What are the responsibilities and job description for the Senior Medical Director, Rheumatology position at BioTalent?
Senior Medical Director, Rheumatology in Clinical DevelopmentRemote, USAre 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.#J-18808-Ljbffr
