Position Title: Medical Director, Clinical Development – Rheumatology
Location: United Kingdom (Remote)
Reports To: Vice President, Clinical Development
Job Type: Full-Time
About the Company
Our client is a leading biopharmaceutical company focused on advancing groundbreaking therapies for patients with unmet medical needs. Our mission is to improve lives by developing innovative treatments that address complex diseases, including those in the field of rheumatology. We foster a culture of collaboration, excellence, and patient-centred care.
Position Summary
We are seeking a highly skilled and experienced Medical Director for Clinical Development with a background in Rheumatology to join our dynamic team. This individual will play a pivotal role in designing, implementing, and overseeing clinical trials for novel therapies in the rheumatology space. The ideal candidate will bring deep expertise in rheumatologic diseases, clinical trial management, and a passion for advancing patient care through innovative research.
Key Responsibilities
Clinical Strategy and Development
* Develop and execute clinical development strategies for pipeline products in rheumatology.
* Provide medical and scientific leadership to cross-functional teams, including Research, Regulatory Affairs, Biostatistics, and Pharmacovigilance.
* Contribute to the preparation of clinical development plans (CDPs), including protocol design and endpoints aligned with regulatory and commercial objectives.
Clinical Trial Oversight
* Serve as the medical lead for assigned clinical trials, ensuring scientific rigor and compliance with regulatory requirements.
* Collaborate with investigators, study sites, and contract research organizations (CROs) to ensure quality and timeliness of clinical trial execution.
* Monitor trial safety, efficacy data, and overall progress, addressing any issues as they arise.
* Lead data review and interpretation, providing medical input for interim and final analyses.
Regulatory and Medical Affairs
* Contribute to the preparation of regulatory submissions, including INDs, NDAs, and BLAs, ensuring alignment with global regulatory standards.
* Participate in interactions with regulatory agencies, advisory boards, and key opinion leaders (KOLs).
* Support medical affairs activities, including the development of publication plans, medical education programs, and advisory boards.
Cross-Functional Collaboration and Leadership
* Act as a key medical and scientific advisor to internal and external stakeholders.
* Mentor and guide junior clinical development staff as needed.
* Stay abreast of advances in rheumatology and related therapeutic areas to inform clinical development strategies.
Qualifications
Education and Experience
* MD or equivalent with board certification in Rheumatology required.
* Minimum of 5-8 years of experience in clinical research and/or drug development, preferably in the biopharmaceutical or biotechnology industry.
* Demonstrated expertise in rheumatologic diseases, with experience designing and leading clinical trials in this area.
Skills and Knowledge
* Strong understanding of clinical trial design, methodology, and regulatory requirements.
* Exceptional analytical and problem-solving skills, with the ability to synthesize complex data.
* Proven ability to communicate effectively with internal teams, external partners, and regulatory authorities.
* Strong leadership and collaboration skills, with the ability to influence cross-functional teams.
Preferred Qualifications
* Experience in global clinical trials and knowledge of international regulatory requirements.
* Familiarity with biomarkers, precision medicine, or innovative trial designs in rheumatology.
* Track record of publications or contributions to the scientific community in rheumatology or related fields.
What We Offer
* Competitive compensation and benefits package.
* Opportunities for professional growth and development.
* A collaborative and innovative work environment committed to improving patient outcomes.