Sr Director, Clinical Development (Rare Disease)

CSG Talent

Middlesex County, MA, USA

Published: 6/14/2022

Healthcare

Full Time

Job Description

Senior Director, Clinical Development

We are seeking an experienced and innovative Senior Director, Clinical Development to provide strategic and operational leadership for early-stage rare disease drug development programs. This role will play a pivotal part in shaping preclinical-to-clinical strategy, preparing for regulatory engagement, and ensuring the successful transition into first-in-human studies. Ideal for candidates who thrive in agile, entrepreneurial biotech environments, this position offers the opportunity to impact multiple high-potential programs from the ground up.

Key Responsibilities

Serve as the medical lead for rare disease programs from pre-IND through early clinical phases.
Partner with preclinical and translational teams to define target product profiles and clinical development pathways.
Lead the design of early-stage clinical development strategies, including biomarker selection, patient population definition, and study endpoints.
Oversee or contribute to authoring key clinical and regulatory documents, including INDs, clinical protocols, investigator brochures, and regulatory briefing packages.
Collaborate with Regulatory Affairs to prepare for FDA, EMA, and other agency interactions.
Engage and build relationships with key opinion leaders, patient advocacy organizations, and external collaborators.
Provide medical expertise in evaluating new opportunities for portfolio expansion.
Maintain up-to-date knowledge of scientific, clinical, and regulatory developments in rare disease research.

Qualifications

Education

MD or MD/PhD required; board certification in a relevant specialty preferred.

Experience

5+ years of clinical development experience, with a focus on rare disease or orphan indications.
Direct experience in early-stage (pre-IND through Phase 1/2) drug development.
Demonstrated ability to operate effectively in small, fast-paced biotech or startup environments.
Familiarity with global regulatory requirements and experience preparing for agency meetings.

Skills

Deep understanding of clinical trial design and translational medicine principles.
Excellent written and verbal communication skills; comfortable presenting to scientific and non-scientific audiences.
Entrepreneurial mindset with the ability to adapt to shifting priorities.