Sr. Manager - Director, Clinical Development - South San Francisco, CA | Biospace
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Sr. Manager - Director, Clinical Development

Theravance Biopharma US, Inc.

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Location:
South San Francisco, CA
Posted Date:
6/9/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Development, Director, Manager,

Job Description


Senior Manager, Associate Director, or Medical Director (depending on the qualification of the applicant), Clinical Development

We are seeking experienced individuals to be a Senior Manager, Associate Director, or Medical Director reporting to a Medical Director of Clinical Development at Theravance.  This position will collaborate with colleagues in the Clinical Development and other company departments to assure successful, high-quality drug development.  Candidates for this position should have a doctoral degree, and prior experience in industry is preferable.  The position will require providing scientific, medical, and/or drug safety contributions (eg medical monitor, safety monitor) into the design, conduct, and assessment of clinical studies.

•   Execute and supervise clinical studies, analyze results and write study reports.
•   Contribute to the clinical sections of regulatory documents and meetings.
•   Manage the drug development process from protocol creation thorough individual study report and integrated regulatory document creation.
•   Collaborate with contributing groups such as Biostatistics, Drug Safety, Regulatory Affairs, Quality Assurance, Project Planning, and Clinical & Medical Affairs, etc.
•   Collaborate with external contract service vendors, Investigators, and clinicians.
•   Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for clinical studies

Requirements


•   A doctoral degree (MD, DO, PhD, PharmD, etc) is required.
•   Three or more years of pharmaceutical industry drug development experience is preferable.
•   Experience and expertise in creating and implementing drug development strategies resulting in efficient and successful product approvals.
•   Expertise in the regulations and guidance (CFR, ICH, GCP) governing drug development.  Expertise in clinical study monitoring, eg, assessing adverse events, safety lab test results, ECGs, etc.
•   Expertise in the clinical drug development process is preferable.  Effective leader of clinical research staff.  Exceptional interpersonal skills.  Ability to create highly functional, collaborative, and successful clinical teams.
•   Expertise in assuring high-quality clinical trial conduct management, data management, and data analysis.
•   A detailed understanding of human pathophysiology and pharmacology is required.  In addition, expertise in medicine and drug safety assessment is required.
•   A record of working effectively on clinical and cross-functional development teams.
•   Expertise in problem solving for addressing clinical and conduct issues that may occur during study management.
•   Comfortable working in a fast-paced, highly dynamic, and matrix pharmaceutical company.
•   Excellent oral and written communication skills.  Expert with Microsoft Office programs.