Biological sciences Jobs in Berkeley, CA

Senior Clinical Trials Manager, Clinical Operations

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).

Essential Duties And 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.

Supervisory Responsibilities:

None

Education/Experience/Knowledge & Skills:

Education/Experience:

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.

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

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

Job Complexity:

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

Desired Behaviors:

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

Exhibits Exelixis Leadership Commitments:

We drive for results, so patients can survive and thrive.

We are resilient in the face of adversity, and tireless in advancing our science.

We celebrate our long history of prolific drug discovery and rigorous drug development.

We unite to launch innovative medicines for difficult-to-treat cancers.

We exist to give people hope one drug, one patient at a time.

We are Exelixis.

Lives The Exelixis Core Values Daily:

Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),

Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results)

Excel for Patients (Innovate to design solutions and remove barriers to show how much we care)

Working Conditions:

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