Director, Development Operations
Department: 126 Clinical DevelopmentLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics 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) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Director, Development Operations is a highly organized and strategic member of the CMO organization, supporting the Chief Medical Officer (CMO) in the execution of key initiatives and operational priorities within the clinical development and broader medical organization. This role leads and coordinates the clinical development strategy for our product pipeline. This role is pivotal in the design, execution, and interpretation of clinical trials, ensuring compliance with regulatory guidelines and alignment with corporate objectives. The successful candidate will collaborate with cross-functional teams, including regulatory affairs, clinical operations, biostatistics, and external partners.This role demands a results-oriented leader with a strong background in clinical development, excellent communication skills, and the ability to manage cross-functional projects effectively
This role is based in Waltham, MA without the possibility of being fully remote.
Primary Responsibilities Include:
- Assist the CMO in the strategic planning and operational execution of clinical development programs and medical initiatives
- Manage the CMO’s agenda, prioritizing key meetings, presentations, and stakeholder engagements to optimize the effectiveness of their time
- Coordinate cross-functional collaborations between Clinical Development, Regulatory Affairs, Commercial, and other key departments to ensure alignment with corporate goals
- Prepare and review materials for internal and external meetings, ensuring clarity, alignment, and a focus on key objectives
- Serve as a point of contact for the CMO, facilitating communication and coordination across the organization and with external stakeholders
- Monitor progress on key projects and initiatives, providing updates and recommendations to the CMO and relevant teams as needed
- Support the development and implementation of team and departmental strategies, fostering a culture of excellence and innovation
- Lead special projects and initiatives as directed by the CMO, utilizing strong project management skills to drive results
- Assist in the preparation and management of budgets related to clinical development and medical affairs activities
- Partner to drive the timelines and coordination for the development and implementation of robust clinical development plans that align with the overall product strategy
- Coordinate to help the CMO organization to define clinical trial designs, endpoints, and study populations in collaboration with key stakeholders
Education and Skills Requirements:
- Bachelor’s degree in Life Sciences, Business Administration, or a related field; advanced degree (MBA, MD, or PhD) preferred
- Minimum of 8 years of experience in the biotechnology or pharmaceutical industry, with a focus on clinical operations, medical affairs, or related fields
- Demonstrated experience in project management and strategic planning, with the ability to manage multiple priorities in a fast-paced environment
- Strong analytical skills and attention to detail, with the ability to synthesize information and make data-driven decisions
- Exceptional communication and interpersonal skills, with a proven ability to build relationships across all levels of the organization
- Demonstrated leadership capabilities, with experience supporting senior executives or leadership teams
- Proficiency in MS Office Suite and project management tools
- Knowledge of clinical research practices, FDA/EMA regulations and ICH GCP Guidelines regarding drug development in all phases, and data management methods
- Familiarity with European GDPR legislation and managing emerging impact on clinical trial conduct
- NDA/BLA regulatory filing experience preferred
- Excellent communication and presentation skills
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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.
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