Clinical Operations Associate Director, (Biotechnology Oncology)

Role Summary

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.
• Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes 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.
• Responsible for the preparation of 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.

Qualifications

• 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

• 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 skills, influencing 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 knowledge of essential global regulatory guidelines and ICH/GCP.
• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations 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 highly dynamic and matrixed environment.
• Excellent project management skills and budget management skills.
• Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.

Additional Requirements

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