Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics. Location: Cambridge, MA; Morristown, NJ.

Drive translation between preclinical development and early clinical development across therapeutic areas, including small molecules, antibodies, peptides, and gene therapy modalities. Integrate outputs from multiple disciplines into translational medicine and human target validation plans to evaluate pharmacology and identify signals of efficacy or safety for new indications.

Responsibilities

• Participate in designing the early development plan and ECET strategy for various steps of clinical development, aligned with the overall development plan.
• Design safe, rapid, and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal-seeking approaches, and Proof-of-Mechanism/Proof-of-Concept studies.
• Supervise study execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation (informed consent, protocols, study reports, abstracts/manuscripts, investigator brochures, regulatory documents).
• Interact with multidisciplinary managers; act as expert and internal consultant and liaise with project partners.
• Participate in dose selection for FIH studies and drive Go/No Go decisions.
• Ensure adequate study follow-up and adherence to timelines.
• Present data at internal or external meetings.
• Serve as Study Medical Manager for selected clinical studies, overseeing design/conduct of early development studies (e.g., Phase 2a) and coordinating documentation and team setup.
• Lead Dose Escalation Meetings and document decisions; review adverse event reports.
• Participate in data review/validation meetings and prepare key results memos and clinical study reports.

Qualifications

• Solid experience designing and executing early development clinical trials (Phase 1a/b and 2a) and exploratory studies in pharma, academia, clinical sites, or CROs.

Nice To Have Qualifications

• Knowledge in translational research.
• Experience in conducting late-phase clinical trials.

Education

• Advanced degree: M.D. or M.D./Ph.D with 1‚Äì5 years of research experience; postgraduate residency; broad biomedical knowledge; ability to acquire new technical skills.
• M.D./Ph.D. strongly preferred.

Soft And Technical Skills

• Excellent verbal and written communication across functions and with regulatory agencies.
• Ability to challenge decisions with a risk-management approach.
• Ability to work within a matrix organization (CPS, TMU, R&D, Medical).
• International/intercultural working skills; openness to digital/AI-driven solutions.

Languages

English fluent.