Senior Clinical Trials Manager (Biotech Oncology)
Exelixis, Inc.
· Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.· Work with the appropriate functions to develop patient centric documents and address patient burden.· BA/BS in biological sciences or related field and a minimum of 9 years of related experience; or,· MA/MS in biological sciences or related field and a minimum of 7 years of related experience; or,· PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience; or,· Equivalent combination of education and experience.· Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management· Experience in either starting a study up, working on the maintenance phase, or close-out of study· Protocol development experience· Proven ability to provide clinical expertise to a clinical development program.· Proficiency in clinical studies involving complex design.· Experience in independent preparation of clinical sections of IND, BLA, or NDA· Demonstrated ability to write and present clearly using on scientific and clinical issues terminology· Experience with management of multinational clinical trials· Experience in interactions with outside vendors, e.g., CROs and contract labs· Demonstrated matrix leadership skills· Detailed knowledge of regulations and guidelines· Excellent organizational and planning skills· Demonstrated ability to write and present clearly using on scientific and clinical issues terminology· Strong interpersonal skills and communication skills (both written and oral)· Ability to work effectively in a team/matrix environment· Applies strong analytical and business communication skills· Ability to write and present clearly especially on scientific and clinical issues· Ability to work effectively in a team/matrix environment· Excellent interpersonal, organizational, supervisory and project planning skills.· Demonstrated professional collaboration skills · 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 Exelixis, Inc.
$172k - $245k
...SUMMARY/JOB PURPOSE The Senior Clinical Trials Manager, Clinical Operations, combines end‑to‑end design, execution, and reporting of clinical trials... ...Delivery Lead (SDL) and may oversee studies spanning oncology products from early through late phase, utilizing in‑house...SeniorContract workLocal areaFlexible hours$172k - $245k
Summary The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of clinical trials with leadership... ...Manager serves as the Study Delivery Lead (SDL) for oncology products from early through late phase, coordinating in‑...SeniorContract workFlexible hours$136k - $192.5k
...SUMMARY/JOB PURPOSE The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating...SuggestedContract workLocal areaFlexible hours- Exelixis, Inc. seeks a Clinical Trials Manager in Alameda, California, to oversee activities related to clinical trials, collaborating with CROs and vendors to ensure compliance and quality of execution. Candidates must possess a strong background in life sciences with...Suggested
$172k - $245k
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- ...The position We are seeking an exceptionally strong, hands‑on senior scientist to help drive scientific progress in the development... ...reproduction Ownership: Operate with autonomy in a fast‑moving biotech startup and build a program end‑to‑end Growth: Develop and lead...SeniorFlexible hours
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