Medical Director, Clinical Development

The role

The Medical Director, Clinical Development provides medical leadership for clinical trials and clinical development strategy. This person will oversee study design, execution, patient safety, and data interpretation for immunology therapies.

What you will do

• Lead and provide medical oversight for assigned clinical trials.
• Contribute to clinical development strategy and program plans.
• Provide medical leadership on trial design.
• Monitor real time data collection throughout study conduct.
• Support pharmacovigilance activities and monitor patient safety.
• Serve as a medical resource for investigative sites, external advisors, and clinical investigators.
• Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs.
• Review, author, and contribute to key clinical and regulatory documents.
• Support regulatory interactions and submissions.
• Serve as the clinical development lead for an asset if required.

Required qualifications

• Advanced clinical degree (MD or DO) or MD/PhD
• Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience
• Direct experience of phase 1-3 clinical studies
• Authoring clinical trial protocols, clinical development plans and regulatory submission documents
• Deep clinical and scientific expertise in immunology and inflammation
• Ability to identify, characterize, and mitigate clinical, operational, and regulatory risks
• Ability to lead and influence cross-functional teams in a matrixed, fast-paced biotech or pharmaceutical environment
• Ability to build alignment across diverse internal and external stakeholders
• Ability to drive program-level decisions with clarity and accountability
• Exceptional scientific communication skills
• Scientific writing proficiency

Nice to have

• Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty
• Additional advanced degree (PhD, MPH, or MBA)
• Direct experience treating, or managing lupus (SLE and/or CLE)and/or systemic sclerosis patients/clinical programs
• Deep scientific expertise in autoimmune disease — rheumatology, specifically lupus (SLE and/or CLE) or systemic sclerosis

Benefits

• Competitive health and wellness coverage
• Paid time off
• Public holidays
• Additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.