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.

The Opportunity:

As an integral member of our dynamic team, you will:

Strategic Outsourcing & Portfolio Planning

• 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.

Vendor Identification, Evaluation & Selection

• 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.

CRO Relationship & Performance 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.

Financial & Operational Management

• 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.

Governance, Partnership & Organizational Leadership

• 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.

Process Improvement

• 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.

Who You Are:

• 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.

Please note: This position requires the candidate to be available for occasional travel both domestic and international.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $148,300 - $275,300.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  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.