Senior Clinical Trials Manager (Biotechnology/Oncology)

Role Summary

The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams. This position within Clinical Operations is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds. The Senior Clinical Trials Manager, Clinical Operations, is the Study Delivery Lead (SDL). The SDL is the study accountable person, and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. The SDL is the Clinical Operations leader of the Study Delivery Team (SDT).

Responsibilities

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables.
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
• Ensure compliance with ICH/GCP guidelines, all applicable laws, and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.
• Prepare materials for internal governance and / or financial review cycles.
• Actively partner to build relationships and collaborate with aligned staff in other functions.
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
• Lead / contribute to ways of working and process improvement initiatives.
• Provide expert clinical operational input into protocol development.
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study.
• As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members.
• Work with the appropriate functions to develop patient centric documents and address patient burden.
• Contribute to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed.
• Provide proactive and consistent oversight of CRO and vendor performance.
• Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

Qualifications

• BA/BS in biological sciences or related field with a minimum of 9 years of related experience; or
• MA/MS in biological sciences or related field with a minimum of 7 years of related experience; or
• PhD/PharmD in biological sciences or related field with a minimum of 2 years of related experience; or
• Equivalent combination of education and experience.
• Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management.

Skills

• Experience in either starting a study up, working on the maintenance phase, or close-out of study
• Protocol development experience
• Proven ability to provide clinical expertise to a clinical development program
• Proficiency in clinical studies involving complex design
• Experience in independent preparation of clinical sections of IND, BLA, or NDA
• Demonstrated ability to write and present clearly using scientific and clinical issues terminology
• Experience with management of multinational clinical trials
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Demonstrated matrix leadership skills
• Detailed knowledge of regulations and guidelines
• Excellent organizational and planning skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment
• Aplies strong analytical and business communication skills

Education

• As listed in Qualifications

Additional Requirements

• Travel may be required up to 20% in support of clinical study activities