Medical Director

POSITION OVERVIEW:

The Medical Director, Clinical Development is a key clinical leader responsible for the design, execution, and interpretation of clinical trials supporting the development of innovative therapies within Disc’s pipeline. Reporting to the Executive Medical Director, this individual provides strategic and scientific leadership to cross-functional teams, ensuring that clinical programs are conducted in accordance with regulatory requirements, ethical standards, and corporate objectives. This position will support a clinical-stage program focused on iron metabolism and anemia treatment using a novel, first-in-class negative regulator of hepcidin.

RESPONSIBILITIES:

• Clinical Strategy & Leadership
• Contribute to the overall clinical development strategy for assigned programs.
• Partner with the Executive Medical Director to define clinical development plans, trial designs, and program milestones.
• Provide medical and scientific input into target product profiles, study protocols, investigator brochures, and regulatory documents.
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Help to determine appropriate advisory boards experts
• Clinical Trial Oversight
• Serve as medical monitor for clinical trials, ensuring subject safety and data integrity.
• Provide clinical guidance to operational teams, investigators, and external partners.
• Review and interpret clinical data, prepare clinical study reports, and support publication activities.
• Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports
• Organize and present at relevant clinical advisory boards, DMC and medical/scientific meetings
• Cross-Functional Collaboration
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure seamless execution of clinical programs.
• Represent Clinical Development in internal governance meetings and cross-functional program teams.
• Support business development and alliance management activities as needed.
• Regulatory & Compliance
• Contribute to regulatory submissions (INDs, NDAs, BLAs, etc.) and interactions with global health authorities.
• Ensure compliance with GCP, ICH guidelines, and company SOPs.
• Scientific Communication & Leadership
• Prepare abstracts and manuscripts for publication/presentation
• Present clinical data to internal stakeholders, investigators, and at scientific conferences.
• Provide mentorship to junior medical or scientific staff.

 REQUIREMENTS:

• MD with research experience or MD/PhD, as well as a fellowship in Hematology/ Oncology or related areas with minimum of 10-12 years of related work experience
• Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
• Experience with developing clinical regulatory strategy
• Strong academic record with high quality peer-reviewed publications that demonstrate research productivity
• Track record of effective cross-collaboration within an organization, among teams, and external groups/organizations
• Expertise in data analysis and presentation
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Ability to clearly and effectively communicate to internal and external stakeholders orally and in writing
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Experience in regulatory submissions and interactions with FDA/EMA preferred.
• This role may require up to 20% travel for investigator meetings, regulatory interactions, or conferences.