Director/AD of Clinical Operations
About The Position
DeepCure is seeking an exceptional Director of Clinical Operations to lead our transition from a discovery-stage powerhouse into a clinical-stage therapeutics company. In this pivotal role, you will be the primary owner and architect of DeepCure’s clinical operations, specifically focused on advancing our Immunology pipeline through Phase 1 and Phase 2 clinical trials. You will serve as a strategic bridge between our internal discovery/development teams and external clinical consultants, ensuring that our Discovery programs are effectively translated into robust clinical protocols. This is a high-visibility position with the opportunity to build the clinical infrastructure necessary to translate DeepCure’s molecules into life-changing medicines for patients in the immunology and autoimmune space. DeepCure is an AI-driven drug discovery company, founded by researchers from the MIT Media Lab, and focused on transforming how medicines are discovered and developed. By combining advanced computational platforms with deep biological and chemical expertise, DeepCure aims to deliver differentiated therapeutic candidates faster and more efficiently. As a small, highly collaborative biotech, we value scientific rigor, creativity, and adaptability.
Requirements
- Ph.D. or M.Sc. in Biological Sciences, Pharmacology, Immunology, or a related discipline.
- 10+ years of relevant industry experience in drug discovery and clinical operations leadership.
- Deep expertise in Immunology and autoimmune disease biology, including a strong understanding of relevant biomarkers and model systems.
- Proven track record of managing CROs and vendors for early-stage (Phase 1/2) clinical trials.
- Demonstrated ability to lead and mentor scientific staff.
- Solid understanding of GCP, ICH guidelines, and FDA regulations as applied to early clinical development.
- Excellent communication and scientific documentation skills, with the ability to convey complex clinical concepts to non-experts.
Nice To Haves
- Successful experience advancing a program from target validation through Clinical Candidate Nomination and first-in-human (FIH) trials.
- Prior experience in a biotech environment that leverages internal AI or computational platforms to support discovery and development
Responsibilities
- Lead Clinical Operations: Serve as the primary lead for all clinical operations, driving the execution of immunology programs through early clinical development, contributing to the clinical strategy. The preferred candidates will also be able to manage the final IND-enabling stages.
- Manage CROs & Vendors: Identify, select, and manage high-performing Contract Research Organizations (CROs) and vendors, ensuring scientific rigor and alignment with program goals.
- Bridging Discovery and Clinic: Work closely with the discovery and development teams to ensure a seamless translational hand-off and clinical readiness for lead immunology candidates.
- Operational Infrastructure: Build and scale internal clinical operations capabilities, including the development of Standard Operating Procedures (SOPs) and quality standards.
- Document Leadership: Lead the development of clinical protocols, Investigator’s Brochures (IBs), and Clinical Study Reports (CSRs) for immunology-driven programs.
- Data-Centric Oversight: Leverage AI-driven insights and complex datasets to guide operational decisions, site selection, and recruitment strategies.
- Budget Accountability: Oversee clinical trial budgets and resource allocation, ensuring trials are conducted on time and within financial scope.
- Regulatory Partnership: Represent clinical operations on cross-functional teams to support IND/CTA filings and ensure global regulatory compliance.
Benefits
- Flexible work hours with a hybrid working model
- Unlimited paid leave and sick time
- 401(k) plan with employer matching
- Healthcare, vision, dental, and life insurance plans for you and your dependents
- Employer contributions to a health spending account (HSA) and flexible spending account (FSA)
- Employer coverage public transportation expenses or parking
- Work in a cool and vibrant space at the heart of Boston
- Snacks, drinks, and regular social events for local and remote team members
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
1-10 employees
