Senior Medical Director, Clinical Development – Rheumatology

Meet Life Sciences is representing a small, innovative biotech company who are seeking a Senior Medical Director to provide clinical and medical leadership for the development of novel therapies for autoimmune and rheumatologic diseases. This physician will shape clinical development strategy and lead study execution, with responsibility for medical monitoring, patient safety, and interpretation of clinical data. Working closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Drug Safety, this individual will advance clinical programs and build relationships with investigators and external experts. The role requires a hands-on physician who combines rheumatology expertise with industry clinical development experience.
Responsibilities
Develop and execute clinical development plans for investigational therapies targeting autoimmune and rheumatologic diseases.
Serve as medical lead for one or more clinical studies, providing oversight from protocol development and study startup through data analysis and reporting.
Lead medical monitoring activities, including review of eligibility, safety events, laboratory findings, efficacy assessments, and protocol deviations.
Serve as the primary physician contact for investigators and study teams, addressing clinical questions and supporting appropriate patient management within the protocol.
Partner with Drug Safety to evaluate adverse events, assess emerging safety signals, and implement appropriate risk mitigation measures.
Author and review protocols, investigator brochures, informed consent forms, clinical study reports, and clinical sections of regulatory submissions.
Contribute to indication selection, endpoint strategy, patient selection, biomarker plans, and interpretation of clinical and translational data.
Support regulatory interactions, including preparation of briefing materials and responses to health authority questions.
Establish relationships with investigators, key opinion leaders, and patient advocacy organizations.
Present clinical data and program updates to internal leadership, advisory boards, investigators, and scientific audiences.
Provide medical oversight of CROs and other external partners.
Mentor clinical development colleagues and contribute to the growth of the medical team.
Qualifications
MD or equivalent medical degree required.
Fellowship training in rheumatology required; board certification or eligibility preferred.
Typically 5+ years of pharmaceutical or biotechnology clinical development experience, with leveling based on the depth of program leadership and relevant expertise.
Demonstrated experience designing, conducting, and medically monitoring interventional clinical trials.
Clinical expertise in one or more rheumatologic indications, such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, inflammatory myopathies, Sjögren’s disease, or vasculitis.
Strong understanding of clinical trial methodology, safety assessment, GCP, and applicable regulatory requirements.
Ability to critically evaluate clinical data and translate findings into development decisions.
Excellent communication skills and the ability to lead across functions in a collaborative environment.
Required Skills
Demonstrated experience designing, conducting, and medically monitoring interventional clinical trials.
Clinical expertise in one or more rheumatologic indications, such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, inflammatory myopathies, Sjögren’s disease, or vasculitis.
Strong understanding of clinical trial methodology, safety assessment, GCP, and applicable regulatory requirements.
Ability to critically evaluate clinical data and translate findings into development decisions.
Excellent communication skills and the ability to lead across functions in a collaborative environment.
Preferred Skills
Early clinical development, including first-in-human studies, dose escalation, and proof-of-concept trials.
Development of biologics, cell therapies, or other novel immunomodulatory treatments.
Experience with regulatory submissions and health authority interactions.
Experience working in a small or midsize biotechnology company.
Leadership of global studies and external scientific advisory meetings.

Work arrangement
Yes