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We are seeking a Sr Scientific Researcher in the Oncology Biomarker Development group within Development Sciences. The successful candidate will be involved in cross-functional project teams, and will play a role in reviewing and assessing the relevance of available biomarker data from clinical studies and will develop and assess scientific questions. He/She must be able to work in a collaborative environment and have flexibility in order to focus on high priority goals of the department and program teams. 

Job Responsibilities:

• Aid in the generation and analysis of large-scale, genomic, phenotypic, and molecular data from internal and external sources.
• Play a role in designing, developing and implementing biomarker strategies for identification of patients more likely to benefit from cancer therapy.
• Work with clinical scientists to implement and coordinate sample collection and analysis in clinical studies.
• Write, review and coordinate biomarker plans in clinical trial protocols, regulatory documents and collaboration agreements.
• Collaborate with internal and external scientific experts to build a disease strategy and identify novel biomarker strategies
• Establish, track, and maintain relationships and data exchange with collaborators.
• Can independently design and carry out experiments and/or data analyses that address significant drug developments questions.  Designs subsequent experiments and/or data analysis plans upon interpretation of data. 
• Develop new methods to address project needs, adapting them to their own needs or developing new protocols themselves. Serves as a resource for state-of-the art practice in areas of expertise
• Play a significant role in the accomplishment of departmental/team goals, that directly impact significant drug development decisions and milestones.
• Outstanding record of accomplishment in his/her field as evidenced by co-authored or primary authored internal technical reports, patents, manuscripts or regulatory documents such as IBs, INDs/CTAs, NDAs/BLAs, and responses to regulatory questions.
• Broad use and application of current theories and principles of Oncology and Immunotherapy, use of techniques of the relevant areas of science, drug and assay development.
• Effective communicator of ideas, project goals and results. Organizes and independently presents work at department, company and/or and project team meetings Presentations are clear and effective.
• Effective written communicator of ideas and results.  Independently completes internal technical reports and may be a co-author or primary author and manuscripts.  Writing requires little revision, and authors documents independently and of high quality. May independently contribute to regulatory submissions as appropriate.   May edit and review internal reports written by others.
• Actively participates, Demonstrates and fosters teamwork at the group, department, and team levels.  Represents department in team meetings. Acts as a resource within the department in a recognized subject or technology.
• Defines approaches and expectations to achieve pre-defined goals to team. Provides timely feedback.  Anticipates resource needs.

Candidate must have:

• Bachelor’s degree or Master’s degree and >6-9 years of work experience in related field, OR Ph.D. degree with optional postdoctoral experience 2-4 years of work experience in the related field.
• Outstanding scientific and organizational skills are a must.
• An interest in clinical development and oncology is required.
• Excellent verbal and written communication, and presentation skills.
• Independent and critical thinking and the ability to make data supported decisions.
• Familiarity with methodologies and platforms used for analyzing high-content NGS data. Contribute in the strategic development of personalized medicine in oncology.

*LI-gRED-NN2

On behalf of Roche/Genentech, the USMA Spectrum MU develops strategies for engagement in scientific and strategic discussions and collaborations with diverse external stakeholder entities across the many new therapeutic areas covered by Spectrum. The Scientific Collaborations group is accountable for leading and managing Genentech’s relationships with these aforementioned organizations and facilitates strategic and scientific discussions and decisions across key stakeholders. This group is also responsible for leading the Scientific Congress planning for major scientific meetings that span Neuroscience/Neurology , Hemophilia and our developing pipeline in Rare Diseases (in collaboration with GMA, gRED, pRED, and PD organizations).  

The Clinical Compliance Manager is responsible for activities related to GCP Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities in the Early Clinical Development (ECD) organization. Coordinating closely with QCO members this position provides expertise and support in all continuous improvement activities. This position will also partner with key internal business stakeholders and work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions/ outcomes. Incumbent will apply quality management and continuous improvement theory, technical principles, expert judgment proactively assist the business in the identification of potential risk and lead activities to ensure mitigation and improve ECD compliance and enhance performance of key ECD activities. Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.

General responsibilities include but not limited to:

• Collaborates with members of the QCO on the implementation and maintenance of the ECD Functional QMS in alliances with the Quality principles outlined in the ECD Quality Plan and QMS Handbook.
• Serves as a technical subject matter expert (SME) regarding QMS in support of departmental functions.
• Develops, modifies, and utilize tools to track and trend areas of deficiency, potential compliance issues, and clinical trial quality.
• Supports process improvement initiatives and prepares/analyzes quality metrics.
• Partners with assigned management and teams to track and report metrics
• Produces routine reports and status updates for management and leadership as requested
• Works with stakeholders to develop solutions and corrective actions to remediate gaps in identified areas of deficiency such as process improvements and/or training
• Assists in the revisions of procedural documents to drive and support in-house continuous improvement including streamlining processes and maintaining GCP compliance
• Manages follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA) and monitoring established controls after implementation.
• Participates in and supports internal audits and regulatory authority inspections, as required.
• Assists in the planning of compliance assessments including but not limited to vendor/contractor qualification when requested
• Participates in strategic, proactive planning of organizational activities, as required, with the goal of providing compliance expertise and to help ensure monitoring is efficient.
• Provides day-to-day support, and problem-solving expertise to applicable business partners to ensure business operations are conducted in full compliance with all relevant policies and procedures.
• Supports functional QCO objectives including risk assessment related initiatives that have a cross-functional and/or global impact as it relates to a critical compliance issue (s)
• Participates in department trainings, events and initiatives as required

Skills & Competencies:

• Applies deep understanding of GCP ICH, relevant Roche-Genentech, Early Clinical Development, Quality & Compliance Office & sub-function knowledge (e.g., policies, processes, events, tools and systems).
• Practical applications of Quality Management System of concepts, tools and regulations.
• Prioritizes and efficiently allocates time and attention, works in a structured manner and utilizes systems and tools to optimize own efficiency, follows through on deliverables by providing status updates and meeting expected deadlines.
• Identifies opportunities to improve processes.
• Applies good compliance practices, fiscal discipline, and environmental consideration in conduct of duties.
• Develops and maintains effective relationships at all levels internally and externally
• Addresses conflict constructively in an atmosphere of openness and trust
• Works effectively as individual contributor and team member in supporting functional and cross-functional projects.

Requirements/Qualifications:

• BS/BA degree with 10 years of pharmaceutical industry experience in drug development.
• Minimum 5 years directly related experience supporting drug development in a quality/compliance function /applicable compliance field.
• Knowledge of clinical drug development regulations and ICH GCP.
• Knowledge of QMS and CAPA related tools or systems is required.
•  Clinical Study Management, monitoring or audit experience is an asset
•  Experience with health authority inspections and inspection readiness activities preferred.
• Strong personal leadership with demonstrated competency interfacing with senior leaders is required
• Working knowledge of applicable US FDA, EU and ICH regulatory requirements and guidelines as applicable to clinical research.
• Excellent communication skills:
• Listening, interpreting and summarizing information
• Clear and concise verbal communication
• Professional and concise written communications –exceptional attention to detail
• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
• Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
• Strong project management skills: MS Word, Excel, PowerPoint, Microsoft Project, Visio, Google applications.

Provides analytical and specialized administrative support to relieve executive, administrative, and line and staff managers of complex details and advanced administrative duties. Executes special or continuous research and data analysis tasks. Analyses problems, determines approach, compiles and analyses data, and prepares reports/recommendations. Coordinates activities between departments and outside parties. Contacts company personnel at all organizational levels to gather information and prepare reports. Work is generally of a critical or confidential nature. Assignments may be found in various functional areas.

As a core member of the Roche Scientific Infrastructure (RSI) team, the Data Management Engineer will be responsible for developing and maintaining all aspects of the data management environment, including meta data management, indexing, tiering and archiving software solutions. Working closely with other members of the RSI team and Infrastructure Services the successful candidate will apply their experience and knowledge, partnering with the storage operations group to develop and deliver an effective, scalable, solution for scientific use at Roche.

The successful candidate is expected to be familiar with multiple platforms including NAS, block/attached, tape/optical with deeper expertise in object storage technologies. You would be responsible for contributing to the evolving development and use of object storage and associated software management solutions providing technical consultancy to ensure effective long term utilization of tiered managed storage.
 

Responsibilities:

• Contribute to the strategy and engineering of the data life cycle management and tiering RSI service and overseeing the operation of the service.
• Consult and partner with scientists to modify and optimize their workflows to efficiently manage data, tiering it for performance and long term discovery and use.
• Responsible for engineering and maintaining the API interfaces for the data life cycle management and tiering RSI service including the store, retrieve, index, search and archive capabilities (e.g. iRODS, samverna, mediaflux, etc.). 
• Dedicated transfer protocols (e.g. aspera, zettar, etc) to ensure Data Lifecycle Management services API’s are performant at scale and over long distances.
• Work closely with other members of the RSI team to ensure that all data managed by the data life cycle management and tiering RSI service can effectively and efficiently be accessed by all the other RSI services (cloud, container, HPC) and integrate with other core services (network, Identity & Access Management, automation).

This position is not eligible for relocation.

Qualifications:

• Bachelor’s degree (advanced degree preferred) in a relevant field of technology, science or business.
• 5 to 10 years’ experience with engineering storage systems and their integration and use in scientific environments.
• Experience in one or more object storage technologies and familiarity with at least one meta data management technology.
• Experience in tuning and optimizing high volume RESTful store/retrieve operations on high bandwidth/high latency networks.
• Experience in one or more scripting languages (Python, Ruby) used to automate data manipulation operations as well as definition languages (e.g. YAML/JSON) for maintaining configurations and data catalogues.
• Familiarity with one or more high performance data transport protocol (gridFTP, aspera, zettar).
• Demonstrated passion for excellence and ability to partner and deliver exemplifying the Roche Leadership Commitments

#LI-CG-MT1

Purpose:

Maintain the site’s Right to Operate and enable excellence in manufacturing by providing technical support to the production organization that results in safe, high quality, and continuously improving production.

• Continuously monitor, analyze, optimize, and ensure validation of ongoing operations (production equipment, automation, and production and cleaning processes).
• Anticipate, respond to and permanently resolve issues that arise during production
• Partner with external and internal functions to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.

Key Responsibilities

Leadership & People Management:

• 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 MSAT organization.
• As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the MSAT organization.
• Proactively promote positive Safety Culture and cGMP operating principles.
• Embody PT lean leadership principles and methods while fostering a continuous improvement mindset

Technical:

• Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department
• Direct areas of responsibility:
• Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements.  Represent Validation program during HA inspections.
• Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with PQS and HA requirements.
• Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
• Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections.  Drive continually monitoring of process to implement continuous improvement process
• Technical Services: Respond to and proactively identify issues, determine root cause, and solve forever: Develop, prioritize and drive continuous improvements and other readiness operational maintenance activities that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production. 
• Manufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring, master data and documentation management, compliance to Roche quality systems, and other readiness operational support activities
• For specific sites:  Pilot Plant Operations: Build and maintain pilot plant operations to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant.  Launch and PTD partner.
• Operate as one network: Partner with global MSAT teams and network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
• Serve as a core member of the relevant Technical Council, provide site contributions to network technology roadmaps, ensure funding and execution of assigned projects on the respective site level.

Requirements:

• Bachelors Degree required (science or engineering). Graduate or higher-level Degree is preferred.
• 12 or more years’ work experience in the pharmaceutical or related industry
• 8 or more years’ people management experience
• 4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment
• Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing
• Expert knowledge of clean room or classified area design/requirements
• Deep process, equipment, automation, validation and technical knowledge
• Possesses strong verbal and written communication skills and the ability to influence at all levels.
• Builds trustful and effective relationships
• Able to think strategically and translate strategies into actionable plans
• Takes responsibility, drives results, and achieves expected outcomes

Job facts:

Are you interested in working in an exciting and challenging position that will work across functions, across companies and across the world?

The Industrial Hygienist develops, coordinates, implements, and evaluates companywide health and safety programs.  This role will coordinate activities with manufacturing affiliates across the US, Canada, and Germany for the development, implementation, and sustaining the Roche Diagnostics global product safety, health, and environmental review process.

The opportunity:

• Conducts industrial hygiene investigations to anticipate, identify, evaluate and control exposures to chemical, biological, physical or ergonomic factors of employees or operations. Assesses safety and health risks associated with equipment, materials, processes, facilities, or personal abilities in order to identify and control hazardous conditions or actions that may cause injury, illness or property damage. 
• Manages various health and safety programs to ensure that the operations out of Indianapolis complies with applicable regulatory and company requirements, utilizes best-industry practices to identify and manage risk, and conforms to company directives and standards.
• Serves as the primary resource for assigned programs, providing related guidance and support to business areas, colleagues and management through training courses, inspections, written programs, and SHE website content.  Such program areas responsible for but not limited to: chemical hygiene, hazard communication, indoor air quality, respiratory protection, personal protective equipment, noise, and lasers.
• Direct contact with the Mannheim, Germany affiliate for the development, implementation, and sustaining the DIA global process for Safety Data Sheet development
• Provides support services responsibilities for US and Canada manufacturing affiliates around development of Safety Data Sheets that includes coordination of hazard communication for labels, classification of dangerous goods for shipping, and collaborating with site environmental on needs related to import/export and disposal regulations. Assists with government regulatory agency interactions relative to regulated health and safety programs, including reporting, notification, facilitating regulatory inspections, and ensuring closure of corrective actions

Who you are:

• Bachelor’s Degree from an accredited 4-year college or university with a major in physical science, life science, engineering, safety, industrial hygiene, or other relevant field.
• 5+ years (10+ years highly preferred) of progressive experience within an industry sector such as: automobile, diagnostics, chemicals, pharmaceuticals, oil and gas industry, or other relevant industries or a Master’s degree with 3+ years of experience.
• Professional certification such as a Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), Professional Engineer (PE), or ability to obtain.
• Knowledge, interpretation, and application of laws and regulation and the ability to identify issues and make sound decisions under conditions of risk and uncertainty.
• Ability to attain program specific certifications (e.g. industrial equipment, fire protection, confined spaces, fall protection, etc.) as needed. 
• Ability to operate chemical, biological, and physical hazard sampling equipment.
• Highly proficient project management skills, team building, and organizational ability to implement new projects and programs in a timely and effective manner and to arrange competing tasks into logical steps.
• Strong written and verbal communication skills:  written (business e-mail, technical documents, programs) and verbal (meeting leading, presentation, and training) 
• Strong interpersonal and negotiation skills necessary to develop and maintain smooth, cooperative working relationships and to drive change across business areas.
• Requires use of Microsoft Office suite packages
• SAP knowledge highly desired
• Must be able to learn and develop new areas of subject matter expertise. 
• Ability to travel approximately 10%

Please note this is a Night Shift position

Under the direction of the Filling Production Manager, the Aseptic Operations Supervisor will be accountable for Aseptic Production Operations of liquid or lyophilized products, including capping, tray-off and Automated Inspection.  Including overseeing drug substances thaw/compounding process and small part autoclaving and sterilization.  In addition to managing the responsibilities below, the successful candidate will need to demonstrate the following traits.

• Able to collaborate with both plant and corporate organizations seamlessly
• Has the passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers
• Embraces World Class principles and behaviors
• Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
• Is able to provide the leadership necessary to maintain a high performance culture

  Responsibilities:

• Ensure work environment meets Genentech and industry standards
• Create and maintain a safety culture that delivers injury and incident free operations
• Drive achievement of departmental safety performance targets and manage operations so that all departmental, functional and site objectives are met
• Reinforce safety practices/behaviors throughout the shift
• Provide oversight and support to ensure safety improvement initiatives are consistently identify and implemented
• Ensuring that all shift personnel have applicable safety training requirements assigned and completed
• Ensure the facility is always regulatory inspection-ready
• Participate in the development of quality goals and oversee operations to ensure targets and objectives are achieved
• Review trend data to ensure quality compliance and correct negative trends as required
• Reinforce quality practices throughout the department
• Provide oversight and support to ensure adequate quality improvement initiatives are appropriately identified and implemented in a timely manner
• Maximize production output and labor efficiency while meeting required safety and quality levels
• Manage operations to ensure that production, productivity, and financial targets and objectives are met
• Ensure business processes are followed and improved to deliver production performance at Class A levels
• Maximize equipment utilization and Overall Equipment Effectiveness (OEE)
• Apply operational excellence tools to define standard work, reduce process variability and steadily deliver measurable efficiency gains
• Ensure that Continuous Process Improvement teams are supported, trained and facilitated
• Manage the execution of the production schedule and shop order sequencing to optimize use of available capacity
• Maintain data and transactional sources required to support capacity models to understand real time capacity utilization and capability
• Comply with all company policies and procedures related to personnel management
• Manage and mentor the performance planning process for all direct reports to ensure their success Coach and develop leads, specialists and technicians via effective development planning
• Coordinate shift level hiring and staffing plans
• Complete all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc)
• Ensure lessons learned or best practices are shared across the department
• Leverage knowledge to maximize organizational effectiveness
• Identify and manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production
• Actively manage shift labor, overtime and spending to within the approved budget on an ongoing basis
• Review and approve manufacturing documentation including batch records and SOPs. Review and support closure of discrepancy records
• Participate in strategic planning, objective self analysis for compliance, safety and quality risks, and analysis of operational strengths, weaknesses, opportunities and threats

  Requirements/Qualifications:

• Bachelors degree in a science or engineering discipline or equivalent
• Demonstrated ability to manage people and projects. Ability to work with internal teams, partners, suppliers and customers
• Excellent written/spoken communication and interpersonal skills

  Desired:

• Possess a minimum of 5 years of progressively responsible experience in pharmaceutical manufacturing and specific experience in parenteral manufacturing
• Current understanding of FDA and EMA guidelines, cGMP’s for Manufacturing Parenteral Drug Products, including validation requirements
• Operational Excellence and Industrial Engineering skills
• Proficiency with validated change management, discrepancy management, inventory management, and production control systems

  Currently this position is on D Shift, which is a compressed night shift on the back half of the week. Work hours for this shift are currently Wed, Thursday, Friday and every other Saturday night from 18:00 to 06:00.

  The shift is subject to change based on the needs of the business.

Genentech is seeking a highly adaptable individual with strong technical expertise and a passion for delivering innovative solutions to join the Process Development Engineering (PDE) function within PTDUO (Pharma Technical Development U.S. Operations & Engineering) at our South San Francisco, CA site. As a member of PDE, you will have the opportunity to implement technologies in clinical manufacturing and to drive long-term technology and engineering initiatives related to the needs of both Process Development and Manufacturing.

Members of PDE are tasked with innovating and delivering technologies for Process Development and Manufacturing. A successful candidate will closely collaborate with customer groups, quickly learn new technologies, rapidly prototype, and deliver solutions that continuously advance the capability and efficiency of Process Development and Manufacturing. This requires a combination of adaptability to our fast paced environment, excitement for learning,  delivering meaningful solutions to our business, passion for Single-Use technologies and forthcoming communication skills.

PDE is comprised of a group of engineers with diverse skill sets. The department work leverages engineering principles, but specific technology areas evolve as required by the business. Current areas of focus include data management, data science, automation, new technology implementation and process engineering. This position will collaborate with multi-disciplinary team members to design, develop and implement novel single-use technologies and equipment for end-to-end integrated continuous biomanufacturing facilities of the future. The successful candidate will have the opportunity to add significant value in defining the future of drug manufacturing processes.

Responsibilities

• Tackle technology projects with passion and urgency. Leverage existing technical experience and rapidly learn new technologies to meet business needs.
• Provide exceptional customer service, technical support, and engineering services to customers and partners in Process Technical Development (PTD) and Manufacturing
• Collaborate with partners and customers within PTD and Manufacturing global network to ensure PDE is developing impactful technical solutions that meet customer needs.
• Innovate and challenge conventional assumptions to drive change and bring new technologies/projects to enhance our manufacturing operations (i.e. maximize success rates, reduce recurring discrepancies, increase capacity/productivity, increase levels of safety and/or compliance)
• Participate in internal and external collaborations that take calculated risks on new technologies that may provide the business with a competitive advantage in the future
• Influence the industry through participation in external communications, both written and verbal
• Support an engaging and fun workplace for all employees that fosters full engagement and collaborative problem solving

Qualifications

• B.S. in biochemical engineering or related discipline with 5-10 years related experience or a M.S. or Ph.D with equivalent combination of work experience and education.
• Significant technical expertise in one or more areas related to process development and/or manufacturing of biologics.
• Prior experience developing or implementing single-use technologies for flexible manufacturing
• Ability to work seamlessly with a diverse team of engineers to design and develop technology investments in collaboration with customer groups.
• Demonstrated record of technical innovation, including the ability to identify and implement novel solutions.
• Strong verbal and written communication skills. Must be able to communicate complex technical content and influence peers and leadership.
• Candidate must be comfortable with working in a dynamic, innovative and change-oriented environment.
• Prior experience working on integrated, closed and fully continuous production platform is a plus

Primary Responsibilities and Accountabilities:

• Contributes to the execution of the training operations plan and strategy
• Supports the test, upload, deployment of training programs required as part of the Quality Management System
• Acts as the Training System Specialist responsible for the end to end process and works closely with the
• Standard Operating Procedures (SOP) and Learning Solutions group in PDQS to ensure timely planning and execution of the training roll-out plan for procedural documents.
• Oversees the administration of global and local training programs within the Learning Management Systems, maintains and updates role-based training curricula, and delivers training compliance reports in accordance with defined processes.
• Leads Training System projects by incorporating concepts of Project Management Methodology (PMM)
• Collaborates with key business stakeholders to help ensure that global, functional and local training grids are accurate and current
• Performs quality checks on all training assignments, training deployments, metrics reporting and communication provided on behalf of PDQS Training Systems & Operations function.
• Communicates the training requirements to business stakeholders including completion timelines, curricula requirements for existing employees and new hires, in addition to providing status updates on all inquiries through the use of all available communication channels.
• Proficient technical and business expertise for all IT tools required to support the administration of the PDQ
• Training Quality System in a compliant and efficient manner and integrated training evaluation methodologies that measures training effectiveness.
• Provides Tier 1 customer service support and ensures issues (e.g., user requests, change control) are resolved in a timely manner.
• Generates innovative ideas and/or investigate potential methods in streamline workflow processes
• Ensures that business partner expectations for training operations and deployment are met.
• Contributes to the PDQS Training Systems & Operations & PDQS Learning Solutions Teams to set strategies and achieve the long-term goals & objectives for PDQS and PDQ as a whole.
• Well versed in all services and activities provided by PDQS Training Systems & Operations, PDQS Learning
• Solutions, and PDQ in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met.
• Provides training and knowledge sharing sessions to peers and to functional and affiliate Training experts

Education/Qualifications:

• Bachelor degree in Science-related subject or other related field or equivalent work experience.
• 3-5 years in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development.
• Experience in preparation and administration of GxP training programs.
• Training and Curricula development experience including oversight and administration of validated electronic training management systems
• Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams. Affiliate experience preferred.

Minimum:

• Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.

Desired:

• Substantial knowledge of all services and activities provided by PDQ, Change Management expertise.

Experience, Skills, Knowledge:

• Solid knowledge of GCP, PV and regulatory requirements.
• Customer focused approach, and highly effective teamwork and collaboration skills.
• Ability to build and maintain relationships with key business partners.
• Ability to analyze and simplify complex systems or processes into pragmatic solutions.
• Ability for problem identification/resolution in a complex environment or potential conflict
• Can effectively communicate, influence and lead both with and without authority.
• Proficient in project and change management methodologies
• Ability to work effectively in an international multicultural matrix organization.
• Fluency in written and spoken English.

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

Considering local candidates only. 

This role will be responsible for driving project teams that are focused on developing or improving new treatments for patients from Phase III clinical trials and beyond.

As a key member on project teams the Senior Global Project Manager (Sr GPM) is expected to be knowledgeable about the overall program in order to be strategic in planning, team management, and process management. Sr GPMs achieve this by delivering high quality project management support and other high value services to enable team and project success.
 

The Sr Global Project Manager is accountable for:

• Applying project management expertise, methodologies, & department standards
• Communicating effectively with team members, senior leaders, and the broader organization
• Leveraging well developed interpersonal skills to build & maintain positive working relationships with customers and key stakeholders
• Contributing to functional excellence and business improvement initiatives 

Planning

• Using project knowledge to be strategic in planning short-, mid-, long-term project plans and identifying interdependencies
• Developing, maintaining, tracking, and managing a high-quality, integrated project plan to enable accurate reporting and decision making
• Managing the critical path of the project and key project risks

Team Management

• Using strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings and high performance teams

Process Management

• Managing team-level and corporate processes effectively, using strong project and process knowledge, to drive team deliverables

This position reports directly into a Group Leader/Associate Director in the Pharma Portfolio Management (PPM) Global Project Management group. 

Qualifications:

Successful candidates will have a minimum of 15 years of relevant experience, to include experience in the pharmaceutical/biotech industry. A minimum of 10 years of Project Management experience supporting cross-functional teams in a scientific environment is also required, such as experience in clinical, clinical operations, regulatory, Chemistry, Manufacturing and Controls (CMC), device, diagnostics, vaccines, or Phase I-IV clinical trials. Pharma/biotech drug development experience is preferred.

• Demonstrated ability to think strategically when planning, managing teams, and managing processes
• Strong project management to enable precise execution
• Skillful use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance
• Excellent communication and customer service skills, which enable successful collaboration with executive level stakeholders internally and externally
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
• Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Proven leadership skills, executive presence, maturity, emotional intelligence
• Ability to work effectively with cross-functional teams
• Ability to work in a highly matrixed organization with geographically dispersed teams
• Ability to travel internationally (2-3 times per year)

Education:

• Bachelor’s Degree required. Scientific degree preferred. Advanced degree preferred.

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GENERAL POSITION SUMMARY/PURPOSE:

gRED’s Early Clinical Development (ECD) organization is responsible for developing and executing early development (Phase Ia – II) clinical strategies and plans to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for gRED new molecular entities (NMEs). These ECD strategies and plans enable decisions regarding initiation of pivotal studies (i.e., the life-cycle investment point [LIP] decision) and the initial scope of post-LIP development.  The Clinical Scientist (E4A) participates in the development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and ensuring effective and efficient execution of the Clinical Development Plan (CDP). gRED Clinical Scientists (E4A) are expected to perform their responsibilities independently.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Cross-Functional Team Leadership & People Management

• Leads or is a standing member of the Clinical Science Team (CST) (i.e., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives).

• As appropriate, can effectively delegate Clinical Science (CS) representation in cross-functional teams (e.g. Protocol Execution Teams) relevant to assigned molecule(s)/indication(s), and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CDP execution

• Working closely with the gRED medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions.

• More direct involvement w/ Clinical Development Plan (CDP)

• As assigned, participate in development of the long-range strategic plans for the assigned program(s).

• As assigned, participate in CS assessment of in-licensing opportunities

• Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and data quality plan

• May participate in Health Authority interactions

• May present at ad boards and other external forums

• Helps mentor and/or train new Clinical Scientists

• In conjunction with a Medical Director, creates and/or reviews clinical slides for internal and external meetings (i.e. Investigator Meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings).  Develop and QC data tables with biostatisticians to support these activities.

• Participates in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).

• In conjunction with Biostatistics and Medical Director, reviews appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.).

• Can author clinical trial protocols w/guidance

• Can advise on study analytical/data strategy

• Directs input into regulatory filings and other documentation

• Serves as a primary point of contact for study inquiries  (e.g., from internal function reps or CROs)

• Can train study site personnel

• Participates as a standing or ad hoc member of relevant sub-teams

• Supports others w/clinical documentation

• Conducts clinical data reviews

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

• Advanced clinical/science degree required (PharmD, PhD, MSN, MPH, etc.)

• Generally 4 or more years pharma/biotech industry experience OR is a recognized clinician-scientist expert in the field with equivalent clinical or laboratory research experience

• Generally 4 or more years experience with clinical trials

• 2 or more years relevant therapeutic area experience required

• Experience authoring full clinical trial protocols and/or study results and conclusions

• In-depth understanding of Phase I-II drug development

• Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance

• Comprehensive understanding of product and safety profiles

• Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

• Strong computer skills

• Preferred: Experience publishing clinical trial results in peer-reviewed journals

ABILITIES:

• Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies

• Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, gRED values

• Outstanding attention to detail

• Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

• Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

• Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance

• Excellent interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally

• Outstanding written communication skills

• Proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally 

• Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points

• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders (KOLs), etc.; stays focused and on-point, is able to raise problems or challenges in a productive and mature manner

• Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results

• Proven track record of effective decision-making: makes good business decisions and exercises sound judgment.  Consistently and effectively identifies and addresses important factors affecting clinical trial design and execution

• Aptitude or proven ability to manage others (can lead and motivate direct reports, prioritize and oversee their work through to successful outcomes, and support their career development efforts)

• Ability to travel globally (<30%)

*LI-gRED-KM2

Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the local CCO portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.   Principle Accountabilities and Responsibilities:   Provides Direction and Leadership to one or more LSTs: Builds effective, high performing LSTs through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit.  •  Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals. • Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST. •  Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized. • Liases with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training.   Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSM, functional management.   Represents the LST(s) at the SMT.   Maintain awareness of external clinical research practices to ensure the LST(s) and monitors are aware of the risks, priorities, value and impact of their work and contributions.   Establishes Study Timelines, Budget, Resource, Risk and Quality Plans: Provides the GSM with feedback from the local CCO perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.  •  Oversees project, protocol, site feasibility and determines site selection and patient allocation (total and annualized) with local CCO and the HQ study (GSL and GSM). • Analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT.   In accordance with the overall project plan, establishes and maintains accurate study level plans in PlanSource.  • Develops local CCO scenario plans that deliver the studies on time, with the most efficient use of budget and resources. •  Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSM. •   Develops and manages local CCO budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget. • Responsible for ensuring site level contracts are completed. •  Provides input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the local CCO via the GSM. • Provides input on local requirements for biologic sample plan to the Global Biosample Specialist. •In  collaboration with the GSM and where necessary, PDQ, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the local CCO and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies. •  Provide
s content review and input into the global communication plan. •   Develop

Position Scope

Program Manager is an individual contributor position for CORA Review. Incumbents in this position:

• Provide regulatory support to assigned products or business areas and projects
• Support senior staff members with cross-functional PRC coordination, communications and deliverables
• Work under the guidance of their managers or more senior staff members, including assigned standard work and any special projects
• With support, keep current in the areas of regulatory, healthcare compliance and ethics
• Have regular cross-functional interactions
• Typically operate with a planning horizon of 3 – 6 months

Example Duties and Responsibilities

 PRC and Team Support:

• Provide regulatory support for assigned products, business areas and projects under the guidance and direction of your manager and CORA Program Directors
• Under the guidance of a CORA Program Director or your manager, support PRC interactions, meetings, other communications and deliverables and effectively collaborate with cross-functional internal groups and external advertising agencies
• Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products
• Obtain and apply knowledge of Roche and regulatory guidelines, policies, procedures and best practices
• Maintain current awareness of evolving Food and Drug Administration (FDA) opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders
• Collaborate with others on matters relating to marketing strategies, implementation and promotion objectives
• Support the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies
• Provide regulatory input on commercial concepts and draft materials
• Support correspondence with the FDA and interpretation of FDA comments. Including follow-up on correspondence, such as resubmissions
• Keep internal partners and stakeholders abreast on various PRC/CORA activities and status
• Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations
• Program Manager (E3), Commercial Regulatory Affairs (CORA) Review
• As assigned, participate in special projects

Competencies

Successful candidates will demonstrate the following competencies critical to this position:

Technical and Business Expertise

• Applies emerging knowledge and trends in one’s area of expertise to improve results.
• Builds strong relationships with key customers.
• Contributes expertise to help colleagues within and beyond his or her area.

Teamwork and Collaboration

• Addresses and resolves conflict by creating an atmosphere of openness and trust.
• Establishes strong collaborative relationships. Inspires others to do their best work by offering support and encouragement.

Achieving Results

• Is goal-directed, persistent, driven to achieve objectives. Holds self accountable for meeting commitments. Recognizes the contributions of teammates and peers.

Qualifications

• Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
• Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)

Experience

• 3 or more years’ work experience (previous bio/pharma industry experience preferred)
• Must demonstrate previous project management, program administration, analytics and reporting experience
• Must demonstrate knowledge of, or the aptitude to learn, the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, offlabel promotion, PhRMA Code, etc.)

Additional Skills

• Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values, Competencies and Leadership Commitments (where applicable)
• Good verbal and written business communication skills: can be relied upon to communicate in a consistently effective and professional manner
• Good time management and organizational skills: consistently meets deadlines without compromise to quality of work
• Works well within teams
• Strong attention-to-detail, as demonstrated through consistent quality of work
• Demonstrates process-orientation: thinks through required steps and sequencing to ensure quality work output
• Ability to travel (<10%)

The Regulatory Informatics team is looking for a highly skilled and experienced Solution Architect with proven ability to apply architecture knowledge of systems and tools. The Solution Architect will help to enable a transformation of our system landscape. With that role you will apply your problem solving skills across the Regulatory Informatics domain in various project assignments. We are looking for an outgoing and open minded individual with high communication and presentation skills.

Further responsibilities are:

• Design business solutions which optimally support Regulatory business processes using standard and integrated software
• Maintain and support the core business and informatics processes and solutions within this knowledge domain and ensure smooth interface with other areas (IT, Clinical Operations, Document Management, etc.)
• Apply knowledge of systems and tools and problem solving skills to the support all domains in Regulatory Informatics (Submission Management, RIM (Regulatory Information Management) and IDMP.
• Applies extensive theoretical and cross-functional expertise in the in the context of company objectives to dependently address complex problems.
• Implement systems and monitor performance against defined standards
• Support Regulatory Informatics Archiving and Tracking, HA Commitments, Labelling and
• Submissions publishing technologies incl. Solution Lifecycle Management
• Maintain and develop knowledge of self and others within the technical domain
• Develops and delivers solutions to a variety of complex problems and initiatives
• Provide guidance to Technical Leads, and development teams as it relates to Solution Architecture standards and strategies
• Experience proving ability to develop, document and deliver design/architecture and configurations according to the business needs (defining models and specifications at conceptual and technical levels)

  For this position, you bring the following qualification:

• Bachelor’s degree or equivalent work experience in computer sciences, software engineering or similar
• 5 - 9  years of professional IT or other experience preferably within multiple technology (Study Management) or business domains -  Experience in IT Service Support and Service Delivery
• Experience in a Technical Lead role providing guidance, oversight, and day to day direction to one or more junior level developers
• In-depth experience in development of technical solutions that meet the needs of business processing for Regulatory
• Experience with ITIL, Project Management, CSV, Software Development Lifecycle Models in the healthcare industry is a MUST
• Fluent English skills (written and spoken). Flexibility to travel for up to 25% of time including outside of home country
• Flexibility to work outside normal working hours,  to support global implementations across different time zones

Reporting to Roche Diabetes Care's Head of Enterprise Architecture , the main goal is to build the world's leading digital ecosystems for diabetes management that enable the connection of the various stakeholders, including physicians, clinics, nurses, payers and patients.

The BU will be shaping the digitalization of Diabetes Care unit, offering to specific customer segments solutions and products to better manage diabetes. We hire people with a broad set of technical skills who are ready to take on some of technology's greatest challenges and help improve the lives of millions of patients.

Job Purpose:

• Participate in the definition of the architecture roadmap for an ecosystem of digital solutions
• As an architect, you do more than just sketch a system. You work with Engineers, Product Managers, Sales and Medical teams to recommend the best solutions that scale, are reliable and evolve according to our vision. Solving the problem is half of the job; you also figure out the solution
• As a Solutions architect, you serve as an expert for your partners and own the solution architecture for complex systems

Key Accountabilities:

• System design: specify and design solutions across business areas or systems. Evaluate and undertake impacted analyses on major design options
• Ensure that the system design balance functional, service quality, security and system management requirements
• Data drives our decision-making, help build decision leadership
• Design, maintain and manage architecture models, frameworks and artefacts
• Contribute to solution scoping and effort sizing with cross-functional teams
• Investigate operational requirements, problems and opportunities for cross functional initiatives
• Relationship management
• Stay informed on technology trends and product roadmaps to make informed recommendations
• Manage operational relationship with third party suppliers and consultants

  Key skills and Experience:

  Minimum qualifications:

• BS degree Computer Science or related field
• 10+ years relevant experience
• 5+ years relevant experience solution architecture
• Proficient in software development lifecycle, code management and release management in Agile environments
• Proficient in Linux environments and system administration
• Independent judgment and decision-making ability
• Good communication skills and excellent team collaboration
• Strong sense of ownership, urgency and drive

  Preferred qualifications:

• MS in Computer Science or related field
• 4+ years experience developing end-to-end web and mobile solutions
• Experience in Java and experience in scripting languages (Python, Perl, AWK) and Excel
• Experience in Amazon web services
• Experience working with globally distributed teams and 3rd party relationships
• Experience in Healthcare IT

As the Enterprise Security Architect, you provide security technology strategy and architecture leadership and direction to Roche Group worldwide. You ensure that security enforcement technologies and standards are used and applied to enable strong and seamless security in support of Roche’s business strategies and processes.Your main responsibilities are:

• To understand the business strategies and needs and developing security technology architecture to enable them securely 
• Analyze current technology environment to identify deficiencies and recommending solutions, as well as staying abreast of emerging security technologies and trends and apply them where appropriate
• Create compelling presentations to articulate the technical strategies, architecture and roadmaps to various levels in the Organization
• Work with Information Security group to define the strategies and principles that guide technology decisions and tradeoffs for the enterprise
• Consult on technical architecture implementation activities with all stakeholders and Solution Owners to ensure alignment
• Oversee and work with Engineering on the evaluation and selection of security related technologies and products.  Also, work with Engineering to define and create the standards and implementation patterns
• Identify the organizational impact and financial impact of the security enforcement solutions

Skills and Experience:You have a Bachelor's degree in computer science or equivalent experience and ITIL v3 foundation and CISSP, CISM, CISA certified (desired). Ideally, you have strong business knowledge in the Pharma/Biotech industry and associated processes and you bring the following qualifications: 

• 10 to 15 years of experience in IT security and risk management with medium to large global enterprises with global geographical typologies
• Accomplished in framing an enterprise IT architecture, proven to deliver against the original strategy and needs for the environment
• Experience with the topic of exchanging data (mergers and acquisitions, partnering, collaboration, sharing data, etc.), as well as with Cloud Security Concepts (SaaS, PaaS, IaaS), Mobile Architecture, Container security, DevOps,  IoT security, Network and Application Security and Data protection
• Excellent understanding technology domains like: security and privacy,  PKI infrastructure, IPSec and encryption technologies, Network and cyber security including LAN, WAN, WLAN, DMZ & Proxy, VPN, Internet etc., Identity management, access and authorization controls .   Single Sign On, Identity and Access Management solutions, End-point security, Monitoring and vulnerability assessment, Business Application security and risk management - business continuity and disaster recovery
• Ability to review proposed solution architectures, identify risks and provide remediation recommendations in line with established standards and overall security posture.

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we’ve only scratched the surface. At Genentech and Roche we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort.  

The Sr. Principal Product Manager will have end-to-end ownership of the PHC (Personalized Healthcare) Global Data Management Platform. This role will be part of the Pharma PHC IT/Technology Team that provides global technology solutions to enable the Pharma PHC Vision and Strategy. The Sr. Principal Product Manager will partner with senior stakeholders in multiple groups to design, develop and operate the PHC Global Data Management Platform for Roche/Genentech’s current and future PHC data management needs. The PHC Global Data Management Platform will manage large scale Global Scientific Datasets including Omics, Imaging, Digital, EHR modalities. This person will work very closely with key stakeholders in the PHC Center of Excellence to coordinate technology strategy with the PHC COE strategy and portfolio.

We expect the Sr. Principal Product Manager to be a passionate business and product advocate within IT, with proven analytical capabilities. The Sr.Principal Product Manager must be an effective negotiator, leader and communicator in working with Roche/Genentech’s multiple business units as well as with internal IT cross-functional teams. The ideal candidate will be a self-starter with a passion for data management products, a high level of flexibility, commitment, and a sense of humor. The Sr. Principal Product Manager will join our diverse community of smart, fun, wholehearted, and engaged informatics professionals from various functional areas. This person will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”
 

Responsibilities:

As Sr. Principal Product Manager on the PHC Pharma IT/Technology team, you will:

• Partner closely with key stakeholders from PHC Center of Excellence, Research and Early Development teams (REDs), Product Development (PD) and Commercial business groups, and corresponding Pharma IT Groups and Global Infrastructure and Solutions (GIS)

• Influence senior leaders across Roche and communicate PHC Global Data Management vision, strategy, goals, status, and impact

• Develop and document the Platform Vision and Strategy – Including all aspects to future roadmap, investment, innovation and experimentation.

• Collaborate with key stakeholders to gather detailed requirements and use cases for various data modalities, including Imaging, ‘Omics, Digital Health, and Real World Data (RWD).

• Transform detailed requirements and use cases into solution capabilities and map those capabilities to various vendor and internal technology platforms to inform architecture and solution design.

• Lead Implementation - Work with business, development/engineering & infrastructure teams to architect, design, prototype, develop the platform and ensure product deliverables meet expectations.

• Lead Rollout - Work with highly cross-functional teams to rollout the platform into various business groups and conduct/manage user training.

• Lead Operations – Including monitoring and response to customer feedback, continuous improvement and business growth

• Have a broad knowledge and leverage the technical capabilities of the internal teams and external technology providers and vendors.

• Help identify and manage third party vendor relationships and collaborations.

• Conduct market assessments and to identify new capabilities for existing and future business needs.

• Collaborate with PHC Portfolio Strategy and Architecture team to contribute to the PHC IT/technology roadmap

Qualifications:

• Bachelor’s degree in Biology, Computer Science, Mathematics, Electrical Engineering, Information Systems or related field; Master/PHD in Business, Mathematics, Science, or Computer Science preferred

• 10+ years experience leading technical products, applications and analytical systems

• 3+ years of people management and product management experience

• Demonstrated experience with full life-cycle product management: problem definition and solution discovery, stakeholder buy-in, validation, launch, and ongoing operations

• Strong Experience in designing and implementing high available and high scalable big data systems; 3+ years of experience in leading implementation of high scalable data management systems preferred

• Proven Domain Experience with and understanding of two or more the following data domains: Genomics, Imaging, Digital Health, Clinical Trials, Real World Data including EHR

• Solid understanding of AWS and/or similar cloud stacks

• Experience with data management lifecycle – Data Quality, Information LifeCycle, Data Governance, Analytics, Master Data Management

• Excellent communication (written and oral) and presentation skills; solid business acumen; well-honed influencing skills are essential.

• Self-motivated and team-oriented; able to work both autonomously and effectively as part of a geographically dispersed team

• Proven understanding with technologies like Spark, Hadoop, Flink, Cassandra, Elastic Search, TensorFlow and other big data & AI/ML technologies preferred

#LI-CG-MT1