Clinical Development Lead (MD) – Cardio-Metabolic & Renal

Job Title: Clinical Development Lead (MD) – Cardio-Metabolic & Renal

Job Number: 36055

Location: Cambridge, MA

Job Description

We are seeking a highly skilled and motivated Clinical Development Lead (MD) to drive early-stage clinical development from discovery candidate (DC) through Investigational New Drug (IND) applications and into Phase I trials. This individual will play a critical role in shaping clinical strategy and executing first-in-human studies. The ideal candidate will have deep expertise in cardio-metabolic and renal indications and a proven track record in early-stage clinical development.

Responsibilities

● Lead the clinical development strategy for programs in cardio-metabolic and renal diseases, ensuring alignment with corporate objectives.
● Oversee the transition from discovery candidate (DC) selection through IND submission and into early clinical trials (Phase I).
● Design and execute clinical studies, including first-in-human (FIH) trials, ensuring scientific rigor and regulatory compliance.
● Collaborate with cross-functional teams and consulting partners, including preclinical, regulatory, translational, and commercial teams, to develop and execute clinical development plans.
● Work closely with regulatory authorities (FDA, EMA, etc.) to guide IND submissions and regulatory interactions.
● Lead medical and scientific aspects of clinical trial design, including protocol development, investigator selection, and data analysis.
● Serve as the medical expert for internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory agencies.
● Monitor safety and efficacy data, ensuring timely decision-making for program progression.
● Contribute to the company’s overall R&D strategy, providing clinical insights for pipeline expansion.

Required Skills

● MD required, preferably with specialization in cardiology, nephrology, endocrinology, or related fields.
● 5+ years of experience in clinical development within the biotech or pharmaceutical industry.
● Demonstrated experience leading programs from discovery through IND and into early clinical trials (Phase I).
● Expertise in cardio-metabolic and renal indications is essential.
● Strong knowledge of regulatory requirements and clinical trial design for early-phase development.
● Ability to work in a fast-paced, startup environment with a hands-on, strategic mindset.
● Excellent leadership, communication, and collaboration skills.
● Must be able to work on-site Monday – Friday