We are an innovative, science-driven biotechnology company focused on developing novel therapeutics for pulmonary diseases, including COPD and other serious inflammatory conditions. Our team combines deep discovery and development expertise with a nimble, collaborative culture to advance cutting-edge programs from early research through late-stage clinical development and commercialization.
Position Summary
Reporting to the SVP Clinical Development, the Study Physician | Medical Director will play a critical role in the design, execution, and medical oversight of clinical trials across our pulmonary portfolio, with an emphasis on early- to mid-stage development and potential expansion into additional later-stage programs.
This individual will serve as the medical lead for assigned clinical studies, providing strategic and hands-on input into protocol design, study conduct, safety monitoring, and data interpretation. The ideal candidate is a clinically trained physician with prior industry experience in clinical development, preferably within respiratory, inflammation, or immunology, and brings a balance of scientific rigor and operational execution excellence.
The Study Physician | Medical Director will work cross-functionally with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Pharmacovigilance to ensure high-quality, efficient execution of clinical trials in alignment with global regulatory expectations.
Key Responsibilities
- Serve as the medical lead for assigned clinical trials, providing oversight from study concept through execution and reporting.
- Contribute to the design and development of clinical protocols, including endpoints, inclusion/exclusion criteria, and safety monitoring plans.
- Provide ongoing medical monitoring of clinical trials, including review of safety data, adverse events, and protocol deviations.
- Partner closely with Clinical Development, and Clinical Operations to support study execution, site interactions, and CRO oversight.
- Participate in the development of clinical development plans and broader program strategy.
- Collaborate with Regulatory Affairs to support regulatory submissions, briefing documents, and health authority interactions (e.g., FDA, EMA).
- Contribute to the analysis and interpretation of clinical data, including preparation of clinical study reports, abstracts, and publications.
- Work with Translational Medicine and Clinical Pharmacology to incorporate biomarkers, PK|PD, and disease insights into study design and analysis.
- Support pharmacovigilance activities, including safety signal detection and risk management strategies.
- Engage with external stakeholders, including investigators, key opinion leaders (KOLs), and advisory boards.
Qualifications
- MD (or MD/PhD) required.
- 3-5+ years of experience in clinical development within biotechnology or pharmaceutical industry.
- Prior experience as a Study Physician, Medical Monitor, or Medical Director supporting clinical trials.
- Experience in respiratory, pulmonary, immunology, or inflammatory diseases strongly preferred.
- Working knowledge of clinical trial design, GCP, and global regulatory requirements (FDA, EMA).
- Experience supporting Phase 1–3 clinical trials; experience in global studies is a plus.
- Strong ability to interpret clinical and safety data and translate insights into development decisions.
- Excellent cross-functional collaboration and communication skills.
- Ability to thrive in a fast-paced, entrepreneurial biotech environment with a hands-on approach.
Why Join Us
- Opportunity to lead clinical strategy for late-stage, potentially registrational respiratory programs.
- High-impact executive role with direct influence on pipeline success and patient outcomes.
- Collaborative, science-driven culture with strong executive alignment.
- Competitive compensation, equity participation, and comprehensive benefits package.