Department: Clinical Development
Job Title: Medical Director, Clinical Development
Job Location: South San Francisco, CA
We are seeking an experienced individual to be a Medical Director reporting to the Vice-President 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 expertise in Phase 2 and 3 drug development clinical studies. The position will require providing expert scientific, medical, and drug safety contributions (eg medical monitor, safety monitor) into the design, conduct, and assessment of clinical studies. The candidate must have experience or potential to serve as a team leader for clinical and cross-functional teams.
Major Duties & Responsibilities:
- Execute and supervise clinical studies, analyze results and write study reports.
- Contribute to the clinical sections of regulatory documents and meetings.
- Interact with regulatory agencies throughout the development process.
- 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.
- Consult with key opinion leaders, as needed, to ensure drug development activities are in line with current medical knowledge and standards.
- 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
- A doctoral degree (MD, DO, PhD, PharmD, etc) is required.
- Three or more years of pharmaceutical industry drug development experience is required.
- 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 required. 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.