Director, Clinical Scientist

The role

The Director, Clinical Scientist supports the strategy, design, execution, interpretation, and communication of clinical studies. This role partners with cross-functional teams to advance clinical programs for rare, genetically driven neuromuscular diseases.

What you will do

• Serve as a clinical science lead or contributor for assigned studies.
• Provide scientific input into study design, patient population, and data collection strategies.
• Interpret emerging clinical data for study conduct and regulatory interactions.
• Partner with cross-functional teams to support study execution and mitigate risks.
• Collaborate with investigators, key opinion leaders, and vendors.
• Support ongoing patient-level and aggregate clinical data review.
• Partner with Pharmacovigilance to support safety surveillance and signal evaluation.
• Lead or contribute to the development of protocols, informed consent forms, and investigator brochures.
• Contribute to regulatory submissions and interactions.
• Mentor and coach clinical scientists and study team members.

Required qualifications

• Advanced degree in life sciences, healthcare, pharmacy, medicine, nursing, or a clinically relevant discipline
• 8+ years of relevant experience in clinical development, clinical science, clinical research, or related roles within the pharmaceutical or biotechnology industry
• Experience supporting or leading interventional clinical trials across multiple phases of development
• Experience supporting global, late-stage clinical trials and submissions
• Demonstrated understanding of clinical development strategy, study design, protocol development, regulatory documentation, data review, clinical trial execution, and study reporting
• Strong knowledge and experience with GCP, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements for clinical trials
• Experience developing or contributing to clinical and regulatory documents
• Strong ability to interpret clinical, safety, biomarker, pharmacodynamic, efficacy, and endpoint data
• Experience with clinical data review tools and systems including EDC systems, data listings, patient profiles, dashboards, Excel, and PowerPoint
• Demonstrated ability to lead complex clinical science workstreams and manage competing priorities
• Strong cross-functional collaboration and influencing skills
• Excellent written, verbal, and presentation skills

Nice to have

• PhD, PharmD, MD, or equivalent advanced degree
• Experience in rare disease, neuromuscular disease, genetic medicines, oligonucleotide therapeutics, or other complex therapeutic areas
• Experience working with CROs, investigators, study sites, key opinion leaders, advisory boards, or 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.