPF, ILG) within PD, gRED and pRED as well EDIS program governance bodies as and when required

The Enhanced Data Insights Sharing (EDIS) team within Pharma Informatics is looking for a highly skilled Solution Architect. This position provides strategic architecture and technical project oversight for the overall EDIS programme. In this role you will work closely with the EDIS IT and business leads, multiple project teams including other architects supporting the EDIS portfolio, vendors and service providers to ensure delivery of the overall EDIS programme. This candidate will be proactive, collaborative, outgoing and detail-oriented with strong technical skills, excellent problem solving and written/verbal communication skills. This role will be expected to have a strong understanding and mastering of relevant new technologies and to introduce these, where appropriate and as needed, into the EDIS programme. This role will be expected to independently engage with technology vendor, to independently represent the EDIS architecture team in meetings and to prepare and deliver presentations to senior and executive management from time to time

 

Your main responsibilities are:

• Lead the development of the overall EDIS solution landscape and architecture, working cross-functionally between the research and early development business units and pharma development, to ensure alignment and buy-in of the overall solution architecture
• Is accountable for providing architecture oversight for all business applications within the EDIS IT portfolio and ensures the business strategies and priorities are supported by the right solutions and components. Influences the direction of related roadmaps and architecture to ensure alignment with EDIS
• Provide leadership in developing and maintaining the technical roadmap for EDIS solutions. Participation in the Global Architecture forums and input into the Technical Architecture Framework (TAF)
• Develops business/technical critical know-how within area of expertise. Assists in the development of others know-how by passing on knowledge of tools and techniques
• Participate in project teams and Architecture boards (e.g., pREDi, AE&O) to help guide the Architecture discussions and to ensure consistency across all EDIS projects in terms of technical alignment and direction

• Perform Assay History Review (AHR) function for in-process and finished drug substances to ensure compliance with Roche SOPs and policies; assume the responsibility of the COA Approver and ensure timely lot disposition of the drug substances.

QC Operations Support:

• Establish and maintain control limits for CQA and perform intra / inter-batch monitoring of CQA test results.
• Participate in the preparation of the Annual Product Quality Review (APQR) QC sections.
• Support the stability studies as a Stability Manager and /or site Quality Unit.
• Ensure that the management of reference standards on site adhered to the global standard policy.  Support the qualification and retest date extension of reference standards where applicable. 
• Participate in the development and execution of method monitoring assessment plans, which may also include the collections of monitored attribute data and retest information.

Discrepancy Management:

• Proficient in the global standard policy on handling of non-compliance lab test results and able to provide guidance to the QC department on complying to these requirements.

Quality Oversight:

• Provide Quality oversight of QC generated documents (e.g. SOP) and test data.

Compliance:

• Provide technical assessments for Change Control.
• Able to perform gap assessments and Local Impact Assessment for GSP implementations.
• Participate in regulatory inspections as required.
• Prepare training materials and conduct training where applicable.

Project Management

• Identify opportunities for continuous improvements.
• Provide technical and project leadership over Analytical Method Transfer.

• Responsible for the hands-on, daily supervision of GMP manufacturing operations and personnel within the manufacturing site(s).
• Participate in all aspects of personnel management (interviewing, training,
  coaching and developing).
• Responsible for all day to day operations in the GMP manufacturing
  suite, as assigned. Specific responsibilities will include:
• Hands on supervision and support of manufacturing staff.
•  Write and revise batch records, SOPs and solution preparation documents to ensure compliance to GMPs.
• Timely review of completed manufacturing documentation (Batch records, Worksheets, Solution docs., etc.)
• Schedule manufacturing staffs to ensure manufacturing timelines are met.
• Review production schedule and priorities to establish shift assignments.
• Ensure required levels of safety, quality and productivity are met.
• Work effectively within the management team to execute goals, objectives and tasks to achieve desired results.
• Provide assistance in problem solving manufacturing process issues.
• Timely reporting, investigation and resolution of manufacturing deviations.
• Serve as lead trainer on manufacturing processes and all related equipment.
• Provide cross-functional coordination and issue resolution.
• Coordinate equipment maintenance activities.
• Makes recommendations to management on matters relating to human resources, budget and department operations.
• Has contact with internal personnel and outside representatives concerning scheduling of specific projects or contracts.
• May be involved in conducting briefings and participating in meetings for internal and external representatives concerning immediate area of responsibility.

• Support the Biochemical Manufacturing Department by working effectively within the group to meet department goals and objectives. 
• Responsible for completing assigned tasks which may include preparing small equipment, cleaning and sterilizing vessels, preparing solutions, monitoring and operation biochemical processing equipment, raw materials sampling, dispensing and environmental monitoring sampling and maintain housekeeping of the areas while adhering to Safety, cGMP and Biochemical Manufacturing guidelines. 
• Assigned tasks must be prioritized and work must be documented per approved manufacturing formulae.
• Troubleshoot equipment and process problems.
• Support process improvement efforts. 
• Operate computers for process control and data entry. 
• Participate in staff and shift change meetings and work closely with other shift personnel and external support groups.
• Ensure all assigned tasks are performed as per safety requirement. Report safely incident and near misses on a timely basis and support SHE in incident investigation.

• Accountable to ensure that manufactured product meets Health Authority regulations, Company standards and expectations.
• Develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of Roche/Genentech products.
• Provide leadership and guidance to staff directing Quality functions., manage performance and development of direct reports to ensure achievement of organizational and departmental goals and a productive environment.
• Proactively prepare for and manage Health Authority inspections by assuring the site is operating in an “inspection ready” manner at all times. Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary.
• Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs.
• Perform other tasks as requested by Executive Management to support Quality oversight activities.
• Ensure that the in-process analytics and quality control comply with regulatory requirements.
• Ensure that the quality of the source materials for the production of the drug substances comply with the product-specific and legal requirements.
• Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

• Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long term goals.
• Lead, coach, and guide the organization. Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth.
• Build a strong pipeline of talent and robust succession plans for key positions.
• Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
• Be the champion and advocate for Engrained Quality at the Site.
• Build a culture of continuous improvement and model lean leadership principles.

• Partner with the Site Plant Manager on strategic business direction and decisions.
• Build and maintain strong partnerships with other site and network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationship.

• Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.

• Serve as final decision –maker and spokesperson for the Quality Unit.  This role is the decision maker for the Quality Unit at the site including heading the Quality Review Board.
• Establish and manage the Quality Unit organizational, managerial and accountability structures.
• Direct and provide guidance on all Quality matters, ensure and manage interfaces to other relevant Quality Units.
• Define the strategies needed to reach the site and network goals. Develop and communicate goals and metrics to ensure achievement of goals.
• Directly responsible for product testing, product assessments and product disposition of drug substance to meet standard lead-times.
• Provide technical direction and leadership to support the timely resolution of discrepancies and investigations.
• Provide technical direction and leadership to support routine audits as well as regularly visit manufacturing floor and QC laboratories.
• Lead Health Authority inspections and Third Party audits at the site and support other sites during inspections and resolution of network issues/risks as required.
• Work with internal business partners to proactively identify, communicate, resource and manage Quality and Compliance Risks in a timely manner. Ensure risks are managed to maintain our right to operate and quality supply to patients.
• Provide expert interpretation and sponsorship of PQS requirements to ensure that the site is operating in compliance to company requirements.
• Sponsor or lead the site Quality Council, chair the site Quality Review Board and be an engaged active member of BQC.
• Be a strong network partner through sharing of best practices and lessons learned.
• Actively develop employees, create of a climate of continuous improvement, high engagement and motivation, flexibility and agility.
• Build strong partnerships with the site leadership team to assure alignment around strategic priorities and day to day priorities.?
• Approval of contracts with quality relevant content (e.g. Quality Agreements).
• Lead and manage the Safety Health and Environment elements of the organization appropriately.

• Responsible for the hands-on, daily supervision of GMP manufacturing operations and personnel within the manufacturing site(s).
• Participate in all aspects of personnel management (interviewing, training,
  coaching and developing).
• Responsible for all day to day operations in the GMP manufacturing
  suite, as assigned. Specific responsibilities will include:
• Hands on supervision and support of manufacturing staff.
• Write and revise batch records, SOPs and solution preparation documents to ensure compliance to GMPs.
• Timely review of completed manufacturing documentation (batch records, worksheets, solution docs., etc.).
• Schedule manufacturing staff to ensure manufacturing timelines are met.
• Review production schedule and priorities to establish shift assignments.
• Ensure required levels of safety, quality and productivity are met.
• Work effectively within the management team to execute goals, objectives and tasks to achieve desired results.
• Provide assistance in problem solving manufacturing process issues.
• Timely reporting, investigation and resolution of manufacturing deviations.
• Serve as lead trainer on manufacturing processes and all related equipment.
• Provide cross-functional coordination and issue resolution.
• Coordinate equipment maintenance activities.

• Responsible for the hands-on, daily supervision of GMP manufacturing operations and personnel within the manufacturing site(s).
• Participate in all aspects of personnel management (interviewing, training,
  coaching and developing).
• Responsible for all day to day operations in the GMP manufacturing
  suite, as assigned. Specific responsibilities will include:
• Hands on supervision and support of manufacturing staff.
• Write and revise batch records, SOPs and solution preparation documents to ensure compliance to GMPs.
• Timely review of completed manufacturing documentation (batch records, worksheets, solution docs., etc.).
• Schedule manufacturing staff to ensure manufacturing timelines are met.
• Review production schedule and priorities to establish shift assignments.
• Ensure required levels of safety, quality and productivity are met. 
• Work effectively within the management team to execute goals, objectives and tasks to achieve desired results.
• Provide assistance in problem solving manufacturing process issues.
• Timely reporting, investigation and resolution of manufacturing deviations.
• Serve as lead trainer on manufacturing processes and all related equipment.
• Provide cross-functional coordination and issue resolution.
• Coordinate equipment maintenance activities.

The Senior RWD Scientist has the primary strategic, scientific and operational responsibilities for the conceptualization, design, conduct, analysis and reporting of RWD studies. The RWD Scientist is typically the lead RWD-S representative on cross-functional molecule and disease-based teams, and contributes to the development and execution of the global RWD plan. The RWD Scientist may also provide support to the creation of the clinical development plans and global medical affairs plans.

Major Responsibilities and Accountabilities:

• A leader of the RWD-S Disease Area Team. A lead RWD scientist on the cross-functional study team for RWD studies. Typically a member of a cross-functional team (e.g., drug safety, development, medical affairs)
• RWD studies: Leads RWD studies from conception to publication. Develops observational study protocols and analysis plans. Collaborate with external partners (e.g., key opinion leaders, academic institutions, CROs) on design and implementation of RWD studies. Develops analysis specifications in partnership with analysts. Authors study reports, publications, and presentations
• Contributes to regulatory submissions and Health Technology Assessments (HTA) in collaboration with global cross-functional teams
• Participates in the Health Authority and HTA meetings
• Influences clinical development plans and global medical affairs plans 
• Able to explain methodological strengths and work to minimize the impact of limitations of RWD
• Maintain knowledge of observational research methods and their application
• Maintain knowledge of health data sources for therapeutic area 
• Participates in RWD-S functional and other cross-functional initiatives

• As a core member of the Biomarker Subteam (BMST) and the Companion Diagnostics Project Team (JPT), within Development Sciences, the Clinical Biomarker Operations Leader contributes at a broad and strategic level by developing, implementing and overseeing the Biomarker and Companion Diagnostics Operations strategy for gRED programs. 
• The CBOL is accountable for the efficient delivery of biomarker operations across program(s) in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations.
• Provides program and indication- specific biomarker operational expertise, innovative and flexible operational solutions and options for the molecule’s Biomarker and CDx plan within the BMST and/ or JPT

Main Responsibilities and Accountabilities:

• Provides biomarker operational direction and leadership for one or more clinical programs to ensure the delivery of biomarker operational activities in line with the biomarker strategy
• Responsible for the leadership and alignment of the biomarker and companion diagnostics operational strategy for one or more complex programs
• Provides strategic context and delivers the molecule’s biomarker operations and companion diagnostics plan using therapeutic area and indication expertise
• Responsible for developing and executing the biomarker operations and companion diagnostics plan for a program including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources (in collaboration with gRED Biomarker Operations group leader), and development of high level operational strategies
• Ensure timely execution of patient selection/stratification for clinical trials by working with internal stakeholders (including global line functions) and external partners (clinical research organizations and academic labs) for assigned program(s)
• Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at a program level. 
• Chairs Biomarker Working Group meetings, if applicable, and other meetings involving internal or external stakeholders (Biomarker Scientists, Operational Functions, Data Management, Research Pathology and Vendors as appropriate).
• Optimize and drive specimen collection through presentations at Investigator Meetings and authoring study-related documents eg Pathology manuals
• Has broad understanding of the science and technology of projects and displays technical skills and knowledge required. Actively educates other team members through knowledge sharing. 
• Creates and manages biomarker operations program timelines, resources, budget, analyze risk and quality 
• Drives setting of biomarker operational program goals and milestones and monitors progress 
• Reviews the biomarker operational plan with the biomarker scientist for alignment within the TA, indication or molecule. 
• Responsible to communicate and to follow up on any relevant changes to the biomarker operations plan which require implementation across the program.
• Communicates initial budget, timelines and changes to stakeholders as appropriate.
• Oversees the operational implementation of the program biomarker strategies.
• Accountable for biomarker analysis budget forecasts, with appropriate input from vendors and biomarker scientists to ensure efficient expenditure and minimal variance between actual and planned spend. 
• Ensures biomarker analysis data is available in accordance with the biomarker program plan, as applicable
• Ensures escalation of issues and risks that significantly affect biomarker program timelines, budget or quality to the Biomarker Scientist, Clinical Operations, Clinical Science and Global Procurement (GPPS).
• Responsible for biomarker operations program-level decision making, risk identification and mitigation planning, ensuring escalation and resolution as appropriate.
• Provides direction and oversight of biomarker outsourced activities on a program level 
• Responsible for leading the aligned identification and selection of biomarker vendors in collaboration with the biomarker scientist and GPPS across a program 
• Contributes to contract and budget negotiations led by Business Manager.
• Maintains an overview of status and issues, and proactively communicate progress, challenges or changes that may impact timelines to relevant stakeholders, including Biomarker Scientists and Clinical Program Leaders.
• Manage and provide leadership, strategic direction for new staff
• May recruit and hire new staff, onboard/train new staff to comply with company and regulatory standards as applicable. Trains staff to a level of increased independence
• Mentors and coaches gRED Biomarker Operations staff and provides feedback to group leader, as appropriate, on individual’s performance
• Identifies and contributes to areas of best practice and process improvements
• Provides program leadership to matrix teams within gRED Biomarker Operations by providing program specific guidance, clinical biomarker operations expertise, strategies, best practices, lessons learned and direction to achieve results
• Ensures successful handover to PD Biomarker Operations when program has moved to late stage. Continue to provide Biomarker Operations expertise and operational strategy even after program LIP, in cases where PD BMO resource is not yet identified/onboarded.
• Onboard/train Biomarker Operations for PD and US Medical Affairs 
• Works with scientific stakeholders to identify novel and innovative biosample collection and processing techniques and ensures logistical feasibility across a program
• Represents Biomarker Operations or takes a leadership role in non-molecular projects (NMPs) and actively contributes to the optimization of existing as well as the development of new processes within and across Therapeutic Areas (TAs) and across the broader GNE/Roche organization e.g. Global Human Specimen Management Policy, Pharma Respository Governance Committee, Global Protocol and ICF template development, etc. 
• Leads by example and creates a positive work environment by encouraging mutual respect, innovation and accountability at all levels
• Ensures biomarker operational program adherence to ICH/GCP and SOPs

Relocation is not designated for this position. 

Position Purpose;
The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs). The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.

According to an Affiliate's local resourcing situation, the responsibilities of this role can be covered by the CSM role.

Main Responsibilities and Accountabilities;

• Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.
• Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable).
• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.
• Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
• Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
• Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.
• Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
• Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.
• Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.
• Coordinates study or country communication plan.

Principal HRBP, IMPACT Business Unit in U.S. Commercial

Reporting to: HR Director U.S. Commercial Business Units

• Strategic business partner to leaders and leadership teams (LTs)
• Consult, advise, coach and partner with the business on people and organizational needs
• Ensure alignment with agreed group, functional and regional initiatives as well as business strategy and ensure successful local execution
• Drive organizational effectiveness including change management for assigned client groups
• Influence the overall people strategy; partner with leaders and LTs to develop and implement the people strategy/agenda for the business
• Execute global and local HR processes and decisions and ensure meaningful communications
• Develop and drive local HR initiatives that meet key business needs (aligned with global requirements

The Principal HR Business Partner is the HR business partner for the IMPACT Business Unit based in South San Francisco.  This position is part of the U.S. Commercial and U.S. Medical Affairs HR team.  This role is the strategic business partner to leaders and leadership teams within the client organizations.  This position manages complex/matrix relationships, collaborating effectively across business and HR networks/partners.  The person in this role will consult, advise, coach, and partner with the business on people and organizational needs – ensuring alignment with agreed Group, Genentech HR, functional, and regional/site initiatives as well as business strategy.  This role also partners with leaders to drive organizational effectiveness, including change management.

• Act as key HR point of contact, thought partner and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business while taking into account the broader implications (e.g. Group HR strategy, Genentech HR strategy/goals, other functions)
• Contribute to the business strategy.  Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication.  Plan and implement people/organization solutions aligned to the business, Group HR strategy, Genentech HR strategy/goals, and/or function goals.
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, divisional and global functional HR initiatives.
• Act as trusted advisor to managers and employees.
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business.  Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development.  Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services at affiliate level based on costs, ratios and appropriate Key Performance Indicators.  Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards, and other known relevant policies and guidelines.

This position is not eligible for relocation.

CORA is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Regulatory Labeling Program Managers are assigned their responsibilities by products, across varying product development phases, as business needs dictate. Regulatory Labeling Program Managers are responsible for providing strategic and operational leadership for labeling of pharmaceutical products and devices, including the generation of and revision of U.S. package inserts (USPI) PDF’s, and package labeling. Program Managers are typically assigned less complex responsibilities and perform their work with increased supervision by comparison to Regulatory Labeling Program Directors. Program Managers may also provide support to Regulatory Labeling Program Directors who are directly responsible for leading and managing commercial labeling activities.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Supports development of the cross-functional regulatory strategy for each product or related assignment by providing regulatory labeling expertise, insights, perspective and recommendations in conjunction with guidance from management and/or mentor
• Participates in and supports the process for timely development, maintenance and revisions for product labeling for pharmaceutical products and devices, including:
• Coordinating preparation of documentation package supporting proposed Labeling changes
• Communicating Labeling changes to internal partners and stakeholders, including affiliates
• Supporting the implementation of Labeling changes into the local labels
• Collecting and archiving the supporting documentation package for initial development and subsequent updates of Labeling in appropriate internal database systems
• Supporting creation and maintenance of systems that support labeling.
• Specific compliance focused responsibilities for this new role include:
• Implementing new processes to increase compliance of artwork for BLA/NDA/HFS filings and during FDA negotiations.
• Updating pertinent SOP’s, GSP’s and guidance documents for the roll out of ALPIN 2.0
• Assessment of current checklists and development of new tools to aid in the artwork process
• Evaluation of current FDA guidance and regulations and incorporation into Commercial Labeling requirements document
• Training CML and other stakeholders on new compliance process
• May participate in ongoing RAFT meetings. Including providing ongoing expertise regarding regulatory labeling, guidance on compliance, timing and other relevant matters
• As requested, provides support to Regulatory Labeling Program Directors pre-and post- cross-functional meetings, other interactions and communications, which may include support in generating meeting minutes, distributing information, conducting post-meeting follow-up, etc
• Works collaboratively with global labeling personnel at other sites to ensure sharing of best practices and to enhance quality and consistency of processes
• Participates in and/or otherwise supports development and implementation of new or updated PDR and/or CML-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, processes, or other relevant tools. Includes efforts to build greater efficiency into the Labeling process
• Responsible for embodying a culture of compliance in all aspects of job performance. Completes required compliance training as assigned. Identifies and escalates any potential compliance violations immediately to ensure they are addressed appropriately

*This is a 12 month internship opportunity

*Looking for recent graduates able to start in late summer 

Clinical Operations in Product Development is responsible for the effective planning and implementation of clinical studies on a global level.  Teams managing the clinical programs are located in 5 headquarter sites across North America, Europe, and Asia. The clinical operations teams plan and deliver high quality clinical programs evaluating the safety and efficacy of our molecules for numerous diseases including oncology, immunology, ophthalmology, respiratory, and psychiatric diseases.  These programs meet scientific, medical, regulatory and patient demands for new and innovative medicines globally. The results of these studies form the basis of regulatory and commercial approval of medicines.

The position of Therapeutic Area Business Operations Intern will support data driven decision making across all therapeutic areas within Clinical Development Operations.  The position will assess and analyze relevant data sources and identify trends, signals and bottlenecks in therapeutic area segments, countries and sites.   The basic mission of the position is to identify areas of improvement, elucidate the root cause, and propose improvement plans all by using available data and multivariable analyses.  

Primary Responsibilities and Accountabilities:

• Collection, analysis, and dissemination of data required for data driven decision making
• Develop predictive and forecasting models to inform operational strategy
• Develop tools for automating data processing, cleansing, and manipulation
• Deliver analytical business solutions to the clinical operations organization
• Evaluate and utilize most appropriate analytical methodology and visualization platforms
• Partner with IT groups to plan, design, and implement technological solutions
• Obtain and validate information from appropriate data sources for internal, competitive, and market dynamics analyses. 
• Communicate findings by compiling relevant information, synthesizing key actionable insights, and delivering impactful formal and informal presentations to therapeutic area leadership, clinical country operations leadership and other PD/PDG stakeholders.
• Actively contribute to clinical operations strategic planning efforts by providing unbiased, objective, in-depth analysis and insights on current and future trends in relevant countries and therapeutic areas.
• Partner with patient recruitment and competitive intelligence teams to assess relevant competitor actions and develop an understanding of underlying impact of competitor’s strategy on Roche’s clinical operations portfolio. 
• Monitor and report landscape of industry standards for clinical operations to support clinical operations business needs 
• Understand the mechanics of the forecast, resource, financial, and predictive models. 
• Possess knowledge of clinical development organizations, relevant analytics concepts and methods and clinical informatics systems.

Experience and Competencies:

The ideal candidate will:

• Be a highly motivated individual with strong analytical and quantitative, problem solving, organization, communication and presentation skills.
• Have experience in transforming data into compelling insights and strategies.  
• Have demonstrated ability to identify and synthesize reliable and current information sources into a comprehensive and accurate understanding of business reality
• Have a track record of integrating and synthesizing findings from multiple sources to enable informed strategic decision making and business insights 
• Work well individually and demonstrate effective people/team skills
• Have excellent communication, interpersonal and persuasion skills
• Have a passion for healthcare industry and rigorous analytics

The Interactive Marketing Department Operations Senior Manager is accountable for propelling planning, communications, operations and employee engagement across the Interactive Marketing department and with key partners. This role reports to the Senior Director of iM, and is a key member of the iM Senior Leadership Team (iM SLT).

Key Accountabilities & Responsibilities
• Strategic Planning
• Develop, drive planning and oversee execution of iM’s long-term strategic plans
• Orchestrate planning and execution of 3-year planning, annual tactical planning and quarterly business review processes
• Develop iM’s annual performance scorecard and track performance quarterly
• Develop and oversee iM’s annual roadmap calendar
• Manage iM’s quarterly and annual awards programs

Communication & Knowledge Strategy
• Develop and manage iM’s intradepartment communication strategy
• iM lead for interdepartmental communications (Commercial Portal, GNE/CBO events, etc)
• Optimize iM’s information and knowledge management practices and process
• Align and execute IM internal communications and calendar
• Active participant on cross-functional operations team

Compliance & Finance Operations
• Ensure iM department training compliance (full-time employees, contractors, agencies/vendors)
• Ensure compliant contractor and agency/vendor procurement, engagement, on-boarding and off-boarding
• Manage Finance Operations Manager (1 FTE) and other contract resources as needed
• iM lead for Commercial Finance & US Commercial Services (includes CCG & AMS)
• Oversee compliant and efficient iM contract and finance processes, major milestones, and overall department financial performance (Headcount & Outside Spend)
• Evolve contract and finance strategies to meet changing iM and business needs
• Oversee reliable agency and vendor monthly reconciliation process
• Oversee iM’s preferred agency program, including orchestrating agency training and evaluation

Employee Engagement
• Develop and manage IM employee feedback process
• Pull-through key CBO and iM culture initiatives
• Nurture department wellness
• Promote productive open space working environment

Demonstrated strength in the following important competencies:

• Communication
• Achieving Results
• Managing Change
• Strategic Agility