Dynetherapeutics
Medical Director, Clinical Development
Waltham, MA. Posted 3 months ago
The role
The Medical Director, Clinical Development serves as a key member of the DM1 clinical development team. This person will execute critical studies, provide medical monitoring, and ensure participant safety for clinical programs.
What you will do
- Contribute to the planning, design, development, and implementation of clinical trials
- Serve as medical monitor for assigned studies
- Review clinical and safety data, eligibility questions, and adverse events
- Partner with Pharmacovigilance to support safety surveillance and signal detection
- Collaborate with Clinical Operations to ensure study activities meet regulations and timelines
- Manage relationships with CROs, vendors, and external collaborative partners
- Review and interpret clinical, safety, biomarker, and pharmacodynamic data
- Contribute to medical review for protocols, investigator brochures, and regulatory responses
- Identify and manage relationships with external collaborators, investigators, and advisors
- Provide leadership and mentorship to clinical development team members
Required qualifications
- Doctor of Medicine degree
- 5+ years of relevant experience
- 3+ years of clinical development, medical monitoring, pharmacovigilance, clinical research, or related roles within the pharmaceutical or biotechnology industry
- Experience serving as a medical monitor or providing medical oversight for interventional clinical trials
- Strong understanding of clinical trial design, protocol execution, medical data review, safety monitoring, and clinical development processes
- Working knowledge of FDA, EMA, ICH, GCP, and other applicable regulatory requirements for clinical trials
- Regulatory experience with Pre-lNDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
- Experience reviewing and contributing to clinical and regulatory documents
- Ability to interpret clinical, safety, biomarker, pharmacodynamic, and efficacy data
- Strong clinical judgment
- Ability to work effectively in a fast-paced, matrixed biotechnology environment
- Excellent written, verbal, and presentation skills
Nice to have
- Board certification or advanced training in neurology, neuroscience, neuromuscular disease, pediatrics, internal medicine, or a related specialty
- Experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas
- Experience working with CROs, investigators, study sites, and external experts
About the company
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for other diseases.