Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics (ECET) within the Translational Medicine Unit. Located in Cambridge, MA and Morristown, NJ. You will drive translation from preclinical and early clinical development, contributing to human target validation and pharmacology understanding across therapeutic modalities, including small molecules, antibodies, peptides, and gene therapies. You will collaborate across disciplines to design early development plans, execute early clinical studies, and support decision-making for go/no-go milestones.

Responsibilities

• Participate in designing the early development plan and ECET plan for clinical development, integrating with the overall development strategy in collaboration with the responsible Therapeutic Area in R&D.
• Design safe, rapid, and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal-seeking studies, and streamlined Proof-of-Mechanism and Proof-of-Concept studies to support early Go/No Go decisions and PK studies.
• Supervise execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation (informed consent forms, clinical protocols, study reports; abstracts/manuscripts; components of investigator brochures/regulatory documents).
• Interact with managers across disciplines; serve as expert/internal consultant and liaise with project partners.
• Participate in dose selection for First-In-Human studies and drive Go/No Go decisions when needed.
• Ensure adequate follow-up of studies and adherence to project timelines.
• Present data at appropriate meetings (inside or outside the organization).

Qualifications

• Required: Solid experience in design and execution of early development clinical trials (phase 1a/b and 2a) and exploratory studies in industry, academia, hospital, site/CRO.
• Preferred: Knowledge in translational research; experience with late-phase clinical trials.

Education

• Mandatory: Advanced degree (MD or MD/PhD) with 1–5 years of research experience; postgraduate residency training; broad biomedical knowledge; ability to acquire/apply new technical skills.
• Preferred: MD/PhD strongly preferred.

Skills

• Very good verbal and written communication for cross-functional interactions and regulatory engagement.
• Ability to challenge decisions with a risk-management mindset.
• Ability to work within a matrix organization across CPS, TMU, R&D and beyond (e.g., Medical).
• International/intercultural working skills; openness to digital/AI-driven solutions.

Additional Requirements

• Languages: English (fluent).
• Travel expectations not specified; operational role within TMU/CPS/ECET.