The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to biotherapeutics programs.

Responsibilities:

Successful Scientist candidates will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of biotherapeutics project teams, work closely with Study Monitors, Pathologists and Pharmacokineticists to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired. In addition to activities listed, Senior Scientist candidates will provide independent leadership in the design and implementation of safety assessment strategies for Genentech’s project portfolios and lead or provide support to interdepartmental and cross-industry initiatives. May provide supervision, mentoring, and career development to toxicologists.

Job Summary:

Working in early clinical development at Genentech /Roche Inc gives the opportunity to provide translational safety contribution to projects combining good understanding and knowledge of toxicology and expertise in clinical safety and early clinical development, a very innovative approach where Genentech/Roche is a pioneer. 

Job Purpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to products in early development phase including single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit/risk (in collaboration with Clinical and Regulatory) throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate to ensure that adequate safety measures are implemented based on data. ¿The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for safety components of various documents including study protocol, study reports, development study reports. The Safety Science Leader represents Safety Science in Research and Early Development teams (RED teams) . She/ He supports and facilitates transition of projects from early to confirmatory development for all aspects pertinent to safety. 

Primary Responsibilities and Accountabilities:

·      Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 

·      Reviews all communications to the public from a safety point of view. 

·      Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 

·      With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.

·      Is accountable for safety components of all NDA documents. 

·      Is responsible for the writing and maintenance of RMP/REMS NDA documents. 

·      Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  

·      Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 

·      Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates.

 People Leadership: 

·      Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 

·      Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  

·      Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.

·      Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 

·      Actively installs the Roche values in the Safety Team and their activities.

This position involves global medicine development activities of a novel biologic agent targeting indications in the field of respiratory diseases.

This job creates a unique opportunity to join a global team that is currently defining its structure and both short-term and the long-term deliverables, and to grow with the team and the franchise.

 As the Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also participate in developing the long-range strategic plans for the molecule or molecules within the area of inflammatory diseases.

Key Accountabilities will be:

Assisting in the overall management, planning, evaluation and documentation of projects and studies

Participation in on-going medicine development activities including:

• Preparation of regulatory documents and interaction with global regulatory authorities
• Monitoring and reviewing incoming data
• Analysis, presentation and interpenetration of on-going studies and published data
• Interactions with health authorities and expert bodies
• Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
• Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
• Developing and writing clinical plans and protocols ensuring that they are scientifically sound

To be successful in this role, you will have the following skills and experience:

• Solid experience in medical research including writing clinical study reports and interpreting clinical data
• Good communication and collaborative skills with experience at working with cross functional and external groups, including researchers, clinicians and other stakeholders.
• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings

The Clinical Pharmacology Department at Genentech, Inc. isseeking a Ph.D. level Senior Scientist who is driven to understand the clinicalpharmacokinetics and pharmacodynamics of novel drug candidates in the area ofOncology.  This individual will beresponsible for the clinical PKPD activities of Biologics, Antibody DrugConjugates and/or Small Molecules in clinical development. This person willhave responsibility for the Clinical Pharmacology strategy in order to ensurethat appropriate dose/route/schedule decisions are made using the state of theart modeling and simulation strategies that are aligned with project needs.This will be accomplished by working in close partnership with Clinicians, Biostatisticians,Clinicians and project teams.  Responsibilitieswill include planning and reviewing study designs, analysis plans, data analysis,interpretation of PK/PD as well as planning, implementation and organization ofregulatory filings (worldwide) and presentation of data at cross-functionalteams, department meetings, conferences and regulatory meetings (worldwide).Additionally this individual will also be directly involved in leading projectsub-teams and representing the function at cross-functional project teams.

This position may be filled at a Manager, Analytics & Compliance - E4 or a Sr. Manager, Analytics & Compliance level - E5
 
Manager, Analytics & Compliance will support Government Pricing & Reporting (GP) teams and collaborate with key business partners, including other Strategic Pricing & Contract Management (SPCM) teams, Distribution Strategy, Government Affairs, Finance, Legal and Brand Marketing to deliver deep insights and actionable strategic and tactical recommendations that enable Genentech to rapidly and appropriately adapt to evolving U.S. government payer practices, policies, relevant legislation, regulations, trends and other dynamics . Frame and structure approach, research, analyze and synthesize information on the changing/evolving external landscape and internal strategic proposals for implications to government calculations, pricing and other related activities. Perform complex, strategic analysis of Medicaid, Medicare and VA/FSS data, including advanced forecasting, predictive analytics and trending, in order to proactively address current and future scenario planning, solve for “what if” type questions from stakeholders, and determine the impact of regulatory and other relevant changes.

Analytics & Compliance Managers play a leadership role representing Government Pricing & Reporting to cross-functional teams.

Analytics & Compliance Managers also play lead roles supporting GP Calculations and Medicaid Claims processes by advising on impacts of regulatory and other relevant changes to government payer claims and rebates and developing GP methodologies.

Acts as a subject matter expert and trainer on government payers and programs, as these relate to government pricing, contracting, administration, reporting and related matters.  Incumbents in the Manager/Senior Manager Analytics & Compliance role, as all other employees, are fully accountably for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

Technical Skills: Actively Provide Strategic Support and Regulatory Impact Analyses to Relevant Business Partners [relevant business partners – see above description]

• Conducting Analyses & Scope and Structure Key Strategic Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. Proactively seek out complex information on changes in laws and regulations. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights. With some support and guidance from manager provide strategic insights and recommendations to relevant partners by linking learnings across projects. Assess appropriate use of secondary research and internal data, leveraging internal expertise and resources as appropriate. Develops appropriate responses with supporting analytical justifications, including recommended changes in complex pricing and contracting strategies. Complement quantitative analyses with government payer and program knowledge to provide qualitative recommendations regarding potential implications or other impacts to Genentech’s business.
• Develop and Maintain Analysis Tools. Conducts quantitative analysis of government payer programs’ data to identify and provide data-driven insights and support government reserves forecasting; includes forecasting, trending and data mining. Maintain relevant data and information into respective departmental/company systems and databases to ensure current, accurate and robust analytics and reporting. Participates in the development, education, communication, implementation and ongoing maintenance of GP analytical methodologies and models, data and reporting templates.
• Presenting Results. Presents objective insights from analyses to relevant partners up to and including CLC. Produces and disseminates routine and ad hoc reporting to ensure GP and other cross-functional partners and stakeholders are kept fully abreast of key information relating to assigned government payers and programs. Creates and implements standard and ad hoc reports.
• Level of Expertise. Responsible for updating relevant government program methodologies and keeping these current at all times. Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above j...

Job Description

The Senior Business Systems Analyst position will work in Medical Communications and is primarily responsible for but not limited to the following;

• Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change
• Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements
• Provides consultation to users in the area of business systems and processes
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis
• Facilitate strategic initiatives in Medical Communications/US Medical Affairs, as well as business partners across Roche/Genentech
• Conduct ongoing feasibility studies and gap-analysis for improvements through automation and/or business process changes
• Assist business function areas in understanding strategic problems, opportunities, and the big picture for the functions to make informed decisions to support the business long-term
• Propose strategic recommendations for process improvements and streamlining across the organization
• Articulate and communicate project portfolios alignment with overall business strategies to management and key stakeholders
• Assist management to report business health (success/achievements or areas requiring focus) 
• Liaise with IT to ensure accuracy and completeness in user requirements, functional requirements, technical specifications, process flow diagrams; may configure some system settings and/or options; also, partner with IT to drive implementation of technical solutions.
• Leads cross-functional analytical teams in the resolution of business or systems issues.
• Leads successful completion of major projects/programs across portfolios. Champions accountability by example

LOCATION:  San Francisco, CA or Rocky Mount, North Carolina

Description:  This particular position of Principle Site Manager in the North American Steriles CMO organization will have the primary responsibilities of site management of Drug Product Diluents at a Contract Manufacturer.   This role will be a position that will be the “Person in the Plant (PIP)” located in Rocky Mount, North Carolina. 

Job Responsibilities:

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as the Roche/Genentech’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, ...

This position may be filled at a Strategy Manager or Sr. Strategy Manager  level.

Strategy Manager/Senior Strategy Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

• Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share
• Conducts and synthesizes managed care markets landscape surveillance into commercial and market impact
• Provides analytic support for Government Affairs and Industry Analytics; including identification of commercial implications of legislation to support lobbying and forecasting
• Translates implications of reform and other legislation to Genentech’s go-to-market approach; including development and execution of Genentech’s Value Forum
• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives
• Reviews and assesses cross-functional business strategies, plans and tactics.  Influences decision-making regarding Commercial-wide patient access-related issues
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics.  May also be, as assigned, responsible for Reimbursement Outlook
• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans
• Works with MCCO account management teams to develop and communicate the managed care marketing strategy. Works similarly with MCCO’s field reimbursement account management teams to develop and communicate the managed care practice management strategy for physicians and other healthcare professionals in the field
•  Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.
• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners
• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments
• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives
• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
• Executes a number of strategic projects and develops internal points-of-view (POVs)
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale. Collaborate across multiple functional areas such as formulation development, manufacturing and validation. Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus: storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and/or terminal sterilization by radiation, vaporized hydrogen peroxide, or other gases. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience.

Senior Health Economist (E5)/ Principal Health Economist (E5A)

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the cardiometabolism or neuroscience therapeutic areas

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.  

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills

-Proactively collaboration with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier chapter to support launch. Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.

Description

Management Associate, U.S. Commercial Services

Reporting to the Head of U.S. Commercial Services, the Management

Associate will provide high-level administrative support to the Head and leadership team members of the U.S. Commercial Services department.

Job Description:

The Management Associate supports the assigned executive and team (as appropriate) with a variety of group administration and operational activities.

Example Duties and Responsibilities:

- Acts as the departmental "go-to-person" for general operational or administrative questions or Genentech policies U.S. Commercial Services guidelines or other inquiries. There is a strong emphasis on organization and proactive coordination of activities.  

- Complex calendar management including meeting scheduling and resolution of scheduling conflicts

- Frequent interaction and planning with executive-level assistants and their customers

- Manage, plan and execute on key project support for management team, including representing company to wide range of partners and outside vendors

- Provide general administrative and clerical support to all areas in U.S. Commercial Services, as required

- Participate, plan, coordinate and prioritize work within or across teams' in support of department projects and goals using independent judgment and initiative

- Attend and actively participate at staff level meetings as required, coordinate/publish agenda and meeting minutes

- Address problems and develop practical, thorough, and creative solutions 

- Independently create and deliver communications based on general instructions

- Generate, disseminate and maintain departmental documents and information

- Administer and contribute content for the department's communication platforms, including portals, newsletters, and announcements

- Coordinate, schedule and execute departmental off-sites, team meetings, and activities, including cross-functional meetings or events

- Manage deadlines related to business planning as well as other special projects

- Develop, implement and evaluate department work processes and procedures 

- Collaborate with Admin team to support complex projects and deadlines

- Proactively assess travel needs and plans and propose arrangements

- Coordinate, monitor and track department contracts and PO's

- Schedule candidates for open positions within the department 

- Actively participate in the on-boarding of new hires

- Exercise independent judgment and discretion of sensitive/confidential and proprietary 

information

- Actively participate in Global Pharma Procurement and Commercial activities

- Ensure compliance with Genentech policies and guidelines in all endeavor

As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

Key Accountabilities:

Assisting in the overall management,planning, evaluation and documentation of projects and studies

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

To be successful in this role, youwill have the following skills and experience:

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

The Senior/Principal Health Economist is part of the broader Oncology Medical Unit organization and provides health economics and outcomes research, modeling, reporting, and other relevant analyses, within applicable legal and regulatory guidelines, which can be used to quantify the value of Genentech products in economic or societal terms. 

The Senior/Principal Health Economist will work with multiple products and indications within the Oncology portfolio and will support cross-functional Genentech and Roche teams by recommending, developing/conducting and advising on HEOR research and modeling strategies, and by developing medical and payer value propositions, portions of product dossiers, and other scientifically-based communications. 

This team supports strategic decision-making for late-stage development and across the product lifecycle. The Senior/Principal Health Economist helps set Genentech HEOR strategies, direction, objectives, and plans for innovative, effective and efficient execution. 

The Senior/Principal Health Economist will be fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. As a manager and coach of others, the AD/PHE is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, s/he leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. The Senior/Principal Health Economist monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. ¿

Responsibilities:

Incumbents are generally expected to:

• Functional lead for HEOR activities for the molecules and indications assigned, including participation in design and conduct of studies as needed

• Set and manage to outside spend budgets for multiple projects and products, including assuring that direct reports meet budget commitments and develop financial management skills

• Manage one or more health economists or other HEOR staff, with less than half of his/her time devoted to management

• Including hiring, development and ensuring technical excellence

• Directly engaged in designing, developing and conducting HEOR studies with strategic impact for the molecules for which she/he is responsible

• Maintain strong, positive relationships with senior internal stakeholders across Genentech and Roche 

• Lead development of the vision, strategic and tactical plans, resource and budget plans, for the products and indications under his/her responsibility.  Includes establishing annual and longer-range plans, goals and objectives, and effectively aligning these with Genentech and Roche cross-functional research, development and commercial strategies and objectives.

• Lead and manage execution to ensure work is completed on-time, on-target and within-budget, with the highest levels of accuracy and relevance, and in consistent compliance with legal and regulatory guidelines, Genentech and Roche policies & procedures:

• Working collaboratively, effectively and efficiently with all internal and external customers, partners, stakeholders and influencers

• Develop and cultivate relationships with key KOLs (Key Opinion Leaders) and other thought leaders, to support HEOR strategies, plans and objectives and provide strategic, critical influence for Genentech's product pipeline and portfolio

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Utilize only approved resources and messages to meet goals and targets

The Department is currently seeking an additional Pathologist to work with five of its Pathologists to help them support (i) research scientists who discover and develop drugs for the treatment of cancer, and (ii) research scientists and clinicians who discover and develop biomarkers for pharmacodynamics and patient selection purposes in Phase I, II and III clinical trials of oncology therapeutics.

The successful candidate will be familiar with, if not expert in, the molecular, cellular, systems biology, and pathogenic mechanisms of cancer. He/she will have a strong interest in providing pathology support for drug and biomarker discovery programs in cancer, and an appreciation for the need for potential flexibility in contributing support to programs outside of oncology as the need arises.  Depending on the candidate and the availability of resources, there may be an opportunity for the individual to spend part of his or her efforts in basic and/or translational research activities that have relevance to the company’s business goals.

Regulatory Program Management 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. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

EXAMPLE 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.  Briefs teams and management, as appropriate

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups

Stays abreast of therapeutic area product development and other related business strategies and plans 

Serves as the primary PDR representative on one or more regional projects at any one point in time

Analyzes data, the regulatory environment and business objectives to recommend priorities

Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche

Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development

Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment

Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project

Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management

Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams

Provides internal teams with direction on regulatory authority interactions

Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources

Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made

Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 

Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions ...

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the immunology and infectious disease therapeutic areas.

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills.

-Proactively collaborate with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders.

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier sections to support launch.

-Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities.

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment.

• The successful candidatewill be responsible for the design, development and implementation of delivery devicesfor parenteral pharmaceutical therapeutics.  Primary technologies in-scope of the role includemanual injection systems, automated injection systems, and interfaces withpre-filled syringes and cartridges.
• Major responsibilitieswill include the development and commercialization of devices includinginterfaces with the primary container.
• This person will be atechnical expert and will provide technical leadership in the development andcommercialization of new drug-device combination products in collaboration withRoche and Genentech's engineering, scientific, and manufacturing organizations.
• He/she will provideguidance and input regarding product development and will regularly interfacewith staff and leaders in Commercial Marketing, Clinical Sciences, ContractManufacturing, Product Core Teams, Pharmaceutical Development, PackagingDevelopment, Quality and Regulatory Affairs.
• He/she will also regularlyinteract with external development partners and component suppliers, and may alsosupervise staff members.