Exelixis, Inc.
Clinical Operations Associate Director (Biotechnology / Oncology)
Exelixis, Inc., Alameda, California, United States, 94501
·
Collaborate with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.·
Provide expert clinical operational input into protocol development.·
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·
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,·
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 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.·
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.·
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.·
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, showing conflict management and negotiation skills·
Highly developed communication skills appropriate to the target audience, promoting effective decision-making·
Effective influencing and stakeholder management skills at all levels of the organization·
Ability to study, analyze and understand new situations and business problems and identify appropriate solutionsEvery Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too. #J-18808-Ljbffr
Collaborate with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.·
Provide expert clinical operational input into protocol development.·
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·
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,·
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 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.·
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.·
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.·
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, showing conflict management and negotiation skills·
Highly developed communication skills appropriate to the target audience, promoting effective decision-making·
Effective influencing and stakeholder management skills at all levels of the organization·
Ability to study, analyze and understand new situations and business problems and identify appropriate solutionsEvery Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too. #J-18808-Ljbffr