Restoring Balance. Renewing Life.
Director, Clinical Development
Location
California
Posted
47 days ago
Salary
$181.7K - $317.9K / year
Job Description
Job Requirements
- Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
- Experience in hepatology, MASH or internal medicine preferred
- Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred
- Direct experience in executing Phase III clinical trials, including medical monitoring responsibilities
- Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations
- Proven experience authoring or overseeing regulatory documents
- Strong interpersonal and communication skills
- Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data
- Demonstrated problem-solving ability and ownership of issues
- Comfortable working independently and as part of cross-functional teams
- Highly organized with strong prioritization and time-management skills
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
- Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
- Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.
Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance
- 401(k) savings plan
- flexible spending accounts
- employee assistance program
- tuition reimbursement program
- voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
- time off pursuant to its sick time policy
- flexible vacation policy
- parental leave policy
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