Senior Clinical Trials Manager (Biotech Oncology)

About the role

The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of 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.

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.
• 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 engage 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.

Requirements

BA/BS in biological sciences or related field and a minimum of 9 years of related experience; or, MA/MS in biological sciences or related field and a minimum of 7 years of related experience; or, PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience; or, Equivalent combination of education and experience.

Qualifications

• Experience/The Ideal For Successful Entry Into Job 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.
• Knowledge/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 on scientific and clinical issues terminology.
• Experience with management of multinational clinical trials.
• Experience in interactions with outside vendors, e.g., CROs and contract labs.
• Detailed knowledge of regulations and guidelines.
• Excellent organizational and planning skills.
• Strong interpersonal and communication skills (both written and oral).
• Ability to work effectively in a team/matrix environment.
• Applies strong analytical and business communication skills.

Skills

• Approaches problems and solutions with an enterprise mindset, considering broad impact to portfolio, regional and global functions.
• Curious in planning; agile in execution.
• Operational excellence and drives others towards excellence.
• Resilient in the context of a rapidly changing environment.
• Organized with a systematic approach to prioritization.
• Exhibits Exelixis Leadership Commitments.

Benefits

Base pay range: $172,000 - $245,000 annually.

Comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

Discretionary annual bonus program or sales-based incentive plan for field sales staff.

Opportunity to purchase company stock.

Long-term incentives.

Accrued vacation days: 15 in the first year.

Paid holidays: 17 including a company-wide winter shutdown in December.

Sick days: up to 10 throughout the calendar year.