Senior Director, Medical Director
Company: Dyne Therapeutics
Location: Waltham
Posted on: July 8, 2025
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Job Description:
Company Overview: Dyne Therapeutics is focused on delivering
functional improvement for people living with genetically driven
neuromuscular diseases. We are developing therapeutics that target
muscle and the central nervous system (CNS) to address the root
cause of disease. The company is advancing clinical programs for
myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy
(DMD), and preclinical programs for facioscapulohumeral muscular
dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to
deliver functional improvement for individuals, families and
communities. Learn more https://www.dyne-tx.com/ , and follow us on
X , LinkedIn and Facebook . Role Summary: The Senior Director,
Medical Director serves as a key member of the DM1 clinical team
leadership and has primary responsibility for the execution of the
integrated development strategy, including both in-house
development and potential strategic partnerships to augment the
internally developed pipeline. The Senior Director, Medical
Director is responsible for the development of the medical aspects
of the program. This role is responsible for delivering quality and
timely medical input and interpretation on specific program data in
fulfilment of the program objectives, working in partnership with
regulatory affairs and pharmacovigilance in providing medical
support for pharmacovigilance activities, responses to regulatory
agency queries, and development. This role is based in Waltham, MA
with the possibility of being a hybrid role. Primary
Responsibilities Include: Partner with the DM1 Clinical Development
Lead to guide the Clinical Development team across the planning,
design, development, and implementation of clinical trials for a
drug candidate. Develop knowledge of disease mechanisms to select
biomarkers, pharmacodynamic endpoints, and patient stratification
considerations. Contribute to the development and implementation of
an effective, timely, and cost-efficient program to establish the
safety and efficacy of drug candidates for approval in the US and
other countries. Collaborate across departments, including
Discovery, Clinical Operations, and external collaborators, to
ensure smooth transitions of development candidates from research
into clinical development, and oversee the execution of clinical
trials according to all applicable regulations and guidelines (GCP,
ICH). Identify, manage, and interface with external collaborators
and key opinion leaders to create clinical development strategies
for novel therapeutics. Provide clinical development oversight and
input, including writing and reviewing key documents such as
protocols, investigator brochures, and informed consent forms,
while ensuring the integration of product and clinical development
plans. Manage relationships with third parties such as CROs and
collaborative partners to support clinical development efforts and
implement chosen outsourcing or in-house approaches. Serve as a
medical representative to regulatory agencies, investigators,
advisors, and as study medical monitor, as needed, co-representing
the company in regulatory interactions. Guide the Research team on
decisions with clinical implications and support the writing of
protocols, presentations, publications, and regulatory submissions.
Develop and implement SOPs for clinical trials and ensure
compliance with all applicable regulatory standards for global
clinical trials and interactions with physicians. Provide
leadership and mentorship to clinical development team members,
manage matrix and direct line reports, and support the Clinical
Development Lead in oversight of the department budget and
financial planning. Maintain accountability for timelines and
deliverables by coordinating with internal departments (e.g.,
Finance, Regulatory Affairs, Legal, Medical Affairs) and external
vendors. Provide timely updates on progress and changes in scope,
schedule, and resources as needed. Participate in Business
Development due diligence and presentations to external
stakeholders. Develop and maintain professional relationships with
academic and community-based study sites. Education and Skills
Requirements: Doctor of Medicine degree, PhD, or Pharm. D., with a
strong scientific background and a specialty in neurology or
neuroscience training highly preferred Minimum of 12 years of
pharmaceutical industry experience, including leading clinical
development programs in Neurology/Neuromuscular disorders
Experience managing drug development from Phase 1 through Phase 3
trials Comprehensive experience with Pre-INDs, INDs, CTAs, EOP 2
meetings, NDA/BLAs/MAA submissions (both US and ex-US) Strong
knowledge of FDA and ICH regulations, along with expert knowledge
of Good Clinical Practice (GCP) Proven ability to design, execute,
monitor, and manage clinical trials across all phases of
development Readiness to contribute hands-on to team efforts and
inspire high-performance clinical teams Skilled in working in a
matrix environment, building consensus, and driving successful
outcomes across departments and stakeholders Ability to lead
cross-functional meetings and collaborate with senior leaders and
external stakeholders Ability to translate basic science into
product development plans that maximize commercial opportunity
Develop creative approaches to processes, practices, and strategies
Effectively prioritize near- to long-term efforts for impactful
results Exceptional writing and verbal communication skills, with a
proven track record of publications and polished presentations
Ability to effectively influence internal and external audiences
with clear communication Takes personal accountability for outcomes
and thrives on increasing levels of responsibility Consistently
drives key actions with independence and high effectiveness
Experience in a small to mid-sized biotech company preferred, with
demonstrated readiness to adapt and excel in dynamic environments
LI-Onsite The statements contained herein reflect general details
as necessary to describe the principles functions for this job, the
level of knowledge and skill typically required, and the scope of
responsibility, but should not be considered an all-inclusive
listing of work requirements. Individuals may perform other duties
as assigned, including work in other functional areas to cover
absences or relief, to equalize peak work periods or otherwise
balance workload. This description is not intended to be
constructed as an exhaustive list of duties, responsibilities, or
requirements for the position. This position may change or assume
additional duties at any time. The employee may be requested to
perform different or additional duties as assigned. All Employees
are expected to adhere to all company policies and act as a role
model for company values. Dyne Therapeutics is an equal opportunity
employer and will not discriminate against any employee or
applicant on the basis of age, color, disability, gender, national
origin, race, religion, sexual orientation, veteran status, or any
classification protected by federal, state, or local law.
Keywords: Dyne Therapeutics, Plymouth , Senior Director, Medical Director, Healthcare , Waltham, Massachusetts