Specific opportunities available in the following areas:  Personalize Healthcare & Companion Diagnostics; Commercial Assessments; Health Information and Technology (HIT) & Industry Intelligence; Managed Markets Analytics

Industry Analytics participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues related to access, reimbursement, and managed care influence.  Leveraging strong structured problem solving skills and collaborating with partners in Market Analysis & Strategy (MA&S), Managed Care & Customer Operations (MCCO), Government Affairs (GA), and Commercial brand teams, the Industry Analytics (IA) team translates market phenomena into unbiased, astute, and actionable insights, and creates innovative analytical solutions in support of key business objectives and decisions.   

• Provide an objective commercial viewpoint based on in-depth understanding, analysis, and synthesis of qualitative and quantitative primary and secondary information.  Assess the market impact of policy, regulatory, and development trends affecting GNE’s portfolio, including current or emerging trends.
• Navigate a complex internal set of teams and functional groups addressing the future landscape and impact, and have an appreciation for the nuanced role that Industry Analytics plays in this effort.
• Navigate a high degree of uncertainty while effectively communicating a point of view and best estimate for planning purposes.   Comfort with ambiguity and can act without having the total picture; able to effectively pose questions in order to "tease out" information required for decision-making.
• Collaborate with Market Planning, Brand Teams, Government Affairs, Medical Affairs, Regulatory, Legal and Global partners in order to inform and model assumptions, communicate impact, influence risk mitigation strategies, and support company initiatives and messaging on strategy.
  
• Successfully identify appropriate opportunities to employ secondary and primary market research techniques to accomplish the above. Guide and conduct primary market research as needed to inform key assumptions critical to good decision-making.  Have sound knowledge of the strengths and limitations of secondary data.
• Successfully employ structured problem solving and quantitative modeling techniques as required to inform key business questions.

Project Manager – IT (Genentech – South San Francisco)

The MCCO Solutions team in IT Americas is looking for a motivated Project Manager to lead the delivery of technology projects in support of US Commercial Operations. The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of the project management methodology. The PM will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This PM position will be accountable for projects in the MCCO Solutions group for the Commercial Customer Operations portfolio.

Duties:

* Define, plan, and lead the execution of technical implementation projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology vendors/partners and business stakeholders to achieve project objectives

* Establish and maintain effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Suggest process improvements where appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Other duties as assigned

We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.

We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.

We are seeking a highly motivated individuals to join the Oncology Biomarker Development Dept. to lead companion diagnostic (CDx) development programs in support of the Roche / Genentech early and late stage Oncology clinical development pipeline. The incumbent will provide leadership for a portfolio of molecules within a Franchise and represent these programs to senior management and decision-making bodies internally.

The CDx development strategies will be closely aligned with clinical development program timeline and strategy to enable robust clinical validation of the CDx, including establishment of thresholds and statistical analysis of the relationship with efficacy or safety using robust assays developed with diagnostic partners. The incumbent will also develop cross- functional relationships with internal scientific, operational and regulatory groups and diagnostic partners, and represent GNE / Roche CDx efforts to external professional organizations and regulatory bodies. The successful candidate will also be expected to contribute to Medical Affairs strategies to enable biomarker hypothesis testing.

Responsibilities

• Work closely with the biomarker, regulatory, statistics and clinical leadership to ensure development and effective operational execution of the CDx portfolio of multiple investigational agents in Franchises or Disease Area
• Management of direct and matrixed reports whose responsibilities will include programs in both early and late stage clinical development. A substantial focus will be in early development where design of CDx strategies that enable device development in preparation for hypothesis testing will be important. Therefore requires strong understanding and experience with development of diagnostic devices in order to develop fit for purpose CDx strategies.
• Develop and lead strategic initiatives to identify novel CDx technologies and develop relationships to enable effective evaluation of technologies as CDx assays.
• Develop and lead IVD strategies that are aligned with disease areas including development of multiplex platforms to support investigational and approved products in collaboration with diagnostic partners.
• Enable the coordination and execution of exploratory biomarker hypothesis testing in the clinic.
• Develop relationships with external key investigators, scientists and professional organisations in the diagnostic technology field to inform internal CDx strategies including next generation technology implementation and validation.
• Represent CDx strategy to health agencies as part of the regulatory strategies for the agents within the entire portfolio.

• Participates in site and/or regional and/or global PDR Program Management departmental meetings
• Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough ¿and compliant execution
• As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, ¿communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. 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
• Stays abreast of therapeutic area product development and other related business strategies and plans
• Supports on one or more regional projects at any one point in time 
• Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
• Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
• Documents meetings, teleconferences and other interactions/communications with regulatory authorities
• Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority ¿interactions
• Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory ¿deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting ¿minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
• Helps manage project plan...

• Development of new in vivo models of autoimmune, inflammatory, and infectious diseases that reproduce significant aspects of human pathophysiology, as reflected, in part, by response to human standard of care therapeutics or their surrogates.
• Generation of new assays in preclinical species to ascertain and understand PKPD relationships of specific new molecular entities (NME), as well for the performance of efficacy experiments with NMEs in appropriate models.
• Interaction with discovery laboratories in which the NMEs are generated in order to design and execute appropriate experiments to characterize the NMEs and their effects, as well as to develop technologies required for the pursuit of the scientific objectives of the discovery laboratories and of Translational Immunology.
• Translational Immunology representation on NME teams. These roles will be performed both in his/her own laboratory and by oversight of three additional laboratories.

 Purpose: 

The Genentech Research and Early Development (gRED) Clinical Program Leader (CPL) position is accountable for operational strategy for assigned early development programs. The CPL is accountable for functional management including recruiting, building and maintaining a high quality gRED Clinical Operations organization. 

Primary Accountabilities and Responsibilities: 

Program Management Responsibilities: 

Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech’s early development portfolio: 

• Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) 

• Develop program timelines and budgets and manage variance 

• Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans 

• Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget 

• Develop and present operational plan to management review bodies 

• Identify program risks and develop and implement mitigation strategies for assigned programs 

• Define the resourcing and outsourcing strategy for early development programs 

• May participate in Business Development assessments 

• Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders 

• Partner with Business Management to identify strategic business needs to support the clinical programs 

• Partner with late-stage development leaders to ensure strategic alignment on the CDP 

Functional Management Responsibilities: 

Identify, recruit, hire, and develop Clinical Operations staff, as well as oversee their work to ensure all department goals, deliverables, and objectives are met. Additionally, contribute to the Clinical Operations organization. These responsibilities include: 

• Manage Clinical Operations staff including development, coaching, mentoring, performance management, and succession planning 

• Ensure that employees are appropriately trained and comply with company and regulatory standards 

• Create a positive work environment by encouraging mutual respect, innovation and accountability 

• Resource projects to enable teams to meet deliverables 

• Create and maintain Clinical Operations as a ‘great place to work’ 

• Participate in and/or lead working groups and/or initiatives within the gRED organization or cross functionally as required 

• Partner with Process and Training Management (PTM) to optimize and continually improve processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs 

• Create an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel *LI-EK1

• Perform business analysis activities to design, develop, and deploy solutions including projects, enhancements and upgrades for internal customers
• Analyze data processing problems related to gRED information and planning systems including the Planisware solution and the gRED portfolio analytics platform
• Lead and facilitate meetings with Director and VP level customers to determine organizational needs and requirements and develop solutions
• Manage 2–3 major projects of diverse scope across functional areas
• Create and/or assist with required project documentation practices such as user requirements, functional specifications and service level agreements
• Resolve technical and process incidents and problems according to Service Level Agreements
• Collaborate with internal support teams and external vendors to ensure and continuously improve system stability and optimal performance for deployed solutions

Sr. Manager, Promotional Services

Location:  San Francisco, CA

Job Description

1. Compliance, Knowledge & Skills

o Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these

o Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals

o Asks questions when in doubt

o Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct

o Where applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2.  Team Leadership & Development

o Sets short and long term goals, vision and strategy for the team

o Plans & implements an aligned team structure with clear roles & responsibilities and ensures the appointment/placement of appropriately skilled/qualified team members to meet the different needs/roles within the team

o Hires, develops and retains talent on the team; ensuring alignment of hiring in relation to team structure requirements to help fulfill/meet departmental plans and objectives both in the immediate sense and over time/building for the future

o Ensures direct reports are developed to expand their skills and abilities, as well as relevant product and surrounding marketplace knowledge

o Proactively manages team performance, giving direct, clear, open & honest feedback, as well as recognizing and rewarding successes. Ensures any indirect reports are also regularly appraised of performance feedback. Complies, and ensures the same for any indirect reports, with all company policies & procedures in terms of formal performance feedback & reviews

o Acts rapidly, appropriately, decisively and consistently in cases of observed or reported potential policy violations. Is guided by company policies and procedures

o Ensures team members have access to needed resources and information that will enable them to perform their roles/responsibilities to the best of their abilities. 

o Provides direction, coaching, feedback and guidance to help ensure the team meets or exceeds assigned goals and objectives

o Leads by example in developing personal technical and leadership skills and ensures team members participate in similar opportunities

3.  Planning & Development

o Ensures team and self stay abreast of internal and external changes and evolutions: Genentech business strategies, goals and objectives, market and industry trends, as well as legal and regulatory developments and requirements

o Works with direct reports, brand teams across all Genentech Commercial business units, and external advertising agencies to proactively review and plan for upcoming promotional communication strategy requirements:

* Assigns team member responsibilities by Genentech business unit and/or Genentech brands

* Contributes to strategies around scope, content, order volume, artwork, quality, compliance and other project management direction, requirements and terms

* Plays a leadership role in managing external vendor selection process and programs

* Develops key content for all RFP documentation, including detailed requirements for promotional services as well as process for competitive bidding and selection

* Takes the lead departmental role in identifying and recommending opportunities to optimize their investment

* Ensures the team is meeting the needs of the commercial organization

o Responsible for ensuring streamlined departmental practices, procedures, systems and tools:

* Defines internal workflows and processes; includes development and implementation of DOPs (Department Operating Procedures) 

* Defines all roles and responsibilities across team

* Identifies, recommends and oversees the development of departmental systems and tracking tools, such as digital asset management system, gPrint, etc.

* Defines departmental performance metrics and standards, such as key performance indicators that enable the department and its internal customers to measure effectiveness and efficiencies

o Analyzes and makes recommendations regarding workload balance and required resources and other infrastructure needs to fulfill all project management responsibilities, goals and objectives across all Genentech business units

o Identifies, leads and/or assigns special, other departmental projects, as and when appropriate

o Leads the discovery process of new innovative solutions to the stakeholders that the team will take on as a priority 

4. Project Management & Operations

* Acts as lead industry expert for promotional communications stra...

• The Senior Regulatory Global Project Manager is expected to serve as a strategic partner with Global Regulatory Leaders (GRLs), work with the GRL and the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions;
• Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team;
• Contributes to the efforts of building templates, tools and processes to optimize filing team performance;
• Serves as business partner for the assigned TA (Therapeutic Area) in PDR, working closely with the TA Head, brings excellent project management service offering to the TAs, and also bring TAs’ request/feedback to the Regulatory Business Excellent (RBE) to help further optimize the performance and service offering by RBE.

• Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need;
• Takes accountability for all project management aspects and works effectively and closely with the GRL or Team Leader;
• Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team’s activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources;
• Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders;
• Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PTS of a filing, and work with team to define a mitigation plan;    
• Effectively facilitates filing team meetings with high quality meeting agenda and minutes;
• Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items;
• Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines;
• Maintains proper online documentations of filing related project documents;
• Assists GRL on preparation, organizing and conducting lessons learned sessions post filing;
• Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO’s project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.

Manage selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Ensure effective training program exists, improve with time, and are managed in compliance with PQS
• Ensure all employees have developmental goals and barriers removed to support attainment of goals
• Drive continuous improvement initiatives which simplify processes, enabling improvement in right-firtst-time, and appropriate prioritization of high compliance risks
• Manage and prioritize resources through IMPACT and in alignment with associated IMPACT prioritization priciples
• Ensure projects and initiatives are completed on time and within budget.
• Collaborate, influence and/or author department policies and procedures.
• At the cross-site and corporate level, provide leadership, vision and direction to:
­ address complex validation issues and influence network direction
­ develop and maintain validation programs  within cGMP regulations and the PQS.
• Monitor and control expenditures against the department budget.
• Immediately escalate potential quality or regulatory issues that may impact product quality or regulatory compliance.

Technical Duties/Responsibilities:
• Provide direction to subordinates in order to provide effective oversight of all validation systems lifecycle deliverables, per PQS.
• Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.
• Ensure that the Quality Leadership Team is aware of significant validation issues that may impact product quality or operations.
• Maintain and present validation systems health, representing the health of the program.
• Serve as technical and strategic resource for a range of validation assignments.
• Review and approve regulatory submissions and present validations to regulatory authorities during routine and pre-approval inspections.

Responsibilities:  A postdoctoral position is available to study oncogenic pathways in breast cancer.  Strong molecular and cellular biology skills are required. The successful candidate should have familiarity with mutagenesis, RNAi, signal transduction, and protein characterization. Candidates with a strong background in protein structure and function will also be considered. A practical working knowledge of bioinformatics analysis would be desirable.  The successful candidate will be required to work in a highly collaborative and multi-disciplinary environment. See recent publications: Cancer Cell 20:472 (2011); Cancer Cell 15:429 (2009); Cancer Res 68:9280 (2008).

We are seeking a candidate for a postdoctoral position in the Department of Molecular Biology, to investigate vascular processes.  Research topics include Notch, BMP, Tie2 and EphB4 signaling pathways, and roles of microRNAs in vascular biology.

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...