Exelixis, Inc.
Clinical Trials Manager (Biotechnology Oncology)
Exelixis, Inc., Alameda, California, United States, 94501
·
Manages clinical trials, including those conducted through Contract Research Organizations (CROs)·
May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams·
May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)·
BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or,·
MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or,·
PhD/PharmD in biological sciences or related field and zero or more years of related experience; or,·
Equivalent combination of education and experience.·
Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research·
Experience in either starting a study up, maintenance phase, or study close-out·
Experience with development of prospective site-selection criteria·
Protocol development experience·
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures·
Ability to deal with time demands, incomplete information or unexpected events·
Experience in interactions with outside vendors, e.g., CROs and contract labs·
Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations·
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology·
Strong organizational and planning skills·
Strong interpersonal skills and communication skills (both written and oral)·
Ability to work effectively in a team/matrix environment·
Ability to understand technical, scientific, and medical information·
Ability to anticipate and resolve problems·
Ability to write and present clearly, especially on scientific and clinical issues·
Ability to work effectively in a team/matrix environment·
Demonstrated professional collaboration skills·
Ability to study, analyze and understand new situations and business problems and identify appropriate solutions·
Works independently to meet objectives and completes tasks within established timelines.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. #J-18808-Ljbffr
Manages clinical trials, including those conducted through Contract Research Organizations (CROs)·
May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams·
May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)·
BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or,·
MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or,·
PhD/PharmD in biological sciences or related field and zero or more years of related experience; or,·
Equivalent combination of education and experience.·
Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research·
Experience in either starting a study up, maintenance phase, or study close-out·
Experience with development of prospective site-selection criteria·
Protocol development experience·
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures·
Ability to deal with time demands, incomplete information or unexpected events·
Experience in interactions with outside vendors, e.g., CROs and contract labs·
Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations·
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology·
Strong organizational and planning skills·
Strong interpersonal skills and communication skills (both written and oral)·
Ability to work effectively in a team/matrix environment·
Ability to understand technical, scientific, and medical information·
Ability to anticipate and resolve problems·
Ability to write and present clearly, especially on scientific and clinical issues·
Ability to work effectively in a team/matrix environment·
Demonstrated professional collaboration skills·
Ability to study, analyze and understand new situations and business problems and identify appropriate solutions·
Works independently to meet objectives and completes tasks within established timelines.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. #J-18808-Ljbffr