Job Description
Job DescriptionWe are seeking an experienced and motivated Medical Director to serve as the clinical lead for our myotonic dystrophy type 1 (DM1) program. Reporting directly to the Head of Research & Development, this individual will support a cross-functional, matrix team and provide strategic clinical leadership from early development through to late-stage execution. They will be responsible for the design, implementation, and oversight of the global clinical development plan with the goal of obtaining regulatory approvals in multiple regions.
The ideal candidate brings strong clinical and scientific expertise, preferably in neuromuscular or neurodegenerative diseases and a proven track record in clinical development, including hands-on experience guiding cross-regional teams and managing complex programs in a dynamic, fast-paced environment.
Responsibilities
- Serve as the clinical lead for the myotonic dystrophy type 1 program, providing direction and oversight across all phases of clinical development.
- Lead a multi-disciplinary, multi-regional matrix team in the execution of the clinical development plan.
- Design and maintain a scientifically sound and strategically aligned global development program, integrating medical, regulatory, and commercial perspectives.
- Serve as a clinical subject matter expert to internal stakeholders and external collaborators, including investigators, key opinion leaders (KOLs), and regulatory authorities.
- Provide medical input into the design of clinical study protocols, review study documents, and oversee the conduct of trials as medical monitor.
- Interpret and monitor data from ongoing and completed studies, contributing to decision-making processes including “go/no-go” decisions and study design modifications.
- Author or contribute to key regulatory and clinical documentation including investigator brochures, clinical study reports, regulatory responses, and briefing documents.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and company SOPs.
- Collaborate with colleagues across functions (Regulatory, Commercial, Preclinical, Biometrics, and Operations) to align on program objectives and deliverables.
- Stay abreast of developments in the DM1 field and relevant therapeutic landscapes to inform strategy and execution.
Requirements
- MD, MD/PhD, required
- 5+ years of clinical research experience within pharma or biotech
- Therapeutic experience in neuromuscular or neurodegenerative disease strongly preferred; direct experience in myotonic dystrophy is a plus.
- Demonstrated ability to lead cross-functional clinical development teams and matrix environments across regions.
- Strategic thinking, strong decision-making ability, and high emotional intelligence.
- Familiarity with global regulatory requirements; IND/NDA/MAA submission experience preferred.
- Exceptional verbal and written communication and interpersonal skills.
- Comfortable presenting to internal leadership, external collaborators, and scientific audiences.
- Willingness to travel domestically and internationally as needed and engage virtually with stakeholders as required.
About PepGen
PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.
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