AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on creating technologies that expand the utility and improve the safety of cell-based immunotherapy for cancer, is seeking a Director of Clinical Operations to manage details and relationships related to the Company’s ongoing and future clinical trials.
Working hand-in-hand with our Chief Medical Officer, you will join a small team at a dynamic startup. You will collaborate within and outside the organization to help us meet our clinical development goals. With your superb communication skills, creativity, attention to detail, and flexibility, you will leave an indelible mark on Affy.
Location: Natick, MA
DIRECTOR OF CLINICAL OPERATIONS
Clinical Trial Operations
- Provide technical guidance to ensure that clinical trials are properly defined, planned, and executed
- Track cost, quality, and timeliness of assigned programs
- Ensure prioritization of activities and study objectives align with development strategy and corporate goals
- Contribute to the selection, management of external vendors, including timeliness, budget, and qualification
- Collaborate with Site PIs for feedback on study protocols, development plans and enrollment
- Provide input on clinical trial strategy into the integrated development plan to expedite development, maximize the probability of success, and mitigate risks
- Contribute to business development activities, including due diligence and analysis of programs
- Other duties as assigned
- Bachelor of Science with a major in life sciences (biology, chemistry, biochemistry, immunology, etc.) required. Advanced degree (M.S., Ph.D.) preferred.
- Minimum 5 years of clinical trial execution experience in the US. Small biotech experience, especially with biologics, preferred but not required. Experience establishing ex-US clinical trials a plus.
- Thorough working knowledge across a broad range of drug development areas. Experience with Investigational New Drug (IND) applications and New Drug Application (NDA) submissions a plus.
- Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- In-depth working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Must demonstrate a firm commitment to achieving Affy’s objectives while maintaining the highest ethical, regulatory, and scientific standards.
- Highly organized, collaborative, and motivated in a fast-paced startup environment.
This is a salaried, benefit-eligible position.