Statistical Programmer (SPA-2) 

Position Purpose:

The Statistical Programmer has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations.  He/she supports statistical programming teams on assigned study level activities in planning, designing, and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.     

Major Responsibilities and Accountabilities:

 Contributes to SPA team in preparing summarized information to clinical study team members

 Assist statistical programming activities at study level or components of a clinical project as applicable

 Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision

 Under guidance of a senior SPA, develops approaches to meet the study and project requirements

 Assist in determining and developing approach to technical solutions

 Responsible for accuracy and reliability of results.  Builds and monitors quality in every aspect of job activities. 

 Has an awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables

 Is aware of timelines and scope based on resourcing / priority constraints within the SPA team and understand their implications on individual work assignments 

 Builds and maintains effective working relationships with SPA team members.

 Adapts to changing circumstances, policies, work assignments, and/or team members.  Able to multi-task and prioritize between tasks

Level:
Automation Engineer I (E2)

Genentech's US Biologics Pharma Technical Development organization is looking for an Engineer I to work in our Process Development Engineering group (PDE).  PDE's role is to provide innovative engineering services to the cell culture and purification pilot plants and labs.  PDE also evaluates new automation, robotics, and process sensor solutions for Drug Substance processing.

The Automation Engineer will be expected to support the users and systems in the large scale cell culture pilot plant.  This role will require design, specification, implementation and maintenance of bioreactor control systems for both mammalian and microbial processes.  Key roles and responsibilities include:

-  Identification, evaluation and implementation of new technologies to improve the efficiency and safety of control systems at Genentech.

-  Maintenance and troubleshooting of hardware and software on the process control systems in the Process R&D Labs and pilot plants.

-  Design, implementation and support of laboratory automation systems.

-  Leading and supporting small project teams which design develop and integrate automation systems in the Process R&D laboratory and pilot plants.

-  Scope of work definition and supervision of contract labor for small and medium projects under the direction of a senior engineer.

-  Collaboration with Corporate Engineering, Manufacturing Science and Technology (MSAT) and other business partner groups on technology transfers and information exchanges.

-  Author and maintain system support and specification documentation.

-  Author technical reports and/or presentations.

-  24/7 on-call support is required for this position.

This IT Manager is responsible for managing the Portfolio processes for Research and Development IT and for providing Project Management on a variety of projects that are used by Research and Early Development.  The position also oversees Portfolio/Project Management, Budgeting, Forecasting and related processes for Research and Development IT.  The position is part of the gRED IT organization.

Responsibilities: 

• Acts as Project Manager on projects, as assigned.
• Ensures that formal project management processes (PMM) are adhered to 
• for planning, chartering, and management of strategic initiatives and 
• projects. 
• Establishes and manages project teams and core teams to develop and 
• execute project plans. 
• Monitors projects and their progress towards goals, provides status, and 
• ensures issue resolution. Manages project budget and timeline to ensure 
• that they are efficiently delivered.
• Identify and implement process improvements in solution delivery and 
• support of new and existing solutions
• Collaborates with Pharma Informatics technology groups and business 
• functional groups, to ensure project delivery and on-going support of 
• applications.
• As the Portfolio Manager for gRED IT, partners and coordinates with Finance, gRED IT project managers and functional managers, other Portfolio Managers and the business to ensure appropriate project methodologies, governance and control processes are followed.  Also coordinates annual budgeting and monthly forecast/actuals processes and acts as the gRED IT representative on larger Pharma IT portfolio process improvement efforts.  Provides support and guidance to gRED IT project managers, as needed.
• Coordinates the yearly and project budget processes, including monthly forecasting, actuals analysis and resource management processes for your area of responsibility. 
• Provides support to the Director of gRED IT, as needed, related to creating general presentations, leading certain recurring meetings, etc.
• Participates in the Leadership Team of gRED IT organization

In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs.  This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products.  The successful candidate must have demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork and communication.  He/She will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. The successful candidate must have an ability to develop and drive innovative solutions to complex regulatory strategies while maintaining compliance with regulations.  With a focus on biologics marketed products, he/she will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.  Additionally, he/she will support departmental business processes to document and improve best practices and work efficiencies.

He/she will be responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. He/she will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

TheImmunology, Tissue Growth and Repair Diagnostic Discovery Department is seekinga motivated, interactive and flexible Senior Research Associate to perform researchrelated to biomarker discovery and analysis in infectious diseases. 

Theposition will report to a Scientist lead for the Department's new program inInfectious Disease and Host-Pathogen responses. The successful candidate willimplement a variety of in vitro and in vivo molecular, proteomic and cellulartechniques to elucidate disease pathways and identify relevant biomarkers, andwill be expected to make intellectual as well as technical contributions to theteam. Responsibilities: Perform wet lab experiments, generate and analyze dataand communicate findings and interpretations relevant to the Department'smission to identify predictive and prognostic biomarkers for therapeuticResearch and Development programs. Specific responsibilities will include:performing exploratory disease-oriented research utilizing samples & datafrom human infectious disease cohorts, processing and analyzing clinical trialsamples, data analysis and presentation, and contributing to experimentaldesign/planning.

The successful candidate will be a key member of the Cross-Portfolio Governance (CPG) team within PPP/Pharma Portfolio Management. The CPG team establishes and manages governance operations and decision-making processes for late stage development to enable well informed and timely corporate decisions on portfolio investment and prioritization.

The manager of LSPC Operations works in close partnership with the late stage portfolio committee (LSPC) Business Manager and is responsible for providing project management support for CPG key initiatives and for leading and managing the monthly LSPC decision-making operations cycle.

Responsibilities

• Lead and manage the monthly LSPC agenda preparation process with key stakeholders in late stage teams in efficient, collaborative and transparent way
• Write minutes for the LSPC monthly meetings
• Anticipate, identify, manage and communicate risks to the execution of the monthly operations cycle
• Support LSPC Business Manager in preparing recommendations and proposals for meetings with LSPC Chairs and other senior leadership
• Maintain LSPC Charter, process documentation and required templates for team presentations for committee decisions
• Manage CPG communications with cross-functional stakeholders
• Guide, educate and support late stage teams, finance, PPM and other key stakeholders though the LSPC operational processes
• Actively contribute to best practices and continuous improvement
• Provide project management support to key projects, and programs led by CPG members and sponsored by senior leadership

Job Skills and Expectations

• Excellent project management skills
• A strong understanding of pharmaceutical/biotech industry, drug development process and trends, and business strategy
• Customer service orientation and attention to detail
• Strong oral and written communication skills
• Experience managing process improvement implementation and change
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.

Global Product Development Biometrics Biostatistics (PDBB) at Roche/Genentech plays a key role in successful drug development by contributing expertise to the drug development process from research through entry into humans through regulatory approval and beyond. Biostatisticians collaborate on cross-functional teams with colleagues from Clinical Science, Safety Science, Regulatory Affairs, and other functions.  Statistical Methods and Research is a group of statisticians within PDBB with a mission to enhance our strategic and methodological capabilities. Current areas include portfolio decision-making, quantitative benefit-risk, regulatory statistics, and personalized healthcare, but may be extended to meet business needs.  

Key responsibilities include:

• Provide effective, timely and reliable consultancy across the company on statistical problems

• Engage in research in statistics to improve clinical trial methodology used in the development of company products consistent with corporate priorities and timelines

• Work in collaboration with Biostatistics leadership to identify and prioritize areas of potential impact that need new or improved statistical methods

• Impact drug development science beyond the company in industry forums

• Influence internal and external stakeholders to produce and implement robust drug development strategies 

• Contribute to ensure that PDBB is regarded as highly effective strategic partners in drug development whose prestige extends beyond the company

• Develop and maintain expertise in at least one core area of biostatistics and serve as an advisor to other biostatisticians and PD leadership

Job Summary:

Perform analytical, biochemical testing and related activities to support QC operations

Description:

Must have flexible schedule, 4x10 day shift schedule. This role will require working major holidays.

Perform analytical, biochemical, and/or biological cell based testing of commercial and clinical in-process, drug substance, drug product and stability samples to meet standard lead times to support Quality Control Bioanalytical  / In-Process operations. 

Technical Duties/Responsibilities:
•Perform testing of routine and non-routine samples (e.g. Spectrophotometry, pH, HPLC) and document according to GMP.
•Review data and assess against established acceptance criteria
•Perform technical review of peer-generated data for basic methods
•Prepare data tables and graphs
•Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
•Receive and provide training
•Participate in assay transfer and assay validation.
•Perform equipment qualification / maintenance
•Prepare and maintain standards, controls, stocks, and cultures per established procedures
•Support the maintenance and compliance of operational areas.
•Assure and apply GMP throughout operations.
•Coordinate with customers to support operational activities.
•Support internal and external audits.
•Work to meet schedules.
•Identify and support resolution of technical problems.
•Actively participate in group and project teamwork; project and process improvements.
•Drafts protocols and reports under supervision.
•Meets scheduled performance of 95% on time.
•Perform other duties as requested by managers to support Quality activities.

Note:
•Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
•Must be able to lift up to 10 lbs
•Repetitive pipeting

• Managing electronic calendar, scheduling & global meeting management including coordination of telepresence, videoconference, teleconference meetings and meeting materials
• Creating, editing presentations, spreadsheets and word documents, proofreading and compilation of special reports.
• Handling correspondence and shared electronic filing system
• Making extensive international travel arrangements.
• Preparing expense reports.
• Initiating and managing purchase orders and contract processes including PO, invoices and payment tracking.
• Arranging various recruiting activities such as on-site interviews.
• Coordinating meeting and conference arrangements, planning off-site, town hall meetings, and organizing catering
• Leading the PTD administrative team meetings to ensure alignment, awareness of new business processes, and create a sense of community. 
• Delegating various departmental administrative responsibilities and supporting the growth and development of the PTD administrative team.

Product Manager or Sr. Product Manager - Launch Strategy - Bio-Oncology 

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Each Senior Product Manager has the opportunity to work on molecules at various stages of development.

Key activities for this role include:

• Representation of Managed Care Marketing in product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. 

Provide GMP compliance expertise to internal and external customers.

Perform tasks and work to achieve company goals and organizational objectives.

·         Follow company policies and procedures.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines.

·         Manage competing priorities and allocate, adjust, and optimize assigned department resources.

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Manage department and cross-functional initiatives.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Serve as a technical subject matter expert (SME) in support of department functions.

·         Develop and train personnel and internal customers on relevant business processes.

·         Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.

·         Collaborate and author department policies and procedures.

·         Make decisions that impact the goals and objectives of the department.

·         Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·         Perform any other tasks as requested by Management to support Quality oversight activities.

·         Participates in audits.  Lead audits.  Can develop audit findings that address individual gaps and system gaps.  Can lead all “low risk” and most “high risk” area audits.  Can participate on all high risk audits.  Report requires little or no input from manager.  May be asked to participate in meetings post audit to discuss unresolved issues with Senior Management.

·         Identifies gaps in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations.  Leads teams to remediate or defend identified risks.  Works with customers to develop CAPs and CAs for identified audit findings.  Presents information on outcomes to Sr. Management.

·         Will be assigned compliance opinions.  Needs no guidance from manager on resources / references. Opinion has depth and breadth and requires little or no input from Manager / review team.

·         Identifies gaps in corporate practices, policies and procedures.  Leads efforts to remediate gaps.  Write and or participate in corporate document development.

·         Participates in response development to regulatory inspection observations.  Author responses if assigned. Acts as a SME for GMPC.

·         Participates in FDA Meetings.  Acts as a SME for GMPC.

·         Participate as a GMPC representative in team meetings.  Is a SME on compliance issues. Independently raises compliance issues with the team.  Provides input on issues discussed informing manager of resolution. Communicates issues to manager as necessary.

·         Leads mock PAIs

·         Attends meetin...

This position may be filled at a Contract Manager  or Sr. Contract Manager level.
 
The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with partners in field Account Management across MCCO Channel and Payer Field teams as well as GNE Government Affairs, reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• As needed, supports field Account Management partners in negotiating contract terms and conditions
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities
•  Business travel, by air or car, is required for regular internal and external business meetings
  

Product Manager / Sr. Product Manager – Managed Markets Launch Strategy, Growth Disorders

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch.

PM/SPMs in the Managed Markets Launch Strategy group are generally responsible for multiple molecules at various stages of development. This opening would be primarily focused on leading launch preparations for a compound treating a growth disorder, which could represent a significant advance for patients.

Key activities for this role include:

• Execution of Managed Care Marketing deliverables for product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc.
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include brand marketing, health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Contract Services Manager 

Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, may perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules 
• Responds to questions/inquiries; may include policies, pricing, payment calculations, contract performance, complianc...

Department:   Site Services
Cost Center Name:  Site Engineering
Based on candidate experience the position can be either leveled as a Principal or a Senior Program Manager (E5/E4)

Responsibilities:

This position manages and directs a portfolio of construction projects <$10M at the Genentech South San Francisco campus (including Dixon and Redwood City). The program manager is the direct interface between an internal Genentech customer group and the Site Engineering outsourced project delivery service provider on each project within their portfolio and is accountable for the successful delivery of the entire portfolio while ensuring a high level of customer service.  The program manager role is strategic, customer facing, and leverages performance management principles to accomplish the work.  Key responsibilities include:

Customer Interface and Project Planning
The program manager is the direct interface between Site Engineering and the key representative(s) of a major Genentech functional group such as Research, PTD, Workplace Planning, Facility Operations & Maintenance, SSF Production, Energy Program and EH&S.  The program manager will be highly engaged with the customer to assist in developing new project scopes, providing input on initial costs and schedules for that customer’s portfolio of work (cLRP level estimates), and assist the customer in driving project starts.  To support this work in the Planning/Project Initiation stage, the program manager will engage resources as appropriate for constructability reviews, alternative analysis, scheduling, estimating, etc., to assist the customer in creating initial scope documents, which capture the initial scope, schedule, estimate, conceptual layoutsplans and key planning assumptions.  Service Level Agreements are developed and adhered to for the specific customer group.

Portfolio Management
The program manager will be responsible for the portfolio of projects executed for their customer group, overseeing all of the projects from planning stage to closeout and completion. The program manager will work with the project delivery service provider to assign projects to project managers from the service provider, and will be engaged with the status of each of these projects, providing input and strategic direction between them based on customer needs.  The cash flow and budget & resource management of the functional area’s portfolio shall be the responsibility of this role, as will assisting the customer in prioritizing their portfolio to meet available project resources. A key deliverable for the program manager will be the creation of a portfolio financial report, detailing the budget and cash flow status of the portfolio on a monthly basis.

Project Delivery
The basic function of this position is to ensure delivery of innovative and cost effective design and construction strategies for various construction projects at the Genentech South San Francisco campus (including Dixon and Redwood City) for each internal customer group.  The project portfolio consists of multiple small projects with total project costs up to $10M each. The typical program manager’s portfolio consists of 40-60 active projects at any given time, and totals approximately $12M-$20M of annual spend. The projects are delivered through a third party supplier who operates within the limits established by agreed upon scopes, budgets, and schedules of approved projects and makes decisions to control the work within these limitations.  The third party supplier executes projects through established project delivery processes, which includes key stakeholder engagement in defining project requirements and scope, business case justification, economic evaluations required to secure financial approval, and ensuring that projects meet intended functionality while controlling costs. The program manager works with the customer to define the project at a high level in the “Project Initiation” stage, and passes it to the project delivery service provider to initiate the project into the “Concept Design” stage, where the service provider takes over full responsibility of the project through completion.  The program manager oversees the work of the service provider with performance based / performance managed oversight.

Finally, a key role for the program manager is leadinggiving presentations to upper management to obtain funding for each project, usually in stages (i.e design phase funding, then construction phase funding). The service provider will prepare initialdraft presentation materials for the program manager, but final presentation creation and delivery to management is a key role of the position. The approving audience will consist of the Site Services Vice President and Directors. For proj...

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature