Job Details

Overview

Clinical Operations Associate Director, (Biotechnology Oncology)

The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of solid tumor oncology clinical trials with leadership in study teams and across matrix teams. This position 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 Clinical Operations Associate Director 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. This role is highly visible within Global Clinical Operations and in the Product Matrix Teams. The SDL is the leader of the Study Delivery Team (SDT).

Responsibilities

• Accountable for the oncology global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables.
• Guide assessment, selection, engagement, management, and oversight of appropriate vendors.
• Assure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies.
• Make decisions that balance risk/benefit with clear understanding of impact on the study and project; take action to mitigate risk where appropriate.
• Collaborate 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.
• 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.

Supervisory Responsibilities

• None, but as a Study Delivery Lead, this role will mentor junior Clinical Operations staff.

Education/Experience / Knowledge & Skills

• BS/BA and a minimum of 11 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD/PharmD in biological sciences or related field and a minimum of 5 years of related experience; or,
• Equivalent combination of education and experience.

Experience / The Ideal For Successful Entry Into Job

• Experience in Biotech/Pharmaceutical industry preferred.
• Management experience including outsourcing to Contract Research Organizations (CROs).

Knowledge / Skills

• Extensive clinical development experience with at least 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical / biotech industry or CRO environment.
• Proven operational experience of leading high performing global study teams in Oncology clinical trials.
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
• Excellent leadership and negotiation skills.
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
• In-depth knowledge of either study management or data management and essential global regulatory guidelines and ICH/GCP.
• Proven experience working with investigators, external experts and regulatory agencies and oversight of CROs and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.
• Ability to establish and build internal and external relationships at all levels in a dynamic, matrixed environment.
• Excellent project management and budget management skills.
• Competent at authoring patient-facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.
• Broad expertise to contribute to company objectives and principles in creative and effective ways.
• Interprets and recommends modifications to company-wide policies and/or divisional programs.
• Has extensive knowledge of related disciplines and strong analytical and business communication skills.

Job Complexity

• In-depth knowledge of the functional area and business strategies.
• Judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks coordinating among groups.
• Analyzes cross-organizational processes and escalates risks to upper management.
• Establishes relationships in a dynamic, matrixed environment with conflict management and negotiation skills.
• Strong communication skills and ability to influence stakeholders at all levels.
• Uses tools to track, oversee and communicate project status and issues to stakeholders.

Desired Behaviors

• Enterprise mindset, considering broad impact to portfolio, regional and global functions.
• Ability to study, analyze and understand new situations and problems and identify solutions.
• Curious in planning; agile in execution.
• Operationally excellent and capable of leading others toward excellence.
• Resilient in a rapidly changing environment.
• Organized with a systematic approach to prioritization.

Disclaimers and Benefits

• Exelixis offers comprehensive employee benefits including a 401k plan, medical/dental/vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program; stock purchase and long-term incentives; vacation, holidays, and sick days as described in the full policy.
• We are an Equal Opportunity Employer and do not discriminate based on race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability or any other protected class.

Working Conditions

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

Note: This job description reflects essential responsibilities and qualifications and is not intended to be all-inclusive. It is subject to change at the company's discretion.