Clinical Operations Associate Director

• Accountable for the 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 SMT and actively partner to build relationships and collaborate with SMT
• 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.

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

• 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,
• Equivalent combination of education and experience.
• May require certification in assigned area.

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

• 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.

• Has an in-depth knowledge of the functional area, business strategies and the company’s goals.
• Exercises separate judgment in methods, techniques and evaluation of criteria for obtaining results.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.
• Serves as an external spokesperson for the organization.

• 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.

• 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)

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

Exelixis