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Director, Global Medical Affairs Lead

4 months ago

Waltham, United States BioSpace Full time
Job Details

Company Overview:
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

Role Summary:

The Global Medical Affairs Lead (GMAL) serves a critical role by supporting Dyne's Neuromuscular Disease programs (NMD). Internally, the GMAL is accountable as the Global Medical Affairs representative on key cross-functional, and highly visible teams including Program Development Teams, Clinical Development sub-teams, and eventually Brand Teams. In addition, the GMAL is expected to master the scientific and medical literature/data associated with the FORCE platform, as well as the NMD therapeutic areas of focus, and support efforts to enhance and communicate Dyne's scientific leadership. The person in this role plays a key role in congress, symposia, and publication strategy. Externally, the GMAL leads the development and execution of the strategy around key opinion leader (KOL) engagement, advisory boards, and expert committees. The GMAL is also closely partnered with their counterparts in clinical development/operations and new product planning to ensure cohesive trial site engagement plans, TPP development, Payer engagement plans, etc. The role also interfaces with Dyne's partners in the development of partnered assets should that be required.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:
  • Serve as a medical subject matter expert on ASOs and other therapeutic modalities for our NMD programs
  • Serve as internal expert on medical literature / data associated with our NMD programs
  • Represent GMA on cross-functional teams supporting assets in the pipeline
  • Develop and execute the global medical plans in line with overall Corporate and Product strategies and priorities
  • Partner closely with new product planning to develop and drive commercial plans and tactics, patient identification efforts, and patient journey mapping
  • Partner closely with regional medical teams to ensure they have the resources required to engage with KOLs, payers and the community, and to facilitate a system of sharing insights gathered in the regions to support global strategy
  • Collaborate closely with clinical development, clinical operation, and regulatory affairs teams to support clinical trial planning, execution, site engagement, and interpretation of clinical data for Dyne's NMD programs
  • Collaborate with cross-functional teams to support the development of medical research strategy to assess data gaps including pre-clinical/non-clinical to generate sound clinical and scientific evidence to accelerate clinical adoption with HCPs and Payers
  • Support congress, symposia and ad board strategy development and creation of content.
  • Lead the development and execution of the KOL and Payer engagement strategy including mapping landscape, outreach plans, insight gathering and reporting, and relationship management for Dyne's NMD programs
  • Develop deep understanding of the diagnostic challenges for these therapeutic areas
  • Acts as role model of integrity and compliance

Education and Skills Requirements:
  • Doctorate degree (MD, PhD, PharmD) with a minimum of 10 years of experience with a focus on rare diseases, neuromuscular experience, or related discipline
  • Experience with ASOs preferred
  • At least 4 years of relevant experience in rare diseases; neuromuscular or related field preferred
  • Analytical, with a track record of delivering against goals while working in high performing, diverse teams
  • Demonstrated success in operating effectively in highly matrixed organizations where influencing skills are critical to day-to-day success
  • Ability to quickly adapt to new disease areas or therapeutic modalities
  • Experience in building strong and effective relationships with thought leaders, and healthcare professionals, including laboratory professionals
  • Articulate with excellent communication and influencing skills
  • Travel up to ~20%

#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.