Medical Director Clinical Development
Medical Director Clinical Development
Greater Boston Area - Hybrid
Compensation: $250,000-330,000 + 20% bonus + Lucrative RSU package
Company Summary:
We're partnering with a mid‑sized biotech leading the way in endocrine and orphan lung disease therapeutics. With two FDA‑approved products generating over $300 million in revenue last year, the company is scaling rapidly and building on real commercial success. Their innovative inhaled delivery platform supports small molecules and biologics, creating a versatile foundation for future programs. You'll have the chance to work on a pipeline backed by proven, clinically validated science, while contributing to the next wave of breakthrough therapies.
If this excites you, we encourage you to apply and learn more.
Primary Responsibilities:
- Lead clinical trials with full GCP compliance.
- Manage recruitment, data quality, medical monitoring, and safety oversight.
- Oversee CRO activities and collaborate with Biostats, Data Management, and Clinical Operations.
- Ensure regulatory alignment, data integrity, and quality assurance.
- Support strategy and design for Phase 1-4 trials.
- Review literature, define eligibility criteria/endpoints, and evaluate data using modeling tools.
- Serve as clinical study lead.
- Prepare regulatory documents (IND, NDA) and contribute to clinical protocols, reports, and submissions.
- Present to internal committees and support first-in-human meetings.
- Analyze and communicate study data internally and externally.
- Partner with Medical Directors, Medical Writing, Drug Safety, Translational Medicine, Regulatory, CROs, investigators, advisory boards, and KOLs.
- Represent Clinical Development on project teams; may serve as project lead.
- Present updates to senior management and contribute to business development/due diligence.
- Provide medical, clinical, and safety support in endocrinology.
- Perform other duties as needed.
Ideal Qualifications:
- 3+ years clinical development experience in industry.
- MD or foreign equivalent.
- Pulmonary/ Respiratory experience.