Title: Clinical Program Lead
Salary: $140-$150K
Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Program Lead for a hybrid role in the SF Bay Area. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Program Lead with EU trial experience to drive their pipeline forward.
***** Candidate must be based in SF Bay Area to be considered.*****
The Clinical Program Lead will be responsible for:
- Leading the design, monitoring, data interpretation and reporting activities related to the conduct of clinical studies, in accordance with applicable regulations, ICH/GCP regulations and Standard Operating Procedures (SOPs) within assigned program(s)
- Implementing processes and initiatives to support the clinical program and study delivery driving overall portfolio delivery
- Supporting the Director, Global Clinical Affairs (Clinical Operations, this is NOT a medical device position)
- Oversight and execution of:
- Scientific components of the program (e.g. scientific literature review)
- Protocol development, implementation of Quality by Design principles
- Study Monitoring, oversight of data quality, patient safety
- Data management/cleaning activities
- Clinical sites (e.g. support clinical study leads / project associates in mgmt and oversight)
- Direct reports within the Clin Ops team
An ideal candidate for this role MUST have…
- Experience establishing and/or managing a clinical trial program in EU
- 5+ years of sponsor experience - REQUIRED
- 2+ years of experience managing studies or trials EU - REQUIRED
- 2+ of experience managing direct reports
- A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline
- A working knowledge of ICH GCP guidelines
Benefits:
- Competitive salary with benefits
- High degree of commercial exposure early in your career
- Being a part of team whose work directly aims to improve the quality of people's lives
- Great work-life balance
If you are interested in this Clinical Program Lead role, please apply.
