Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role

Dyne is seeking an experienced clinical operations leader for the newly created role of Vice President, Clinical Operations, accountable for the resourcing, development, training, and management of a highly performing clinical operations team, and strategic oversight and execution (within budget and timelines) of clinical plans. A successful candidate must thrive in a fast-paced environment where flexibility, accountability, and teamwork are paramount, and share a passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases. Additionally, this individual must have excellent interpersonal skills and be able to analyze complex issues to develop strategies to successfully implement clinical trial plans. This position reports to the Senior Vice President, Clinical Development.

Primary Responsibilities Include:

• Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs.
• Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues.
• Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators.
• Ensure high standards for compliance and quality within the Clinical Operations team and across clinical trial vendors with company SOPs, ICH-GCP guidelines that govern regulations, and patient safety standards.
• Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions.
• Provide strategic input to clinical-trial related risk analysis and mitigation strategies.
• Provide operations input into trial-related documentation and regulatory submissions.
• Lead the development and review of clinical program budgets, and track and forecast spend for initiated studies.
• Lead authorship of Clinical Operations SOPs and other function-specific documentation.
• Recruit, mentor and develop Clinical Operations staff.

Education and Skill Requirements:

• BS/BA in a scientific discipline with at least 20 years of relevant clinical operations experience; or, MS or PhD in a scientific discipline and 15 years of relevant clinical operations experience.
• Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies.
• Experience implementing clinical trial management systems, including TMF, EDC, IXRS.
• Experience running global clinical trials from initial feasibility through to CSR delivery.
• Detailed 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.
• Experience running trials in rare disease preferred.
• NDA/BLA regulatory filing experience preferred.
• Excellent communication and presentation skills.

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role

We are seeking a Director, Regulatory Affairs to help drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs. A successful candidate must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases is a must.

Primary Responsibilities Include:

• Interacts with other departments to develop regulatory strategy and submission plans for quality and timely filings.
• As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
• Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
• Manage timelines and preparation of meeting requests and briefing documents.
• Author/edit documents to support regulatory submissions.
• Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Support the organization with health authority meetings.
• Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).
• Manage staff and vendors as needed to support regulatory activities.
• Assist with SOP generation.
• Perform other duties as required, interfacing with other departments, CROs and external vendors as needed

Education and Skill Requirements:

• Minimum of a bachelor’s degree in life science or related discipline is required
• Minimum of 5-8 years of experience in regulatory strategy in a clinical-stage biotechnology company
• Strong experience with CTD format and content regulatory filings
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Experience in Health Authority Meetings
• Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
• Ability to work independently to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
• Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management
• Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned

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.