The Position

The IT Project Management position in the Patient & Physician Solutions team will be responsible for leading the delivery of technology projects in support of the Access Solutions in the US, which provides services to help people get access to Genentech medicines for a range of serious conditions.  The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path. The IT Project Manager will be responsible for supervising work by the assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The IT Project Manager will be accountable for projects in the Patient and Physician portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers.

Primary Responsibilities:

• Define, plan, and direct the execution of technical projects, balancing the competing demands of scope, time, cost, quality, resources, and risk
• Identify, acquire, and lead multifunctional project teams
• Manage multiple projects, in addition to individual projects assigned to the position
• Ensure project objectives/requirements are clear and agreed to by all stakeholders
• Manage relationships with various technology and business communities to achieve project objectives
• Facilitate project management activities across the entire project management methodology
• Establishes and maintains 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
• Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet relevant Computer System Validation directives
• Suggest improvements where necessary / appropriate to improve operational efficiencies
• Conduct risk management planning, identification, analysis and monitoring on projects
• Formulate risk mitigation strategies and recommend solutions
• Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems
• Assign and supervise project activities to the team leads and team members.  Communicate and coordinate assignment and resource-related issues to Genentech management and resource vendor representatives.
• Other duties as assigned

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

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

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

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

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

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

RESPONSIBILITIES INCLUDE:

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

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

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

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

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

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

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

ABILITIES:

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

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

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

The 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%)

Description

Management Associate, U.S. Commercial Services

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

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

Job Description:

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

Example Duties and Responsibilities:

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

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

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

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

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

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

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

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

- Independently create and deliver communications based on general instructions

- Generate, disseminate and maintain departmental documents and information

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

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

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

- Develop, implement and evaluate department work processes and procedures 

- Collaborate with Admin team to support complex projects and deadlines

- Proactively assess travel needs and plans and propose arrangements

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

- Schedule candidates for open positions within the department 

- Actively participate in the on-boarding of new hires

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

information

- Actively participate in Global Pharma Procurement and Commercial activities

- Ensure compliance with Genentech policies and guidelines in all endeavor

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

Key Accountabilities:

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

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

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

•  Interactions with health authoritiesand expert bodies

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

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

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

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

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

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

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

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

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

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

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

Responsibilities:

Incumbents are generally expected to:

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

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

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

• Including hiring, development and ensuring technical excellence

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

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

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

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

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

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

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

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

RESPONSIBILITIES INCLUDE:

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

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

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

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

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

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

-Manage budgets, timelines and deliverables as planned.

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

ABILITIES:

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

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

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

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

EXAMPLE DUTIES AND RESPONSIBILITIES:

Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate

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

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

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

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

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

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

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

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

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

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

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

Provides internal teams with direction on regulatory authority interactions

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

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

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

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

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

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

Senior Business Systems Analyst 

The Senior Business Systems Analyst will be responsible for supporting Strategic Pricing and Contracting Management (SPCM) systems planning and business process support, including contract development, contract administration and government price reporting operations. This role supports alignment of business processes and systems to provide accurate business monitoring, analytics and operational excellence across SPCM Teams.

The Senior Business Systems Analyst will be responsible for providing leadership on system projects including data analysis, user requirement gathering and documentation, business process documentation, and impact and gap analysis. They will serve as the subject matter expert for contract development, contract administration and government price reporting business processes, and the Veritas applications.

The Senior Business Systems Analyst will need to develop an understanding of the complex data environment in order to enhance standard reports, perform analysis and develop ad hoc queries and reports. This position requires the ability to retrieve data from multiple environments, identify trends, perform analysis and make recommendations. They may also lead or participate in developing data management strategies (including MCCO IT initiatives such as with the Channel, Customer and Contracting Performance, C3PI Initiative) and implementing accurate infrastructure for robust and hight-accuracy analytics. The position also requires strong written and verbal communication skills and an ability to collaborate with management and other functional groups within the Commercial organization. The data analysis will also support the SPCM Operational Excellence program that will be driven by existing and new metrics.

This position will be expected to have an up-to-date knowledge of the enterprise IT strategic direction and be able to influence IT system decisions that will be cost-effective, supportable and scalable. This will require strong leadership on projects and in the prioritization of the overall project portfolio, developing business cases and driving to maximize sIT ROI. This position reports to the Group Manager, Strategic Pricing and Contract Process and Technology.