Senior Strategic Outsourcing Manager
About The Position
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 45 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work. The Nonclinical Outsourcing Team provides nonclinical outsourcing support for the Development Sciences organization by identifying and selecting Contract Research Organizations (CROs) and ensuring study placement to enable prompt delivery of research and early development projects. The Senior Strategic Outsourcing Manager drives the nonclinical outsourcing strategy, serves as the business interface between Translational Safety (TS), tPKPD, and nonclinical Contract Research Organization (CRO) vendors to ensure placement of in-vivo and in-vitro toxicological and pharmacokinetic studies for drug candidates from research through late drug development phases. The candidate will work in partnership internally with functional leadership teams, the TS CRO management team (CMT), Toxicologists, Pathologists, Pharmacokinetic Scientists, Study Monitors, and Legal Contracts personnel.
Requirements
- BA, BS, or MS in biological sciences or related scientific field, or MBA with relevant work experience in the biopharmaceutical or CRO industry with a minimum of 12-year experience in comparable roles, e.g., outsourcing, procurement, or business development.
- Solid understanding of drug development, study design, procedures, data management systems, documentation practices, and regulatory requirements,
- Strong interpersonal skills with the ability to develop close working relationships with internal and external stakeholders.
- Detail-oriented with strong analytical ability and problem-solving skills.
- Excellent oral and written communication skills with the ability to influence and negotiate effective solutions.
Responsibilities
- Develop and execute the Translational Safety in-vivo, in-vitro, and Pathology outsourcing strategies.
- Possess an advanced understanding of portfolio needs and the dynamic global CRO landscape, including emerging innovative technologies and capabilities.
- Advise senior management on outsourcing strategies and anticipated portfolio needs.
- Proactively identify and address business needs, outsourcing risks, and opportunities to optimize the externalized portfolio.
- Monitor and evaluate changes in the CRO landscape to ensure business continuity and alignment with anticipated portfolio needs.
- Independently research and identify credible vendors and perform due diligence to assess technical and operational qualifications.
- Investigate CRO capabilities and lead scientific, technical, and business-related risk assessments to provide recommendations on CRO selection.
- Generate Requests for Information (RFIs) and Requests for Proposals/Quotes (RFPs/RFQs), manage the corresponding processes, negotiate costs and terms, summarize proposals, and present recommendations to senior management.
- Collaborate effectively with Procurement and Contracting teams to follow DevSci’s formal end-to-end outsourcing framework for vendor qualification, selection, contracting, oversight, and issue management.
- Develop and manage relationships with CROs at the operational level, including regular communications, issue management, and organization of vendor visits and meetings.
- Lead non-clinical CRO business reviews and vendor visits to ensure business continuity and effective execution of the Translational Safety and tPKPD outsourcing strategy.
- Monitor and review CRO performance and adherence to agreed-upon service levels, proactively identifying and resolving issues that may impact business objectives.
- Independently present at department and vendor meetings.
- Provide operational metrics and statistics to support data-driven outsourcing decisions and inform accurate financial forecasting via generic drug development models.
- Ensure Purchase Orders are established with accurate accounting codes and metadata to enable effective cost tracking and financial management.
- Proactively manage operational issues and risks to ensure continuity of outsourcing activities.
- Serve as the strategic outsourcing business lead in cross-functional groups, including Department Expert Working Groups (EWGs), Advisory Groups (AGs), and CRO liaison groups.
- Serve as a consultant to management on matters pertaining to organizational policies, industry regulations, and business objectives.
- Participate in company and external industry teams to influence and advance outsourcing practices, including monitoring and communicating regulatory, vendor, and industry developments.
- Drive continuous improvement of outsourcing processes, tools, and practices to increase efficiency, effectiveness, and business value.
- Identify opportunities to improve the end-to-end outsourcing model and implement solutions in partnership with relevant stakeholders.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- This position also qualifies for the benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
