Medical Director, Clinical Development

POSITION OVERVIEW:

The Medical Director, Clinical Development is a key clinical leader responsible for providing medical and scientific leadership across the design, execution, and interpretation of clinical development programs supporting Disc’s pipeline. Reporting to the Executive/Senior Medical Director of the program, this individual will be able to work in a fast-paced environment and collaborate with cross-functional teams and external stakeholders to advance innovative therapies from early clinical development through later-stage development and regulatory evaluation.

The Medical Director will be responsible for assigned clinical studies and serve as a key medical interface with Clinical Science, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, Translational Medicine, Medical Affairs, and other functions. Responsibilities include medical oversight of clinical trials, clinical development strategy and study design, interpretation of emerging data, and support of regulatory and scientific communications.

The initial focus will be a clinical-stage program targeting iron metabolism. The successful candidate will bring expertise in hematology and/or anemia, clinical research experience, and a strong understanding of drug development.

RESPONSIBILITIES:

Clinical Development & Medical Leadership

• Provide medical and strategic leadership for assigned programs and studies.
• Partner with the Program Medical Director and cross-functional teams to develop and execute clinical development plans, including objectives, designs, endpoints, milestones, and strategies.
• Provide medical/scientific input into protocols, investigator brochures, informed consents, statistical analysis plans, clinical study reports, and regulatory documents.
• Serve as a subject matter expert on disease biology, clinical practice, treatment paradigms, unmet needs, and the competitive landscape.
• Interpret internal and external data to inform development strategy and program decisions.
• Develop relationships with investigators, KOLs, and external experts and support scientific conferences and competitive intelligence activities.

Clinical Trial Design, Execution & Medical Monitoring

• Serve as Study Physician and/or Medical Monitor for assigned trials, providing medical oversight of patient safety, data quality, and clinical conduct.
• Contribute to trial design, including patient populations, eligibility criteria, endpoints, assessments, and monitoring strategies.
• Review patient eligibility, protocol deviations, adverse events, laboratory findings, and emerging safety and efficacy data.
• Partner with Clinical Operations, Data Management, investigators, sites, and vendors to support high-quality study execution.
• Support investigator meetings, advisory boards, DSMC meetings, and other clinical/scientific activities.

Clinical & Regulatory Documentation

• Support clinical content for INDs, CTAs, protocols, investigator brochures, annual reports, clinical study reports, and other regulatory submissions.
• Contribute to regulatory strategy and health authority interactions, including preparation for meetings and responses to questions.
• Ensure clinical activities comply with applicable regulations, ICH-GCP, ethical standards, and company SOPs.
• Maintain high standards of scientific rigor, patient safety, data integrity, and compliance.

Cross-Functional Leadership & Collaboration

• Represent Clinical Development on cross-functional program teams and governance forums.
• Collaborate with Clinical Science, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Translational Medicine, CMC, and Medical Affairs.
• Translate clinical/scientific insights into actionable strategies and align multidisciplinary teams.
• Support program timelines, risks, resources, milestones, business development, due diligence, and external collaborations as needed.

Scientific Communication & External Engagement

• Develop and contribute to abstracts, posters, presentations, manuscripts, and other scientific communications.
• Present clinical data and development strategies to internal and external audiences.
• Establish relationships with investigators, KOLs, and experts in hematology, anemia, iron metabolism, and related fields.
• Support advisory boards and other external scientific engagement activities.

REQUIREMENTS:

Education & Clinical Training

• MD, MD/PhD, DO, or equivalent medical degree.
• Board certification/eligibility in Hematology/Oncology, Hematology, Oncology, Internal Medicine, or related specialty preferred.
• Fellowship training in a relevant field strongly preferred.
• 3–5+ years of relevant clinical research and/or clinical development experience in biopharma, pharma, CRO, academia, or clinical research.
• Demonstrated experience designing, executing, overseeing, or interpreting clinical trials, with increasing study-level responsibility.
• Medical monitoring, study physician, investigator, or clinical development experience strongly preferred.
• Experience with clinical development strategy, regulatory submissions, and/or health authority interactions preferred.
• Strong scientific track record, including publications and/or presentations, is a plus.
• Candidates with strong academic clinical research and trial expertise may be considered in lieu of direct industry experience.

Knowledge & Skills

• Strong knowledge of clinical research methodology, trial design, biostatistics, and safety/efficacy data interpretation.
• Strong scientific and medical judgment with the ability to translate data into actionable strategies.
• Excellent communication, presentation, collaboration, and influencing skills.
• Ability to thrive in a fast-paced, entrepreneurial environment with evolving priorities.
• Demonstrated ability to balance strategic thinking with hands-on execution and attention to detail.
• Commitment to patient safety, scientific integrity, and ethical clinical research.

Travel

• Approximately 20-25% travel may be required for investigator meetings, advisory boards, regulatory interactions, scientific conferences, and other business needs.