Medical Director, Clinical Development (DM1)

Location: Waltham, Massachusetts, United States; onsite

Base pay: $270,000–$310,000 USD annually

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to improve function for people living with genetically driven neuromuscular diseases.

What you will do

• Lead medical oversight and execution of assigned DM1 clinical studies as the medical monitor.
• Contribute to clinical development strategy, study design, protocols, endpoints, biomarkers, patient stratification, and development plans.
• Review clinical, safety, biomarker, pharmacodynamic, and efficacy data to support participant safety, risk mitigation, and benefit-risk assessment.
• Partner with Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biostatistics, Data Management, Translational Medicine, CROs, investigators, and vendors.
• Support regulatory submissions, health authority interactions, clinical and regulatory documents, publications, presentations, and scientific communications.
• Build relationships with investigators, study sites, external collaborators, advisors, and key opinion leaders; provide leadership and mentorship to clinical development colleagues.

Requirements

• Doctor of Medicine degree or another relevant degree; board certification or advanced training in neurology, neuroscience, neuromuscular disease, pediatrics, internal medicine, or a related specialty is preferred.
• 5+ years of relevant experience, including 3+ years in clinical development, medical monitoring, pharmacovigilance, clinical research, or related pharmaceutical or biotechnology roles.
• 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, GCP, ICH, FDA, EMA, and other applicable regulations.
• Experience with Pre-INDs, INDs, CTAs, EOP 2 meetings, and NDA/BLA/MAA processes in the US and outside the US.
• Ability to work independently in a fast-paced, matrixed biotechnology environment and travel as needed for investigator meetings, site engagement, advisory boards, congresses, and internal meetings.

Nice to have

• 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.

Culture & Benefits

• Work in a growing, clinical-stage biotechnology company.
• Collaborate across Research, R&D, Clinical Operations, Regulatory Affairs, Medical Affairs, Finance, Legal, and Commercial functions.
• Contribute to programs addressing Duchenne muscular dystrophy, myotonic dystrophy type 1, and other neuromuscular diseases.