Senior Clinical Trials Manager (Biotechnology, Oncology)

Exelixis Inc.•Alameda, CA

33d

About The Position

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).

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.
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
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
Demonstrated matrix leadership skills
Detailed knowledge of regulations and guidelines
Excellent organizational and planning skills
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Strong interpersonal skills and communication skills (both written and oral)
Ability to work effectively in a team/matrix environment
Applies strong analytical and business communication skills
Capable of anticipating, identifying, prioritizing and resolving task-related challenges
Ability to write and present clearly especially on scientific and clinical issues
Ability to work effectively in a team/matrix environment
Excellent interpersonal, organizational, supervisory and project planning skills.
Demonstrated professional collaboration skills
Approaches problems and solutions with an enterprise mindset, considering broad impact to portfolio, regional and global functions
Ability to study, analyze and understand new situations and business problems and identify appropriate solutions
Curious in planning; agile in execution
Operationally excellent and drives others towards excellence
Resilient in the context of a rapidly changing environment
Organized with a systematic approach to prioritization

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.
ctively 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.

Benefits

Exelixis offers 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.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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