Senior Clinical Trials Manager; Biotechnology, Oncology

Position: Senior Clinical Trials Manager (Biotechnology, Oncology)
· 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/Pharm

D 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 solutions

Every 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.
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