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Senior Medical Director, Rheumatology
Job description
Senior Medical Director, Rheumatology in Clinical Development
Remote, US
Are you a passionate leader in clinical development with a strong drive to make a difference in the lives of patients? A global biotechnology company is looking for a Senior Medical Director, Rheumatology to join its Clinical Development team. This is a unique opportunity to lead groundbreaking programs and collaborate with cross-functional teams to develop innovative therapies.
What You’ll Do
- Lead the creation and execution of Clinical Development Plans (CDPs) from IND to submission, ensuring alignment with company strategy and goals.
- Oversee clinical trials across Phases 1-3, including biomarkers, proof-of-concept, and full development studies.
- Collaborate with cross-functional teams (Regulatory, Safety, Translational Development, Market Access, etc.) to drive project success.
- Author and review key regulatory documents, including INDs, Investigator Brochures, CTAs, and BLA submissions.
- Provide medical and scientific expertise for study teams and external stakeholders, including regulatory authorities.
- Analyze clinical data, review adverse events, and resolve queries to maintain the highest standards of quality and compliance.
- Represent the Clinical function in internal governance and external meetings with regulatory authorities (FDA, EMA).
- Identify project risks and implement mitigation strategies to meet timelines and ensure deliverables.
- Lead and mentor Clinical Research Scientists, fostering a culture of excellence and innovation.
- Stay ahead of medical and industry trends to inform strategic decision-making.
What We’re Looking For
- MD or MD-PhD with 5+ years of clinical development experience in the pharmaceutical or biotech industry.
- Proven expertise in leading registrational studies and navigating regulatory processes (e.g., IND, NDA/BLA).
- Strong clinical knowledge, preferably with experience in rheumatology or immunotherapy.
- Demonstrated leadership in matrixed environments, with a track record of achieving results through collaboration.
- Excellent communication, analytical, and organizational skills.
This is your chance to play a pivotal role in the development of life-changing therapies. If you’re ready to lead with passion and purpose, we want to hear from you!
Note: This role is remote and based in the US. Company details will be disclosed during the interview process.