MEDICAL DIRECTOR/MEDICAL DIRECTOR - 

RESPONSIBILITIES:

Genentech is seeking a Medical Director with clinical and drug
development experience within our Development-Immunology organization. This individual will be responsible for strategic clinical
oversight with a focus on our scleroderma portfolio. The position will involve clinical development of novel agents. The Medical Director will be responsible for the design, implementation,
monitoring, analysis, and reporting of studies conducted within one or more programs.
They will also participate in developing the long-range strategic plans for the molecule or molecules.

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

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

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

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

Purpose

To provide relevant, balanced, and timely evidence-based clinical information on Genentech products to managed care customers that make decision regarding drug coverage and reimbursement, .

Description

The Associate Scientist or Scientist for Managed Care Medical Communications (MCMC) is able to communicate relevant and timely clinical information on our marketed products and compounds in late development.  More specifically, this position is responsible for communicating effectively with external customers involved in evidence-based healthcare decisions including but not limited to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities.  The MCMC Associate Scientist/Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers.  More specifically, an understanding of the comparative effectiveness research (CER) and health technology assessment (HTA) landscape is required, as well as the ability to review, assess and synthesize CER, health outcomes research and pharmacoeconomic evidence.  Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).  This position is also involved in the review of promotional marketing materials intended for the managed markets and payor environment.  The MCMC Associate Scientist/Scientist shall effectively, appropriately, and responsibly use resources to support the use and access of our marketed products.  

The MCMC Associate Scientist/Scientist may contribute to departmental efforts to develop, implement or further improve business processes and operations.  This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, writing policies and procedures.  Some business travel is expected.

Candidates should have a sound understanding of legal and regulatory topics to adequately describe the basis of Medical Communications (MC) policies and practice.  He/she must work effectively with members of the MCMC/MC staff and other internal customers that include but are not limited to: Medical Directors, Health Economics and Outcomes Research, Managed Care Liaisons, Project and Execution Managers, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaisons, Sales, Marketing, Access Solutions Reimbursement, and Corporate Partners.  This position shall partner with these entities to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products.

Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use.

DESCRIPTION:

The Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use. Ableto evaluate medical literature as well as write, review, edit, and approvemedical content to ensure appropriate clinical context and accuracy. Providesmedical responses through various communication channels (response documents,web-based media, scientific meetings, etc.). Is also able to provide trainingrelevant to Genentech's product portfolio. Has a basic understanding oflegal/regulatory topics adequate to describe the basis of Medical Affairspolicies and procedures, and applies this knowledge to the review ofpromotional materials and Medical Affairs documents.  The Medical Communications Scientist is able to assist in the development andimplementation of Medical Communication policies and procedures, establish andsupervise the work flow for delegated projects, and assess incoming requestinformation to determine required action and triage based on internal policiesand procedures. Can convey and acquire medical information as well ascommunicate and work effectively with members of the Medical Communicationsstaff and customers which include but are not limited to: Sales, Marketing,Managed Care, Clinical Development, Product Safety, Regulatory, Legal, andCorporate Partners.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• General Duties: Master Level PM and Repairs of process equipment and systems such as Fermentors, Centrifuges, Mixers, Autoclaves, Washers, Pumps, Agitators, Mechanical Seals, Control Valves, Steam, Hydraulics, Pneumatics, Electrical Controls, Chilled Water, High Purity Water, Compressed gases etc.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

The Analytics Manager/Sr. Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective quantitative data analyses to address critical business issues and to support strategic decision making for the company.  The Analytics Manager will utilize advanced analytical techniques to: 1) Increase understanding of effectiveness/ROI of all promotional efforts including sales force; 2) Mine and analyze longitudinal patient-level data to generate hypotheses for brand teams and to inform primary market research; and 3) Measure the impact of business unit and multi-product initiatives on product specific performance.  The Analytics Manager/Sr. Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with MA&S and Brand team colleagues to understand business objectives and to apply analytics for marketing projects.  The Analytics Manager/Sr. Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.  He/she utilizes SAS and advanced statistical techniques to:

MAJOR RESPONSIBILITIES:

1. Develop and implement standard ROI principles and analyses and present results to marketing teams (20%)
2. Develop and implement analyses for field force promotion, including customer segmentation, targeting, and promotional response measurements (20%)
3. Make recommendations to brands and other stakeholders on the effectiveness of different marketing tactics (10%)
4. Generalize approach to measuring common programs across the business unit (10%)
5. Establish and maintain data and approaches to measuring tactic interactions and cross-product impact (10%)
6. Partner effectively and collaborate with other MA&S colleagues to provide holistic analytical insight (10%)
7. Develop Marketing Mix models to optimize marketing spends. Create process for effective monitoring and decision making of marketing spends (10%)
8. Represent brand-specific MS approaches and customizations to the broader team to ensure consistency in MS across the portfolio; learn from others, and proactively share and seek out advice on approaches to complex MS situations (10%)

Join a Biotechnology Leader
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions.

Our founders believed that hiring talented, enthusiastic people would make Genentech a success. Today, we still believe our employees are our most important asset. For this reason, we aim to provide employees with a stimulating and collaborative environment where they can make important contributions to medicine and thrive as professionals.

THE POSITION:

The Senior / Market Planning Manager participates actively in Genentech’s commercial planning efforts by providing unbiased, objective, in-depth information on current and future markets, product performance, customers and competitors. He or she has first-line accountability for Market Planning contributions to commercial and cross-functional teams, management of team relationships, and provision of information and recommendations to stakeholders.  Additionally, the Senior / Market Planning Manager identifies critical business issues and opportunities for growth, collaborates with Genentech teams, and works to embed an external market point-of view into the strategic direction of the company. He or she also supports product launch or line extension activities and helps the organization make optimal decisions regarding the lifecycle of the product.

MAJOR RESPONSIBILITIES:

• Evaluate the market landscape, monitor changes and predict trends in market dynamics and competition.
• Provide an objective market viewpoint based on an in-depth understanding and analysis of customer and environmental information. Provide recommendations on marketing strategies and tactic effectiveness.
• Create, validate and refine patient-based, long-range forecasts for product. Communicate revenue information throughout the organization.
• Act as an internal consultant to stakeholders across marketing, sales, managed care marketing, clinical, regulatory, finance, manufacturing, and other functions, to support strategic decision making and help maximize Genentech's commercial success.
• Partner with other brand teams across Market Analysis & Strategy and other Commercial Operations functions to provide a holistic analytical viewpoint to the brand teams.
• Effectively employ primary market research and leverage secondary data to accomplish the above.
• Contribute to the success of the department by leading cross-departmental projects.
• Potentially mange and develop one or more direct reports.

CAPABILITIES:

• Strong command of a variety of analytical and market research techniques, sought out as an analytical expert and, more importantly, as a strategic advisor. Grasps key issues quickly, understands the "big picture" and links market insights to larger issues.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.  Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers.  Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches that may fall outside historical norms.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to "tease out" information required for decision-making. Can handle risk and uncertainty.
• Ability to represent the Market Planning function on commercial and cross-functional teams. Can negotiate skillfully in tough situations with partners and customers.
• Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around, and influential with, higher management.
• Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• Operate systems that clean and sterilize tanks and filtration systems. 

• Prepare solutions for the production process.

• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).

• Trouble shoot equipment and process problems.

• Comply with safety requirements, cGMP, SOP and manufacturing documentation.

• Use of automation to perform production operations.

• Provide support to Manufacturing to meet production demands.

• Operate automated systems for equipment operation.

• Assemble and prepare equipment for production.

• Exhibit detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Exhibit professional interpersonal skills.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.

• Operate and clean fixed tank and filtration systems.

• Operate large scale column chromatography systems.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

• Cell Culture Manufacturing (CCM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations.
• Purification Operations Group (POG): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems.
• Centralized Manufacturing Services (CMS): Provide support to Manufacturing and Quality Control to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials;  Provide quality materials and service to our customers.

Job Responsibilities:

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
  

• Assesses existing learning & development curricula and offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May develop, manage or individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; enabling self, team, department and overall function with detailed partner/stakeholder input
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, specific programs and/or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development support
• Works with others to develop and implement an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate team's offerings and support strategies
• Works with others to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or other
• Works with manager and peers, and oversees team in such a way as to, continuously assess and evaluate learning & development plans and activities to ensure continuous, strategic alignment to meet or exceed internal business partner and other stakeholder needs and objectives
• Consistently monitors and supports team's work and associated work output. Regularly coaches, advises and gives further direction to help team members fine-tune and hone their work to meet or exceed assigned goals and objectives
• Ensures self and team members, where and when appropriate, seek regular internal client or other partner/stakeholder input into in-development work; does so to ensure maximum alignment to internal client needs, objectives and goals
• Consistently oversees the execution/implementation of team's work to ensure timely and best quality output. Manages similarly with any applicable external partners; ensuring their work is on-time, on-target and within-budget to meet or exceed assigned goals, objectives and other expectations
• Hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

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...

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.

Lead cross functional project teams to:

- Deliver project goals on budget and on schedule
- Develop customer requirements into an approved project charter
- Analyze business, process and systems performance, and identify improvement opportunities
- Make recommendations to Management based on business case and analyses
- Lead decision making support and make recommendations regarding best options
- Communicate proactively with stakeholders regarding progress, issues and plans for resolution
- Develop and use project plans to coordinate participants and track and report progress
- Ensure improvement methodology and tools are utilized effectively to maximize benefits
- Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

Competencies:

Job Knowledge and Scope – Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments (defines scope and approach). Occasionally creates course material and delivers advanced lectures to internal and external audiences.

- Collaborative Leadership – Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.

- Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly. Asks “what can I do to help?”.

- Communication – Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.

- Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt.   Able to synthesize large amount of information.  Able to deliver results despite shifting environment.

- Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.

- Customer focused – Partners with customers, looks ahead to predict future customer needs. Manages expectations.
- Supervision – Work is performed under limited direction. Establishes own work priorities and timelines. May provide guidance and coordinate work activities of other personnel.

- Job Complexity & Decision-making – Develops solutions to a variety of complex problems and initiatives. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact.

- Interaction – Interacts with senior internal and external personnel on significant matters. Represents the organization as a prime contact on initiatives and projects.  Can facilitate RCA's, lessons learned, K-T analyses and FMEA's.  Can facilitate strategic discussions with leadership teams.

• Primarily accountable for ensuring the technicalsuccess of the maintenance  operations and the performance management of aworld-class maintenance  organizational unit associated with thecommercial manufacture of all GMP products.  
• Manage activities of designated functional unit inmaintenance  shift or unit supervisors/leads who direct daily activities.  
• Identify the technical, procedural andequipment issues that may compromise production and compliance, working closelywith cross-functional groups to identify and implement solutions.
• Manage and resolve technical andcompliance issues with Quality, Manufacturing, Manufacturing Sciences andTechnology, Reliability Engineering, Engineering, & EH&S.
• Develop weekly and monthly goals andschedules and set priorities for supervisors/leads. Evaluatesupervisors’/lead’s performance; ensure supervisors’/lead’s fair and timelyevaluation of the performance of their staff.
• Responsible for identifying andimplementing improvements in staff development in areas such as cGMP training,technical skills, safety, performance management.
• Implement and follow through oncorrective and preventative actions for variances.
• Represent the department in reviewingand approving all maintenance related documentation requiring approval such asprocess validation protocols and final reports, planned and unplanned variancereports, documentation change requests, engineering and facility changerequests, and validation protocols.
• Ensure that all operations areperformed with 100% compliance to documentation cGMP standards.
• May prepare department budgets andstrategic staffing plans.
• Assist Associate Director with settingbusiness goals and cross-functional deliverables.
• All employees with jobs that requireaccess to the Warehouse must be able to pass the Transportation SecurityAdministration (TSA) Security Threat Assessment (STA).
• Promotes a safety culture that supportcontinuous improvement in the EHS management system through activecommunication and functional area participation in site safety teams ensuringthe safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt.
• Manage assignments that are complex innature where independent action and a high degree of initiative are required inresolving problems and developing recommendations.
• Manage problems where analysis ofsituations and data requires an evaluation of intangible variables.  
• Exercisesindependent judgment in developing methods, techniques and evaluation criteriafor obtaining results.

The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for upstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as USFL representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in two areas;

·         Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·         Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.