Senior Director, Medical Director Position Available In Middlesex, Massachusetts

Job Description:

Company Overview:

Dyne Therapeutics is discovering and advancinginnovative life-transforming therapeutics for people living withgenetically driven neuromuscular diseases. Leveraging themodularity of its FORCE™ platform, Dyne is developing targetedtherapeutics that deliver to muscle and the central nervous system(CNS). Dyne has a broad pipeline for neuromuscular diseases,including clinical programs for myotonic dystrophy type 1 (DM1) andDuchenne muscular dystrophy (DMD) and preclinical programs forfacioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary:

The Senior Director, Medical Director serves as a keymember of the DM1 clinical team leadership and has primaryresponsibility for the execution of the integrated developmentstrategy, including both in-house development and potentialstrategic partnerships to augment the internally developedpipeline. The Senior Director, Medical Director is responsible forthe development of the medical aspects of the program. This role isresponsible for delivering quality and timely medical input andinterpretation on specific program data in fulfilment of theprogram objectives, working in partnership with regulatory affairsand pharmacovigilance in providing medical support forpharmacovigilance activities, responses to regulatory agencyqueries, and development. This role is based in Waltham, MA withthe possibility of being a hybrid role.

Primary ResponsibilitiesInclude:

Partner with the DM1 Clinical Development Lead to guidethe Clinical Development team across the planning, design,development, and implementation of clinical trials for a drugcandidate. Develop knowledge of disease mechanisms to selectbiomarkers, pharmacodynamic endpoints, and patient stratificationconsiderations. Contribute to the development and implementation ofan effective, timely, and cost-efficient program to establish thesafety and efficacy of drug candidates for approval in the US andother countries. Collaborate across departments, includingDiscovery, Clinical Operations, and external collaborators, toensure smooth transitions of development candidates from researchinto clinical development, and oversee the execution of clinicaltrials according to all applicable regulations and guidelines (GCP,ICH). Identify, manage, and interface with external collaboratorsand key opinion leaders to create clinical development strategiesfor novel therapeutics. Provide clinical development oversight andinput, including writing and reviewing key documents such asprotocols, investigator brochures, and informed consent forms,while ensuring the integration of product and clinical developmentplans. Manage relationships with third parties such as CROs andcollaborative partners to support clinical development efforts andimplement chosen outsourcing or in-house approaches. Serve as amedical representative to regulatory agencies, investigators,advisors, and as study medical monitor, as needed, co-representingthe company in regulatory interactions. Guide the Research team ondecisions with clinical implications and support the writing ofprotocols, presentations, publications, and regulatory submissions.

Develop and implement SOPs for clinical trials and ensurecompliance with all applicable regulatory standards for globalclinical trials and interactions with physicians. Provideleadership and mentorship to clinical development team members,manage matrix and direct line reports, and support the ClinicalDevelopment Lead in oversight of the department budget andfinancial planning. Maintain accountability for timelines anddeliverables by coordinating with internal departments (e.g.,Finance, Regulatory Affairs, Legal, Medical Affairs) and externalvendors. Provide timely updates on progress and changes in scope,schedule, and resources as needed. Participate in BusinessDevelopment due diligence and presentations to externalstakeholders. Develop and maintain professional relationships withacademic and community-based study sites.

Education and SkillsRequirements:

Doctor of Medicine degree, PhD, or Pharm. D., with astrong scientific background and a specialty in neurology orneuroscience training highly preferred Minimum of 12 years ofpharmaceutical industry experience, including leading clinicaldevelopment programs in Neurology/Neuromuscular disordersExperience managing drug development from Phase 1 through Phase 3trials Comprehensive experience with Pre-INDs, INDs, CTAs, EOP 2meetings, NDA/BLAs/MAA submissions (both US and ex-US) Strongknowledge of FDA and ICH regulations, along with expert knowledgeof Good Clinical Practice (GCP) Proven ability to design, execute,monitor, and manage clinical trials across all phases ofdevelopment Readiness to contribute hands-on to team efforts andinspire high-performance clinical teams Skilled in working in amatrix environment, building consensus, and driving successfuloutcomes across departments and stakeholders Ability to leadcross-functional meetings and collaborate with senior leaders andexternal stakeholders Ability to translate basic science intoproduct development plans that maximize commercial opportunityDevelop creative approaches to processes, practices, and strategiesEffectively prioritize near- to long-term efforts for impactfulresults Exceptional writing and verbal communication skills, with aproven track record of publications and polished presentationsAbility to effectively influence internal and external audienceswith clear communication Takes personal accountability for outcomesand thrives on increasing levels of responsibility Consistentlydrives key actions with independence and high effectivenessExperience in a small to mid-sized biotech company preferred, withdemonstrated readiness to adapt and excel in dynamic environmentsLI-Onsite The statements contained herein reflect general detailsas necessary to describe the principles functions for this job, thelevel of knowledge and skill typically required, and the scope ofresponsibility, but should not be considered an all-inclusivelisting of work requirements. Individuals may perform other dutiesas assigned, including work in other functional areas to coverabsences or relief, to equalize peak work periods or otherwisebalance workload. This description is not intended to beconstructed as an exhaustive list of duties, responsibilities, orrequirements for the position. This position may change or assumeadditional duties at any time. The employee may be requested toperform different or additional duties as assigned. All Employeesare expected to adhere to all company policies and act as a rolemodel for company values. Dyne Therapeutics is an equal opportunityemployer and will not discriminate against any employee orapplicant on the basis of age, color, disability, gender, nationalorigin, race, religion, sexual orientation, veteran status, or anyclassification protected by federal, state, or local law.