Salary: $210,000 - $225,000
Director Clinical Operations
San Diego, CA (Hybrid)
Job Description
EPM is partnered with an Autoimmune focused Biotech in San Diego, California, who is looking to bring on a skilled Director of Clinical Operations to help oversee their clinical stage assets. They are a smaller company (~100 FTE Employees) who has already been able to get a drug approved, have a robust pipeline (8 clinical stage assets), and a proven drug platform. With multiple strong data readouts over the last few months, they are excited about the potential of getting another drug on the market soon, and have multiple early stage assets that have a chance to treat large populations of patients. Their financial runway has been extended until 2027 through fundraising, and have seen consistent upticks in revenue from their marketed asset. This combination of potential for growth and financial stability is a rare opportunity, and not one to miss out on.
Roles & Responsibilities
- Develop and implement strategic plans for clinical trials in alignment with the company's overall objectives and regulatory requirements.
- Ensure the effective management of CROs (Contract Research Organizations), vendors, and other external partners involved in clinical trial activities.
- Foster effective communication and collaboration among internal teams and external stakeholders, including investigators, site personnel, and regulatory authorities.
- Represent the company in interactions with regulatory agencies, ensuring clear and timely communication of clinical trial progress and results.
- Establish and maintain high-quality standards for clinical trial conduct in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal standard operating procedures.
Key Qualifications
- Bachelors degree in a Life Sciences related field
- Prior experience working on the sponsor side (preferrably most recently for the last 5 years)
- At least 7 years of trial management experience
- Preferance for candidates who have experience working on autoimmune indications
- Experience overseeing juniors and managing direct reports
- Knowledge of clinical operations as it relates to GCP, ICH, and SOP guidelines
Benefits
- Medical, dental, vision insurance
- 401(k)
- PTO and Holidays
- Target bonus/competitive salary
