Biotech Jobs in Berkeley, CA

Senior Director, Clinical Operations

The Senior Director, Clinical Operations (ClinOps) is responsible for the worldwide execution of all oncology Phase I - IV clinical trials across the Exelixis portfolio. ClinOps plays a key role in ensuring all Exelixis clinical trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Exelixis' oncology products. The Senior Director, Clinical Operations represents ClinOps at the Product Development Team (PDT) as the Clinical Operations Program Lead. The Clinical Operations Program Lead is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for a product(s) and associated studies, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives. This position provides line leadership to Study Delivery Leads and / or Indication Leads from Senior Clinical Trial Manager to Director level to ensure optimal delivery of program clinical studies through the successful execution of the goals and deliverables outlined in the program corporate and project goals.

As a Senior Director, oversees large clinical programs and represents Clinical Operations on internal and external strategy teams, including Product Development Teams (PDTs) which entails accountability for the operational strategy and successful execution of all Clinical Development Plans related to your assigned programs, including financial accountability. This position is accountable for resource management across assigned program, including ongoing assessment of resource needs and optimal deployment of resources. Works seamlessly with CRO and vendors, attending governance and oversight meetings, to ensure optimal delivery to plan. Serves as an expert resource by offering input / ideas to solve operational challenges for all clinical studies in the assigned program and providing expertise to PDT, clinical sub team, etc. In addition, this role is an active member of the Clinical Operations leadership team, leading Clinical Operations and/or cross-functional organizational initiatives and strategies that promote change management to accelerate adoption. Typically acts as the business process owner (BPO) and/or serves as a subject matter expert for complex Clinical Operations processes. Demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations.

Essential Duties/Responsibilities

• Accountable within the Clinical Operations team for the operational delivery plan to execute the scientific strategy for a product and associated studies (phase 1 4), working in partnership with functional subject matter experts.
• Accountable for delivery of a program of studies in Oncology diseases; and be a key point of contact for portfolio leaders (e.g., Product Team Lead and/or Project Physician Leaders, as appropriate).
• Contribute to the Clinical Development Plan (CDP) and the development of protocols that align to the CDP to ensure operational feasibility and consistency within the program.
• Lead resourcing discussions on behalf of Clinical Operations, making recommendations on strategy; endorses the vendor(s) for the program and studies in accordance with the Clinical Operations resourcing strategy & principles; and ultimately approve the Clinical Operations FTE plan to support the program.
• Oversight of quality delivery by leading the Clinical Operations team to ensure excellence in operational planning and implementation; and being the escalation point for the program in Clinical Operations; ensuring inspection readiness at all times and having regular interactions with Study Delivery Leads involved in the program such that they are aware of issues / risks / successes with study delivery as they occur.
• Interact regularly for full service outsourced studies to a CRO, with the CRO Project Directors / Relationship Directors to ensure issues and risks are brought to the partnership level and addressed to ensure program success.
• Responsible for various scenarios for optimal program/study delivery linked to value drivers and drives decisions for governance boards to optimize delivery with transparent implications to time, quality, risks, and budget.
• Participate in and represent Clinical Operations at Product Development Team (PDT); co-lead Clinical Sub-team; and other internal governance boards as needed.
• Drive innovative approaches to study delivery through external facing advances in technology and science.
• Create strong strategic partnerships with colleagues, including Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Medical Writing, and other PDT / Sub team functions, to ensure consistent approaches to study delivery, data collection and reporting across a defined indication.
• Contribute relevant knowledge of scientific and medical literature in the Oncology field to apply to operational goals.
• Manage Study Delivery Leads and / or Indication Leads and a mentor to other Clinical Operations team members, with a particular emphasis on coaching and development.
• Oversee the preparation of budgets for internal governance boards, to include working with Strategic Sourcing and Procurement; Project Management; and Finance colleagues to ensure clear and comprehensive product / study level budgets are created, to include well-negotiated CRO and vendor contracts.
• Represent Clinical Operations in the development and finalization of annual Product corporate and project goals; continuously track and communicate status of goals throughout the year.
• Ensure the delivery of a program executive summary, ensuring delivery to plan status, key risks, appropriate mitigations, study, and program level metrics are provided, as requested.
• Manage all available tools to track, oversee and communicate appropriately all aspects of project status and any issues to all key stakeholders.
• Performs other duties as assigned
• Complies with all policies and standards

Supervisory Responsibilities

• Directly supervises employees approximately 3-6 direct reports.
• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.

Education/Experience/Knowledge/Skills & Abilities

• Bachelor's degree in related discipline and a minimum of 15 years of related experience; or,
• Master's degree in related discipline and a minimum of 13 years of related experience; or,
• PhD degree in related discipline and a minimum of 12 years of related experience; or,
• Equivalent combination of education and experience.
• Typically requires a minimum of 18 years of related experience or the equivalent combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.
• Management experience including outsourcing to Contract Research Organizations (CROs).
• Demonstrates conceptual, analytical, and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability
• Ability to translate strategic concepts, scientific requirements, stakeholder feedback and requirements into cohesive actions for the Product team.
• Ability to define value-driven vision and roadmap for the Clinical Development Plan
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, showing conflict management and negotiation skills
• Uses all available tools to track, oversee and communicate appropriately all aspects of project status and any issues to all key stakeholders.
• Strong financial acumen and ability to critically develop, review and track budgets.
• Strong track record of delivering matrix accountabilities and resource modeling (capacity/FTE requirements) to develop appropriate forecasts and deliver portfolio needs
• Strong study / program level timeline build and oversight skills.
• Partnering skills with key role such as clinical science, biostatistics, and other experts at product level to articulate and champion key decisions and strategy
• Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives
• Excellent influencing and stakeholder management skills at all levels of the organization.
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making
• Ability to effectively prioritize activities and stakeholder needs while balancing the broader business needs with the needs of their specific program
• Competent in working with complexity and uncertainty within the external regulatory environment (e.g., FDA, EMEA)
• Innovative and change adept while identifying and embracing risks as opportunities
• To be an external advocate, representing Exelixis at congresses, industry bodies or other external opportunities
• Ability to represent the Clinical Operations function in change initiatives or SME roles, embracing and promoting Exelixis' values and culture
• Extensive experience within the pharmaceutical industry or CRO environment in clinical operations
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and study delivery plans.
• Experience working with investigators, external experts, Contract Research Organizations, and vendors
• Broad understanding of the biotech / pharmaceutical industry and the clinical development process
• In depth knowledge of study management