Exelixis
Clinical Operations Associate Director (Biotechnology / Oncology)
Exelixis, Alameda, California, United States, 94501
Overview
The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of 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 role is the Study Delivery Lead (SDL) for oncology products from early to late phase and may involve in-house, outsourced and alliance delivery models. The SDL leads the Study Delivery Team (SDT) and collaborates with Global Clinical Operations and Product Matrix Teams. Responsibilities
Accountable for the global study delivery strategy and overall study deliverables (e.g., country selection, diversity, patient engagement strategy, recruitment plan). Guide assessment, selection, engagement, management, and oversight of vendors. Ensure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs for all products and services delivered for designated studies. Make decisions balancing risk/benefit with impact on the study; mitigate risk where appropriate. Collaborate with matrix partners and Clinical Operations leadership to develop and manage the study-level budget within project allocation. Prepare materials for internal governance and financial review cycles. Partner to build relationships and collaborate with aligned staff in other functions. Encourage matrix and line teams to seek alternate perspectives and develop solutions. Lead and conduct investigator meetings and other study-related meetings; 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 inspection readiness. Lead or contribute to process improvement initiatives and ways of working. Provide expert clinical operational input into protocol development. Partner with Data Management and Clinical Sciences to develop data cleaning strategy. As the SDL, lead the SDT and actively collaborate with SDT members. Work with functions to develop patient-centric documents and address patient burden. Engage Clinical Operations staff in process development, problem solving, and training initiatives as needed. Provide proactive oversight of CRO and vendor performance. Support study-level status updates with emphasis on delivery to corporate and project objectives. Supervisory Responsibilities
None, but as a Study Delivery Lead, this role will mentor junior Clinical Operations staff. Education/Experience/Knowledge & Skills
Education/Experience
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 capability to drive delivery within time, cost, and quality. Proven experience leading high-performing global study teams in Oncology trials. Identify and resolve issues to ensure timely delivery to quality, timelines, and budget. Excellent leadership, influencing, and negotiation skills. Ability to work in a matrix environment to deliver projects and manage change. Knowledge of study management or data management and global regulatory guidelines and ICH/GCP. Experience with investigators, external experts, regulatory agencies, and oversight of CROs and third-party vendors, including troubleshooting with CRO partners and conducting After Action Reviews. Ability to build relationships at all levels in a dynamic, matrixed environment. Strong project and budget management skills. Competent in authoring patient-facing materials, study procedures, manuals, and informed consent forms. Applied broad expertise to contribute to company objectives and policies; capable of strategic thinking and transformation. Ability to interpret and modify company-wide policies; may influence organizational policy in major areas. Extensive knowledge of related disciplines and strong analytical and business communication skills. Job Complexity
In-depth knowledge of the functional area, business strategies, and company goals. Exercises independent judgment in methods and evaluation criteria. Creates formal networks coordinating across groups. Analyzes cross-organizational processes and escalates risks to upper management. Establishes relationships across levels in a dynamic environment with conflict management and negotiation skills. Strong communication and stakeholder management across the organization. Uses tools to track, oversee, and communicate project status and issues to stakeholders. Desired Behaviors
Enterprise mindset; considers broad portfolio impact. Ability to analyze and solve new business problems. Curious in planning; agile in execution. Operationally excellent; drives others to excellence. Resilient in a rapidly changing environment. Organized with systematic prioritization. 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 history of drug discovery and 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. Working Conditions
Travel may be required up to 20% in support of clinical study activities. Disclaimer: The preceding job description describes the general nature and level of work performed by employees within this classification and is not intended to be an exhaustive inventory of all duties, responsibilities, and qualifications. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.
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The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of 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 role is the Study Delivery Lead (SDL) for oncology products from early to late phase and may involve in-house, outsourced and alliance delivery models. The SDL leads the Study Delivery Team (SDT) and collaborates with Global Clinical Operations and Product Matrix Teams. Responsibilities
Accountable for the global study delivery strategy and overall study deliverables (e.g., country selection, diversity, patient engagement strategy, recruitment plan). Guide assessment, selection, engagement, management, and oversight of vendors. Ensure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs for all products and services delivered for designated studies. Make decisions balancing risk/benefit with impact on the study; mitigate risk where appropriate. Collaborate with matrix partners and Clinical Operations leadership to develop and manage the study-level budget within project allocation. Prepare materials for internal governance and financial review cycles. Partner to build relationships and collaborate with aligned staff in other functions. Encourage matrix and line teams to seek alternate perspectives and develop solutions. Lead and conduct investigator meetings and other study-related meetings; 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 inspection readiness. Lead or contribute to process improvement initiatives and ways of working. Provide expert clinical operational input into protocol development. Partner with Data Management and Clinical Sciences to develop data cleaning strategy. As the SDL, lead the SDT and actively collaborate with SDT members. Work with functions to develop patient-centric documents and address patient burden. Engage Clinical Operations staff in process development, problem solving, and training initiatives as needed. Provide proactive oversight of CRO and vendor performance. Support study-level status updates with emphasis on delivery to corporate and project objectives. Supervisory Responsibilities
None, but as a Study Delivery Lead, this role will mentor junior Clinical Operations staff. Education/Experience/Knowledge & Skills
Education/Experience
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 capability to drive delivery within time, cost, and quality. Proven experience leading high-performing global study teams in Oncology trials. Identify and resolve issues to ensure timely delivery to quality, timelines, and budget. Excellent leadership, influencing, and negotiation skills. Ability to work in a matrix environment to deliver projects and manage change. Knowledge of study management or data management and global regulatory guidelines and ICH/GCP. Experience with investigators, external experts, regulatory agencies, and oversight of CROs and third-party vendors, including troubleshooting with CRO partners and conducting After Action Reviews. Ability to build relationships at all levels in a dynamic, matrixed environment. Strong project and budget management skills. Competent in authoring patient-facing materials, study procedures, manuals, and informed consent forms. Applied broad expertise to contribute to company objectives and policies; capable of strategic thinking and transformation. Ability to interpret and modify company-wide policies; may influence organizational policy in major areas. Extensive knowledge of related disciplines and strong analytical and business communication skills. Job Complexity
In-depth knowledge of the functional area, business strategies, and company goals. Exercises independent judgment in methods and evaluation criteria. Creates formal networks coordinating across groups. Analyzes cross-organizational processes and escalates risks to upper management. Establishes relationships across levels in a dynamic environment with conflict management and negotiation skills. Strong communication and stakeholder management across the organization. Uses tools to track, oversee, and communicate project status and issues to stakeholders. Desired Behaviors
Enterprise mindset; considers broad portfolio impact. Ability to analyze and solve new business problems. Curious in planning; agile in execution. Operationally excellent; drives others to excellence. Resilient in a rapidly changing environment. Organized with systematic prioritization. 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 history of drug discovery and 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. Working Conditions
Travel may be required up to 20% in support of clinical study activities. Disclaimer: The preceding job description describes the general nature and level of work performed by employees within this classification and is not intended to be an exhaustive inventory of all duties, responsibilities, and qualifications. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.
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