Role Summary:

The Data Sciences team at Dyne Therapeutics is seeking an exceptional Co-Op candidate to contribute to development of machine learning (ML) and AI-driven tools for our R&D programs. The primary focus will be on refining molecular sequence-based ML models for property/activity prediction. This includes working with sequence, structural, and contextual features to enhance model performance and generalizability.

In addition, the Co-Op will contribute to development of LLM-based pipelines for scientific document drafting and evaluation, including retrieval-augmented generation (RAG) workflows to support internal research and regulatory processes.

This role provides hands-on experience at the intersection of computational biology and applied AI, directly supporting team priorities in molecular optimization, pipeline expansion, and AI capability development.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university.

 
Primary Responsibilities Include: 

• Support data curation, preprocessing, and feature generation for biomolecular sequence ML models.
• Assist with model training, evaluation, and benchmarking under guidance.
• Contribute to development and testing of LLM-based document drafting and verification pipelines.
• Deliver well-documented and reproducible code, analysis summaries, and a final presentation of contributions.

 Education and Skills Requirements: 

• Undergraduate or Graduate student currently pursuing a degree in bioinformatics, Computational biology, or computer science or equivalent experience. Must be in active student status during duration of Co-Op program.
• Demonstrated competency in python and/or R programming skills.
• Prior experience in data science, AI, or machine learning is preferred.
• Strong organizational skills and solid written and oral communication ability.

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Role Summary:

Dyne is seeking a motivated Co-op student to support the early drug discovery team. The Dyne Co-op program offers students the opportunity to learn about the biotech industry while performing hands-on projects. The student will join a team of chemists and biologists and interact with laboratory colleagues in a cross-functional setting. Working with a mentor, the student will learn to design, perform, and interpret various cell-based assays to enable the discovery of new therapeutics for genetic-based muscle diseases.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Learn diverse lab techniques such as mammalian cell culture, including maintenance of iPSC-derived cells, qRCR, capillary electrophoresis, flow cytometry, and ELISA.
• Learn the principles of receptor-mediated drug delivery and apply them experimentally.
• With coaching from your mentor, you will learn to plan an independent project, evaluate relevant literature, optimize a protocol, conduct experiments, and communicate results to the team.
• Learn to maintain clear, accurate records of experiments.
• At the end of the program, you will present a summary of the project to the company.

Education and Skills Requirements:

• Currently enrolled in an undergraduate/ graduate program in a life science track.
• Interest in muscle cell biology and drug discovery.
• Understanding of biochemical and cell biology principles.
• Previous experience with mammalian cell culture and maintenance is a plus.
• Familiarity with software such as Excel and PowerPoint.
• Attention to detail and ability to multitask.
• Strong communication skills.

Role Summary:

Dyne is seeking a highly motivated Co-Op student to support process development in the Platform Development team. Dyne’s Co-Op program offers students the opportunity to learn and work at a cutting-edge company in the biotech industry. This is an exceptional opportunity for students to be exposed to many facets of the company and learn about drug discovery from Dyne’s muscle disease programs. The student will join a team of chemists and biologists and interact cross-functionally and collaboratively with scientists within the company. The student will work closely with mentors to develop skills in synthesis, purification, and characterization of therapeutic conjugates and their development through the research pipeline. The successful candidate will be collaborative, detail-oriented, motivated, enjoy learning new skills, and working in a fast-paced environment.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Learn diverse lab techniques, including buffer preparation, SDS-PAGE, BCA, ELISA, and AKTA to support biological conjugations.
• Learn and assist biochemical analysis and interpretation on in-process and final purified conjugates using in-house analytical methods across instruments such as UPLC-RP/SEC, LC-MS/MS.
• Maintain accurate and clear records of experimental work.
• Communicate up-to-date findings and contribute to critical discussions with the group members.
• Present a summary of learnings and findings to the team at the end of the Co-Op program.

 Education & Skill Requirements:

• Currently enrolled in an undergraduate/ graduate program with a background in biology, chemistry, or a related track with at least one year of experience of general chemistry lab work (eg, molarity calculation, pipetting).
• Ability to follow experimental protocols and take the initiative to learn new skills.
• Good interpersonal skills, able to maintain positive working relationships with co-workers, and to work cooperatively with peers.
• Hands-on academic/ industry experiences with protein chemistry are desired.
• The candidate will be self-motivated and detail-oriented and have the ability to communicate ideas and document research effectively.

Role Summary:
Dyne is seeking a co-op for the Oligonucleotide Chemistry team who is passionate about research and excited to participate in finding cures for rare diseases with unmet needs. This Co-Op will focus on RNA therapeutics at the intersection of chemistry and biology, with a particular emphasis on synthesizing oligonucleotides (short DNA and RNA analogs) able to turn off the expression of disease-causing genes. This work will help us enhance our growing pipeline driving innovation and accelerating development of new therapies.

The Oligonucleotide Chemistry team falls within the broader Platform Development team and cultivates an environment of versatility and transparency, therefore excellent communication skills are required. The Co-Op will learn key aspects of RNA therapeutics and to chemically synthesize and characterize oligonucleotides to support research in this emerging field.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July. 

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Perform solid phase synthesis of chemically modified oligonucleotides at various scales to support in vitro and in vivo experiments.
• Perform purification of oligonucleotides to achieve high purity standards.
• Perform analysis (HPLC/UPLC), and characterization (LCMS, UV, melting temperature) of oligonucleotides and their conjugates.
• Multi-task across several projects.
• Gather data, create compelling slides, and present findings in group meetings.
• Eagerness to learn key aspects of RNA therapeutics and to synthesize oligonucleotides to support this research.

Education and Skills Requirements:

• Currently enrolled in a Bachelors, Masters, or PhD program in Biochemistry, Organic Chemistry or related fields.
• Prior lab experience highly
• Background/coursework in chemistry, biochemistry, organic chemistry, and analytical chemistry required.
• General knowledge of DNA/RNA structure and function is a plus but not required.
• Knowledge of software applications using Microsoft Office Skills (PowerPoint, Word, Excel).
• Strong communication skills and willingness to collaborate with team.

Role Summary:

The Co-op for Genetics Medicine Research will provide critical lab-facing support towards the development of exciting novel therapies for the treatment of cardiac disorders. This role will support key in vitro and in vivo studies aimed at evaluating mechanisms of action and efficacy of our therapeutic molecules. Co-op in this role will onboard a number of critical molecular assays that drive go/no-go decisions for drug development and communicate these findings to the department and wider company. As part of the Dyne research team, this role requires a highly motivated, collaborative team player and ambitious self-starter who enjoys working in a fast-paced team setting.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

 Primary Responsibilities Include:

• Execute assays following established protocols to evaluate therapeutic candidates in relevant biological systems.
• Support development of new assays to answer key scientific questions to drive program forward.
• Document research efforts and maintain proper records.
• Process animal tissues for downstream assays.
• Work effectively with cross-functional teams to deliver high-quality results.
• Perform data analysis and communicate findings to team members.
• Follow general laboratory safety procedures, as related to biologically derived materials.
• Present research findings at departmental and company-wide meetings.

 Education and Skills Requirements:

• Undergraduate or Graduate student currently pursuing a degree in biology or neuroscience discipline.
• Experience with executing tissue culture and core molecular biology assays: qPCR, hELISA, FISH, etc. is desired.
• Self-motivated team player with a strong work ethic.
• Exceptional attention to details and organizational skills.
• Excellent communication skills and diligent with record keeping.
• Knowledge of software applications such as Prism, Excel, and PowerPoint.

Role Summary:

The Co-op for Genetics Medicine Research will provide critical lab-facing support towards the development of exciting novel therapies for the treatment of neuromuscular disorders. This role will support key in vitro and in vivo studies aimed at evaluating mechanisms of action and efficacy of our therapeutic molecules. The Co-op in this role will onboard a number of critical molecular assays that drive go/no-go decisions for drug development and communicate these findings to the department and wider company. As part of the Dyne research team, this role requires a highly motivated, collaborative team player and ambitious self-starter who enjoys working in a fast-paced team setting. Co-op must be comfortable with hands-on mouse tissue processing for consideration.

This role is based in Waltham, MA without the possibility of being remote. This is a 6-month position beginning in July.  

Candidates must be enrolled in an accredited college or university Co-Op Program.

Primary Responsibilities Include:

• Execute assays following established protocols to evaluate therapeutic candidates in relevant biological systems.
• Support development of new assays to answer key scientific questions to drive program forward.
• Document research efforts and maintain proper records.
• Process animal tissues for downstream assays.
• Work effectively with cross-functional teams to deliver high-quality results.
• Perform data analysis and communicate findings to team members.
• Follow general laboratory safety procedures, as related to biologically derived materials.
• Present research findings at departmental and company-wide meetings.

Education and Skills Requirements:

• Undergraduate or Graduate student currently pursuing a degree in biology or neuroscience discipline.
• Experience with executing tissue culture and core molecular biology assays: qPCR, hELISA, FISH, etc. is desired.
• Self-motivated team player with a strong work ethic.
• Exceptional attention to details and organizational skills.
• Excellent communication skills and diligent with record keeping.
• Knowledge of software applications such as Prism, Excel, and PowerPoint.

Role Summary:

The Senior Director of Managed Access Programs (MAPs) leads the strategic direction and operational execution of managed access initiatives across the organization. This role is crucial in designing, implementing, and managing global programs that ensure patient access to our innovative therapeutics. This role develops policies and procedures that support equitable access while adhering to regulatory standards. This position collaborates closely with internal teams, including market access, HEOR, medical affairs, commercial, clinical, regulatory, supply chain, legal, and compliance to align MAP initiatives with the overall goals of the organization.

In addition, the person in this role partners with cross-functional teams to build and maintain strong relationships with key external stakeholders, to promote understanding and support for managed access programs. With a focus on data-driven decision-making, this role analyzes program performance, adjusting strategies as needed to maximize impact. By providing training and support to internal teams, this role ensures effective implementation of MAPs initiatives across the organization. Ultimately, this role plays a vital part in navigating complex access environments and improving health outcomes for patients.

This role is based in Waltham, MA.

Primary Responsibilities Include:

• Provide visionary leadership in the development and execution of managed access programs, ensuring that strategies align with Dyne Therapeutics' mission and objectives
• Build and oversee infrastructure necessary to implement managed access programs
• Oversee vendor responsible for program administration
• Foster a culture of collaboration and innovation within organization, guiding teams in effectively addressing patient needs and access challenges
• Design and implement comprehensive managed access policies and procedures that promote patient access to innovative therapies, with an emphasis on maintaining compliance with evolving regulatory requirements
• Utilize best practices and learnings from the field to continuously refine and enhance program frameworks
• Lead cross-functional teams, including Clinical Development, Regulatory Affairs, and Commercial, to ensure successful integration of managed access strategies across all stages of product development and commercialization
• Act as a key liaison, facilitating clear communication and alignment on priorities and objectives
• Establish and cultivate strong relationships with a diverse range of external stakeholders, including healthcare professionals, patient advocacy organizations, and regulatory bodies as appropriate
• Represent Dyne Therapeutics at conferences, meetings, and roundtable discussions, effectively advocating for managed access initiatives and fostering stakeholder trust and support
• Partner with HEOR, Market Access, Medical Affairs, and Clinical Development to implement data collection and analytics methodologies to assess program efficacy, patient outcomes, and potential access barriers
• Generate and present comprehensive reports to senior leadership and external stakeholders, offering actionable insights and recommendations for program improvement
• Develop and deliver targeted training programs and resources for internal teams regarding managed access processes, regulatory compliance, and best practices
• Ensure team is well-equipped to effectively engage with external partners and navigate complex access scenarios
• Continuously monitor and analyze industry trends, regulatory changes, and market dynamics that impact managed access programs
• Provide strategic recommendations to adapt and evolve Dyne Therapeutics' approach to access challenges in response to the shifting landscape
• Oversee the financial aspects of managed access programs, including budget planning, forecasting, and resource allocation
• Ensure that objectives are met while maximizing the impact of programs on patient access initiatives
• Foster a culture of excellence by encouraging feedback and facilitating continuous improvement within managed access programs
• Utilize lessons learned from program implementation and stakeholder interactions to drive innovation and enhance the overall effectiveness of initiatives

Education and Skills Requirements:

• Bachelor’s degree with rare disease experience in the biotech and/or pharmaceutical industry; neuromuscular experience preferred
• 15+ years of relevant experience in Medical Affairs and experience in leading global Managed Access Programs within the pharmaceutical/biotech industry; clinical operations experience also desirable
• Proven ability to lead global Managed Access Program development and implementation
• Excellent communication and relationship-building skills with KOLs and cross-functional teams
• Experienced in AI supported way of working
• Ability to interpret and communicate complex scientific data to diverse audiences
• Must be willing to travel up to 30%, inclusive of overnight and occasional weekends, to meet with customers, internal stakeholders and attend relevant conferences
• In-depth understanding of healthcare regulations, access environments, and the pharmaceutical industry landscape
• Familiarity with rare diseases and innovative therapies is highly desirable
• Strong leadership and interpersonal skills, with the ability to influence and drive cross-functional collaboration
• Excellent analytical and problem-solving capabilities.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly to diverse audiences (written, verbal and presentation)
• Proven track record of developing and executing successful managed access strategies that improve patient access and outcomes
• Excellent team player
• Strong decision maker
• Ability to work in a matrix environment
• Ability to work independently as a hands-on manager, proactively contribute as a resource when necessary
• Flexibility to adapt and meet the changing/growing needs of our customers
• High level of integrity, compliance, ethics, and transparency
• Positive team member who embodies Dyne’s Core Values
• Excitement about Dyne’s vision and mission

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Role Summary:

The Senior TMF Specialist supports the ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. This role is responsible for the integrity, completeness and compliance of our TMF including accurate filing, tracking, and quality control of TMF documents in accordance with ICH-GCP, the TMF Reference Model, and company procedures. This role requires a deep understanding of regulatory requirements and industry best practices related to TMF management in order to support our clinical trials effectively. This role partners closely with Clinical Operations, Quality, Regulatory and external partners to ensure timely document collection and a complete, inspection-ready TMF. 

This role is based in Waltham, MA.  

Primary Responsibilities Include: 

TMF Operations & Maintenance 

• Participate in the creation, maintenance, and management of the TMF for clinical studies, ensuring compliance and regulatory standards (e.g., ICH, FDA) and internal policies 

• Develop and implement TMF-related processes and procedures to ensure timely and accurate documentation of all trial-related activities  

• Support day-to-day TMF activities for assigned studies, including filing, indexing, and quality control of documents within the eTMF system 

• Ensure accurate, complete, and timely filing of TMF documentation in accordance with applicable SOPs, TMF Reference Model, and regulatory requirements 

• Perform routine TMF completeness and quality checks, identifying missing, incorrect, or misfiled documents 

• Track document deliverables and follow up with study teams, CROs, and vendors to resolve gaps 

TMF Quality & Inspection Readiness 

• Support ongoing TMF health assessments and inspection readiness activities 

• Assist with TMF-related audit and inspection preparation, including document reconciliation and retrieval, to assess completeness and quality, identifying any gaps and implementing corrective actions as necessary  

• Document TMF issues, deviations, or quality observations and support corrective actions as needed 

Participate in TMF inspections and audits by regulatory authorities and serve as a contact for TMF-related queries Process Adherence & Continuous Improvement 

• Adhere to company TMF processes, SOPs, and work instructions 

• Identify opportunities for process improvement, standardization, or increased efficiency and escalate recommendations as appropriate 

• Support TMF process updates, system enhancements, and user acceptance testing as needed 

Training & Documentation Support 

• Support onboarding and training of internal team members and vendors on TMF processes, eTMF system usage, and best practices  

• Maintain TMF-related trackers, logs, and study documentation as required 

• Stay current with industry trends and regulatory changes impacting TMF management  

Vendor & Technology Management: 

• Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements 

• Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF 

• Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices  

Cross Functional Partnership & Support: 

• Collaborate with Clinical Operations, Quality, Regulatory, and external partners to support TMF expectations and timelines 

• Serve as a TMF point of contact for assigned studies, answering procedural and process-related questions 

Education and Skills Requirements: 

• Bachelor’s degree in life sciences or a related field  

• 6+ years of experience in clinical operations, TMF management, document management, or a regulated GxP environment  

• Strong knowledge of regulatory requirements and guidelines governing TMF maintenance and management, ICH-GCP, TMF Reference Model, and clinical trial documentation requirements  

• Proven hands-on experience with eTMF systems, document management software, and document quality control  

• Excellent organizational skills and ability to work independently as well as collaboratively in a fast-paced environment 

• Experience working with eTMF systems and CRO/vendor oversight 

• Excellent communication (written and verbal), influencing, and stakeholder management skills 

• Ability to interact effectively with cross-functional teams and external stakeholders at all levels of the organization  

• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment 

• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations 

• Demonstrated ability to influence cross-functional stakeholders without direct authority 

• Highly collaborative team player with a strong cross-functional mindset 

• Meticulous attention to detail with a commitment to quality and compliance 

• Positive, proactive, and resilient team member who embodies Dyne’s Core Values  

• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases 

• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 

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Role Summary:

The Associate Director, Omnichannel Enablement will be a critical leader in building and scaling Dyne’s omnichannel capability to support disease area readiness, launch excellence, and sustained commercial growth.

This role will be accountable for bringing omnichannel strategy to life through the hands-on design and implementation of customer journeys, modular content frameworks, and activation models that enable coordinated, personalized, and insight-driven engagement across channels.

The Associate Director will work directly with brand teams and enabling functions to translate strategy into practical execution—designing journeys, shaping content approaches, and embedding omnichannel ways of working into day-to-day operations. This role will partner closely with Commercial Strategy, Brand Marketing, Commercial Insights & Analytics, Field Excellence, IT/Digital, and external partners to ensure omnichannel is delivered as a scalable, repeatable capability.

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

Primary Responsibilities Include:

• Lead the design, implementation, and continuous evolution of Dyne’s omnichannel enablement framework, including ways of working, governance, and operational models aligned to brand and portfolio needs.
• Design and operationalize end-to-end customer journeys across personal, digital, and non-personal channels, including channel roles, sequencing, and orchestration, leveraging analytics and AI to inform targeting, timing and personalization.
• Partner with Brand Marketing to bring modular content strategies to life, enabling efficient content reuse, personalization, and activation across channels, including thoughtful application of AI and AI-enabled tools to accelerate content development, adaption and deployment.
• Translate omnichannel strategy into practical tools, playbooks, templates, and standards that allow brand and field teams to plan, activate, and optimize omnichannel engagement.
• Work hands-on with brand teams during brand planning, campaign development, and launch preparation to embed omnichannel thinking from the outset.
• Serve as a strategic connector between enabling functions (e.g., Commercial Insights & Analytics, Operations, IT/Digital) to ensure integrated execution and consistent customer experiences.
• Define and operationalize standards for personalization, audience targeting, content deployment, and cross-channel measurement.
• Lead enablement efforts for omnichannel capabilities, including training, onboarding, and change management for brand teams and field-facing roles.
• Establish learning agendas, measurement frameworks, and feedback loops in partnership with Commercial Insights & Analytics to drive optimization and continuous improvement.
• Ensure omnichannel execution aligns with compliance, legal, and regulatory requirements, partnering closely with appropriate stakeholders.
• Identify, pilot, and scale new omnichannel tools, capabilities, and processes that advance Dyne’s omnichannel maturity over time, including evaluation of emerging technologies such as AI-enabled platforms.
• Act as a hands-on thought partner and subject matter expert, helping shape Dyne’s long-term commercial operating model and omnichannel roadmap.

Education and Skills Requirements:

• Bachelor’s degree required; advanced degree (MBA or equivalent) preferred.
• 8+ years of experience in commercial, omnichannel, digital, or marketing enablement roles within biotech, pharmaceutical, or life sciences organizations.
• Demonstrated experience designing and activating omnichannel journeys, content strategies, or engagement models in a launch or growth-stage environment.
• Strong understanding of life sciences commercial ecosystems, including brand strategy, field engagement models, digital channels, and data-driven decision making.
• Experience working hands-on with brand teams to translate strategy into execution across multiple channels.
• Experience leveraging data, analytics and emerging technologies (including AI-enabled tools) to enhance customer experience, content and omnichannel execution.
• Proven ability to work cross-functionally and influence without authority in a matrixed organization.
• Strong communication, facilitation, and change leadership skills.
• Ability to balance strategic thinking with hands-on design and implementation in a fast-paced, evolving environment.

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Role Summary:

The Associate Director, Patient Advocacy & Operations works as part of the Corporate & Patient Affairs (C&PA) team with two key areas of focus: 1) Cultivating and supporting strategic partnerships with patient advocacy organizations and 2) day-to-day management of key Patient Advocacy and Corporate Affairs operations.

Reporting to the VP, Patient Advocacy, this role is highly integrated with internal cross-functional teams and partners with external organizations.

This role is based in Waltham, MA and does not offer a remote option. 

Primary Responsibilities: 

• In collaboration with the VP of Patient Advocacy, partner closely with advocacy leaders and the broader patient community to advance key initiatives, including but not limited to:
  • Executing the patient advocacy strategy in alignment with corporate objectives
  • Fostering strong, strategic relationships with patient leaders, caregivers, and advocacy organizations to inform company programs and priorities.
  • Leading the planning and management of Patient Community Advisory Panels/Boards.
  • Conducting one-on-one engagements with patient advocacy leaders to identify‑ needs, insights, and opportunities for collaboration.
  • Supporting clinical trial awareness and recruitment efforts through patient engagement and community focused‑ initiatives.
  • Collaborating with Medical Affairs, Marketing, Market Access/Patient Services, and Corporate Affairs to integrate the patient voice into R&D, clinical trial design, and commercialization efforts.
  • Representing Dyne at patient advocacy events, conferences, and advisory boards.
  • Collecting, synthesizing, and sharing patient community insights across functional teams.
  • Identifying and coordinating community participants for Dyne-led events (internal and external).

• Partner with the VP of Patient Advocacy to plan and execute conference and patient advocacy organization (PAO) engagement activities:
  • Supporting Dyne’s presence at patient advocacy and select scientific/medical conferences including event planning, session development, patient-facing materials, symposia, presentations, and on-site event execution.
  • Staffing events; willingness to travel approximately 20%.
• Serve as the operational lead for the Patient Advocacy Grants, Sponsorships & Donations committee, including budget oversight and end-to-end management of the submission process, such as coordinating with requestors, ensuring proper documentation, and overseeing contracting and payment workflows.
• Support the planning and execution of enterprise-wide events (e.g., advocacy walks) that bring patient community voices into the organization, serving as a Patient Advocacy representative on cross functional teams and supporting coordination tasks when needed. to support the delivery of high-quality experiences.
• Manage and own patient engagement–related contracting, ensuring compliance and timely execution.
• Lead operational processes for advancing patient advocacy materials through Medical Legal Review (MLR), ensuring accuracy, alignment, and compliance.

Education and Skills Requirements:

• Bachelor’s degree in a relevant field and a minimum of 8+ years of related experience (social work, genetic counseling, nursing, public health preferred). 
• 6+ years of experience in patient advocacy in the biotech/pharmaceutical industry, preferably within a clinical stage biotechnology company.
• Proven experience developing and sustaining partnerships with patient advocacy organizations and community leaders.
• Deep understanding of rare diseases and the unique needs of rare disease communities.
• Strong understanding of the Patient-Focused Drug Development (PFDD).
• Exceptional communication, diplomacy, and cross-functional collaboration skills.
• Experience managing budgets, teams, and compliance sensitive partnerships within a regulated environment.
• Proven experience partnering with clinical teams on trial awareness and recruitment efforts.
• Broad knowledge of the biopharma landscape and a solid working understanding of the drug development process.
• Strong interpersonal skills with the ability to influence without authority and work effectively across diverse functions and personalities.
• Compassionate, patient centered mindset, and a high degree of personal integrity.
• Ability to manage multiple simultaneous projects, navigate ambiguity, and thrive in a fast paced, dynamic environment.
• Experience with Patient Advocacy sponsorship contracting processes.
• Proven operations experience and excellent project, vendor, and budget management capabilities with a demonstrated ability to deliver results.
• Strong organizational skills and attention to detail.
• Bilingual fluency in Spanish is a plus.
• Overnight travel will be required; up to 20%.

Role Summary:

The Principal Scientist, Toxicology is a key member of preclinical development teams and is responsible for the strategic planning and execution of nonclinical safety plans for Dyne’s portfolio programs, supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. The role applies an in-depth understanding of regulatory guidance related to nonclinical development and designs, oversees, and critically evaluates exploratory and GLP-compliant toxicology studies. The Principal Scientist authors and reviews nonclinical regulatory documents and participates in interactions with regulatory authorities.

This is a full-time position based in Waltham, MA

Primary Responsibilities:

• Represent toxicology on program teams, providing expertise and guidance from discovery through development.
• Design and execute nonclinical safety plans for Dyne candidate therapeutics.
• Serve as the principal contact to external CROs executing these studies, ensuring studies are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO and GLP).
• Interpret toxicology data and communicate results to program teams and senior management.
• Write submission-ready documentation and appropriate toxicology content of regulatory submissions.
• Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
• Relevant board certification preferred.
• Demonstrated expertise in nonclinical safety assessment and the ability to provide scientific leadership across development programs.
• Experience designing, managing, and overseeing nonclinical toxicology studies, including work conducted at contract research organizations.
• Strong understanding of regulatory requirements governing nonclinical safety, with experience ensuring compliant study execution and documentation.
• Proven ability to interpret and critically evaluate toxicology data and author or review high-quality study reports and regulatory documentation.
• Ability to anticipate, assess, and address nonclinical safety and regulatory risks in complex development environments.
• Experience applying or advancing toxicological methods, technologies, or approaches.
• Experience assessing toxicity of antibody-drug conjugates and or oligonucleotide-based therapeutics is a plus.
• Expertise in immunology or immunotoxicology is a plus.
• Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts to cross-functional stakeholders.
• Demonstrated ability to work effectively in a collaborative, fast-paced environment while managing multiple priorities and timelines.

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Role Summary:

The Senior Principal Scientist, ADME/PK leads preclinical PK and ADME strategy for Dyne’s drug candidates, serving as the ADME‑PK subject matter expert on discovery and program teams. This role designs and executes internal and external studies, develops translational PK and modeling approaches to support clinical dose projections, and partners cross‑functionally to advance programs from discovery through clinical development. The position authors regulatory submissions, defines science‑based ADME strategies aligned with regulatory expectations, and communicates findings through high‑quality written and verbal scientific outputs.

This role is based in Waltham, MA and does not offer a remote option. 

Primary Responsibilities:

• Design and execute internal/external preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of Dyne’s drug candidates.
• Represent PCD as the ADME-PK subject matter expert on discovery and program teams.
• Partner with and support Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management and other Dyne departments.
• Collaborate with Clinical Pharmacology/Pharmacometrics to develop quantitative tools to translate PK/PD relationship from preclinical to clinical.
• Develop PK/PD, QSP, PBPK, or other appropriate models to capture preclinical data, enable clinical scaling and first in human dose projection.
• Author high quality Regulatory documents including INDs, CTAs, and NDA/BLA filings.
• Prepare strategic and science-based ADME strategies that meet regulatory requirements and program goals.
• Identify relevant ADME/PK endpoints for incorporating into early-stage compound design and prioritization.
• Facilitate strategic scientific communication via meetings, abstracts and manuscripts.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and minimum of 12+ years related experience.
• Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamics and bioanalytical principles.
• Familiarity with regulatory submission including FIH dosing strategy is highly desirable.
• Proficient in using WinNonlin or other pharmacokinetic software for non-compartmental analysis.
• PK/PD modeling experience.
• Excellent communication (verbal and written) and presentation skills, as well as interpersonal skills and the ability to represent PCD in a team environment.
• Experience with PK characterization of protein therapeutics or antibody-drug conjugates (ADCs) is desired.
• Understanding PK and modeling requirements for subcutaneous administration of biologics is desired.

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Role Summary:

The Director, Business & Operations – US Affiliate will serve as a key strategic and operational partner to the SVP, Head of US Affiliate, supporting the effectiveness, execution, and scalability of the US Affiliate organization. This role will provide operational leadership and continuity across the function, enabling the US Affiliate & Commercial Leadership Team to remain focused on the highest‑impact priorities as Dyne builds and grows its US presence.

The Director will be responsible for business operations across the US Affiliate, including budget ownership and financial planning, vendor and contract management, operating rhythm and governance, and the execution of function‑wide initiatives. Acting as a connective hub across Commercial, Medical, Finance, Legal, HR, and other G&A partners, this leader will translate strategic priorities into well‑structured plans, drive execution, and ensure visibility into progress, risks, and resource needs.

The ideal candidate is highly organized, proactive, and comfortable operating in a fast‑paced, evolving environment. They bring strong judgment, executive presence, and the ability to influence without authority, paired with a hands‑on approach to getting work done.

This role is based in Waltham, MA.

Key Responsibilities

Strategic & Operational Partnership

• Serve as a trusted thought partner to the SVP, Head of US Affiliate, translating affiliate strategy and priorities into clear, actionable, and measurable operating plans as Dyne prepares for its first U.S. product launch. 
• Support the US Affiliate Leadership Team with structured problem solving, prioritization, and follow‑through across key initiatives.
• Anticipate organizational needs and proactively bring recommendations, options, and solutions to leadership.

Business Operations & Operating Rhythm

• Establish and manage the operating rhythm for the US Affiliate, including leadership meetings, business reviews, planning cycles, and governance forums.
• Drive clarity on goals, ownership, timelines, and success metrics across affiliate initiatives.
• Develop and maintain dashboards and tracking tools that provide transparency into performance, risks, dependencies, and decision points.

Budget, Financial Planning & Resource Management

• Support development and management of the US Affiliate budget in close partnership with Finance, including annual planning, forecasting, tracking, and variance management.
• Support headcount planning, resource allocation, and investment prioritization to ensure alignment with affiliate and enterprise objectives.
• Prepare budget materials, analyses, and recommendations for affiliate leadership and enterprise review forums.

Cross‑Functional & Enterprise Initiatives

• Lead and coordinate high‑priority, function‑wide and cross‑functional initiatives impacting the US Affiliate.
• Act as a central point of integration between the US Affiliate and partner functions to ensure alignment and execution.
• Track initiative progress, identify risks, and escalate issues with proposed solutions.

Leadership Enablement & Execution

• Drive coordination across HQ and field‑based roles spanning Commercial, Medical, and partner functions to maintain momentum and alignment on priority initiatives.
• Design and manage the US Affiliate “Cadence of the Business,” including Leadership Team meetings, offsites, business reviews, and short‑ and long‑term planning cycles.
• Serve as a leader for high‑priority initiatives that do not have a natural functional home (e.g., ways of working, launch KPI management, executive reporting).
• Support change management and organization‑wide communication for new processes, initiatives, and ways of working.

Vendor, Contract & External Partner Management

• Oversee vendor strategy and management for the US Affiliate, including agency partners, consultants, and other external service providers.
• Partner with Legal, Finance, and Procurement to manage contracts, statements of work, renewals, and compliance.
• Ensure vendors are delivering against scope, timelines, and value expectations.

Qualifications & Experience

• Bachelor’s degree required; advanced degree (MBA or equivalent) preferred.
• 10+ years of progressive experience in commercialization strategy, commercial operations, program management, or related roles within biotechnology or pharmaceuticals, or relevant experience from a biotech or life sciences consulting firm focused on commercialization or commercial planning.
• Experience supporting senior leaders and leadership teams in high‑growth or launch‑stage environments.
• Demonstrated experience with budget management, financial planning, and vendor/contract oversight.
• Strong cross‑functional leadership skills with the ability to influence without formal authority.
• Exceptional written and verbal communication skills; able to synthesize complexity into clear, executive‑ready thinking.
• Highly organized, detail‑oriented, and comfortable managing multiple priorities simultaneously.
• High integrity and discretion in handling sensitive and confidential information.

Role Summary: 

The Director, US Marketing Operations establishes and leads the tactical execution of marketing operations, with an immediate focus on launch readiness for Dyne’s lead assets in Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). As Dyne transitions into a fully integrated biotechnology company, this role plays a critical part in building the systems, processes, and operational infrastructure required to enable compliant, impactful, and efficient delivery of therapeutic education to US external stakeholders. 

The Director serves as a key partner across Marketing, Commercial Operations, Medical Affairs, Market Access, Patient Services, Regulatory, Legal, Compliance, and Information Technology, driving operational excellence and enabling speed to market in highly regulated and complex therapeutic landscapes 

Primary Responsibilities 

Commercial MLR Review Committee Leadership 

• Owns US Marketing Operations as a capability, setting standards, governance, and scalable operating models across the Commercial organization. 
• Chair and lead the Dyne Commercial Medical, Legal, and Regulatory review committee and manage the end-to-end content review and approval process for Commercial-led therapeutic education 
• Partner closely with Marketing, Medical, Legal, and Regulatory teams to foster a collaborative, solution-oriented review culture 
• Ensure timely, compliant review of HCP, payer, and patient-facing materials and optimize systems supporting content workflows such as Veeva Vault PromoMats 
• Partner and collaborate with Regulatory, Legal, and Compliance to maintain policies, procedures, and governance aligned with evolving regulatory standards 

HCP and Consumer Engagement 

• Design, develop, and implement a fit-for-purpose HCP and consumer peer-to-peer engagement model that meets the unique educational needs of rare disease launches in DMD and DM1 
• Oversee HCP and consumer engagement operations across the Commercial organization, including nomination, contracting, onboarding, training, logistics, and relationship management 
• Ensure compliance with all applicable industry regulations and internal policies, including fair market value requirements and Sunshine reporting 

Marketing Excellence and Performance 

• Serve as a strategic partner to Dyne Brand Teams, aligning Marketing Operations capabilities to commercial objectives to enhance executional effectiveness 
• Drive continuous improvement across marketing operations processes to support agility, scalability, and compliance 
• Oversee print fulfillment operations and manage promotional asset lifecycle planning 
• Partner with Commercial Operations, Information Technology, and Analytics teams to enable systems that track performance and integrate insights into campaign design and optimization 
• Ensure personalized and precise customer engagement through effective use of data, segmentation, and targeting strategies 

Congress and Meeting Management 

• Lead planning and drive the execution of US HCP and consumer-facing congresses, conventions, and field-sponsored events to maximize Dyne’s presence and engagement impact 
• Partner closely with Marketing, field-facing teams, and Medical Affairs to coordinate KOL engagement strategies at congresses, ensuring operational excellence, brand alignment, and compliance 

Qualifications 

• Bachelor’s degree required; advanced degree such as MBA or MPH preferred 
• 10+ years of experience in the pharmaceutical or biotechnology industry, with experience supporting rare disease or accelerated approval launches preferred 
• Experience leading promotional review processes in regulated environments  
• Demonstrated ability to thrive in fast-paced environments with strong prioritization and problem-solving skills 
• Proactive, adaptable, and solution oriented, with a track record of delivering results under tight timelines 
• Deep understanding of US regulatory requirements and compliance standards governing promotional activity 
• Excellent communication, interpersonal, and stakeholder management skills 
• Strong business acumen with the ability to translate strategic objectives into operating execution 
• Experience with commercial systems and platforms such as Veeva Vault PromoMats highly preferred 
• Experience operating effectively in a small, rapidly growing biotech environment with comfort navigating ambiguity 

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Role Summary:

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements. 

This role is based in Waltham, MA.  

Primary Responsibilities Include:

• Inform and contribute to audit planning and strategy 
• Perform and/or coordinate clinical site and vendor audits 
• Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs 
• Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends 
• Support inspection readiness activities and co-host regulatory inspections 
• Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements 
• Conduct and/or manage the qualification and oversight of service providers 
• Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness 
• Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity 
• Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings 
• Support investigational new drug (IND) applications and related correspondence with global regulatory authorities

Education and Skills Requirements:

• Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred 
• Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience) 
• Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements 
• Broad clinical development experience across all phases (Phase I through BLA/NDA) 
• Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages 
• Proven experience developing and implementing risk-based clinical quality assurance programs 
• Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings 
• Skilled at effectively communicating quality events and outcomes to internal stakeholders 
• Excellent interpersonal, verbal, and written communication skills 
• Working knowledge of multiple therapeutic areas is a plus 
• Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines 
• Flexible and creative problem solver with a proactive mindset 
• Highly collaborative team player who fosters open communication and cross-functional cooperation 
• Willingness to travel up to 20% based on business needs 

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Role Summary:

The Senior Director, Portfolio Reporting & Analytics is a strategic enterprise leader responsible for designing, building, and scaling a state-of-the-art reporting, analytics, and insights capability across our clinical development portfolio. This role establishes a single source of truth for study, program, and portfolio performance; delivers trusted time, cost, and quality insights; and enables confident, data-driven decisions by study teams, functional leaders, Governance, Dyne’s Executive Committee and Board. The leader will partner closely with R&D, Clinical Operations, Biometrics, Commercial, Finance, HR/Workforce Planning, and IT/Digital to implement a modern operational data infrastructure and advanced analytics—spanning descriptive to prescriptive (AI/ML)—that improves predictability, optimizes resources, and accelerates medicines to patients.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Enterprise Data & Insights Strategy

• Design, define, and advance a next-generation clinical and portfolio insights platform that delivers trusted, real-time reporting and analytics across studies, programs, and the portfolio—enabling monitoring of time, cost, and quality and supporting decision-making from study and program teams to the Executive Committee and Board
• Establish and govern one “source of truth” by integrating internal and external operational data (e.g., CROs and vendor feeds, benchmarking sources) into a harmonized model with robust data quality, lineage, and access controls

Data Foundation & Technology Enablement

• In close partnership with IT/Digital, architect a centralized operational data infrastructure (e.g., data lake/warehouse, semantic layer, data products) that powers consistent analytics and self-service business intelligence
• Integrate operational planning data (study/program plans, budgets, baselines) with actuals to enable accurate planned vs. actual comparisons for timelines and costs
• Implement scalable operational data governance (metadata, master data, standards) aligned with R&D operating models and GxP expectations

Analytics, KPIs & Methodologies

• Develop streamlined, standard analytical frameworks and methodologies (definitions, metric specifications, visualization standards) to drive consistency and comparability across the organization
• Define and operationalize clinical study, program, and portfolio KPIs (e.g., cycle times, site activation and enrollment velocity, budget adherence, deviation/quality indicators, vendor performance, milestone attainment) and performance analytics
• Lead the creation of advanced analytics and simulation capabilities to predict and optimize development timelines, costs, and risks (e.g., slippage forecasting, patient enrollment trajectories, budget risks, operational risks), including evaluation of operational implications

AI-Enabled Prescriptive Insights

• Design and deploy prescriptive analytics powered by AI/ML that anticipate study, program, and portfolio-level challenges and provide actionable recommendations (e.g., mitigation strategies, scenario trade-offs, risk flags, next-best actions)
• Enable portfolio-wide scenario modeling and resource planning, supporting governance decision-making (e.g., start/stop/sequence, trade-offs, capacity constraints and resource supply)

Country/Site Intelligence & Study Delivery

• Develop predictive country and site selection analytics to optimize trial delivery (start-up speed, enrollment yield, data quality, cost) and inform feasibility and country footprint decisions
• Establish a study-level insights platform that leverages structured operational data to provide site- and PI-level insights (enrollment health, quality, cost, competitive trial density) to study teams and vendor partners

Resource Management & Capacity Planning

• Design and institutionalize an integrated resource management capability that dynamically analyzes resource demand vs. actuals across the portfolio; predicts AI-enabled resource demand; and highlights capacity bottlenecks for scarce skills/roles in close partnership with HR and functional leaders

Operating Model, Change & Adoption

• Drive change management and adoption of new analytics capabilities, ensuring insights are embedded in business rhythms (governance reviews, QBRs, portfolio prioritization, study health checks)

Education and Skills Requirements: 

• Bachelor’s degree in quantitative or life sciences field (e.g., Statistics, Data Science, Engineering, Operations Research, Epidemiology, Pharmacy, Biology).
  Preferred: Master’s or PhD in Data Science, Biostatistics, Operations Research, or related discipline; MBA a plus
• 15+ years of increasing responsibility in biopharma/biotech R&D with a focus on clinical operations analytics, portfolio management, or development operations, including 5+ years leading multi-disciplinary teams
• Proven track record building enterprise data & analytics platforms and single source of truth solutions for R&D portfolios, integrating internal and external/vendor data (e.g., CRO feeds, benchmarks)
• Demonstrated expertise with portfolio, program, and study KPIs, operational planning and plan vs. actual analysis, and scenario modeling for timelines, costs, risks, and resources
• Hands-on experience with advanced analytics/ML (forecasting, simulation, optimization) and turning algorithms into operational tools that drive business decisions
• Strong understanding of the clinical development lifecycle, including feasibility, site activation, enrollment, data management, monitoring, and close-out; familiarity with GCP/GxP, data privacy, and validation expectations for decision-support tools
• Executive presence with the ability to influence senior stakeholders (Governance/EC), translate complex analytics into clear narratives, and drive enterprise alignment
• Collaborative corporate leader who partners effectively with other senior leaders to advance the company’s mission and portfolio
• Exceptional ability to influence without direct authority across all organizational levels, including senior functional leaders
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly to diverse audiences (written, verbal and presentation)
• Ability to interpret and communicate complex data to diverse audiences
• As a plus:
  • experience with site/country selection analytics, enrollment prediction, and vendor performance analytics
  • Familiarity with R&D systems (e.g., CTMS, EDC, eTMF, RTSM, safety, eCOA), portfolio/financial planning (e.g., enterprise planning tools), and HR capacity planning
  • Background in data governance (metadata, MDM), data product management, and adoption at scale
• Excellent team player
• Strong decision maker
• Ability to work in a matrix environment
• Ability to work independently as a hands-on manager, proactively contribute as a resource when necessary
• Flexibility to adapt and meet the changing/growing needs of our customers
• High level of integrity, compliance, ethics, and transparency
• Positive team member who embodies Dyne’s Core Values
• Excitement about Dyne’s vision and mission

Role Summary:

The Senior Manager, U.S. Medical Affairs Operations plays a critical role in enabling the success of the U.S. Medical Affairs organization as Dyne prepares for commercial launch and post‑launch execution. This role serves as an operational partner to the U.S. field medical teams (MSLs and MVLs) and U.S. Medical Directors, ensuring operational excellence, compliant processes, and seamless coordination across Medical initiatives. The person in this role brings strong project management skills, experience supporting field medical or medical affairs teams, and the ability to operate in a fast‑paced, high‑growth environment. 

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

Primary Responsibilities Include:

Field Medical Operations 

• Serve as the primary operational partner to the U.S. Field Medical team, ensuring effective planning, execution, and tracking of field medical activities.
• Manage onboarding, offboarding, and ongoing enablement tools for field teams (e.g., systems access, training coordination, field resources).
• Lead the coordination, maintenance, and operational execution of the U.S. Medical training curriculum.
• Oversee field medical platforms and systems (e.g., Veeva Systems, insights platforms, territory alignment tools).
• Partner with Field Medical leadership to support monthly dashboards, KPIs, activity metrics, and performance reporting.

 Launch & Post Launch Readiness 

• Provide operational leadership across U.S. Medical launch planning, including timelines, cross-functional coordination, resourcing, and workstream tracking.
• Support Medical Directors and Field Teams with execution of key launch deliverables (e.g., medical education materials, advisory boards, congress planning, scientific exchange tools). 

 General Medical Affairs Operations Support 

• Drive process development and continuous improvement across U.S. Medical Affairs, including SOPs, workflows, and training documentation.
• Maintain alignment with Medical Affairs leadership on budget management, forecasting, and expense tracking for U.S. Medical activities.
• Manage contracting processes for the U.S. Medical Affairs team, including Fair Market Value (FMV) assessments and coordination with relevant internal partners.
• Support development and execution of advisory boards, scientific and payor engagements, and other Medical initiatives.
• Support coordination of U.S. Medical leadership meetings, priorities, and strategic planning sessions.
• Serve as a key liaison between U.S. Medical Affairs and cross-functional groups including Medical, Commercial, Clinical Development, Regulatory, Compliance, Legal, and IT. 

 Systems, Tools & Compliance 

• Oversee operational governance of Medical Affairs systems, including Veeva CRM, insights management, content workflows, and field enablement tools.
• Ensure compliant processes consistent with medical and promotional review guidelines, industry regulations, and internal SOPs.
• Support generation of reports, dashboards, and data insights to drive operational decision making. 

 Education and Skills Requirements:

• Bachelor’s degree in life science or related discipline is required.
• 5+ years of experience in the pharmaceutical or biotechnology industry, with experience supporting rare disease or accelerated approval launches preferred. 
• Strong organizational and project management skills, with the ability to drive timelines, meet firm deadlines, adapt quickly to changing priorities, and maintain attention to detail. Effective communication and interpersonal skills, with a proven ability to lead cross-functional initiatives and manage external partnerships.
• Experience with medical systems such as Veeva Systems, insights platforms and Fair Market Value (FMV) tools.
• Experience in data analysis and performance tracking.
• Knowledge of compliance, regulatory, and legal frameworks in medical affairs operations.
• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment.
• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations.
• Exceptional written and verbal communication skills.
• Demonstrated ability to influence cross-functional stakeholders without direct authority.
• Highly collaborative team player with a strong cross-functional mindset.
• Meticulous attention to detail with a commitment to quality and compliance.
• Positive, proactive, and resilient team member who embodies Dyne’s Core Values. 
• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases. 

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Role Summary:

The Executive Director, Regulatory Affairs Advertising & Promotion leads regulatory strategy and compliance for advertising and promotional activities across all external communications. This role serves as the subject matter expert, partnering with the launch team, commercial, medical affairs, R&D, corporate communications, legal, and leadership to ensure messaging aligns with FDA regulations and company objectives. The person in this role provides strategic guidance on complex promotional claims, anticipates market and regulatory factors, and drives innovative, compliant solutions. This role chairs the regulatory review for the Promotion Review Committee (PRC) and for the Medical Review Committee (MRC), balancing legal requirements with business goals while mitigating risk across promotional campaigns and corporate communications. 

This role can be located in Waltham or remotely with travel to our office per business needs.

Primary Responsibilities Include: 

• Serves as the subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives 
• Proactively identifies and evaluates fundamental issues, providing strategy and direction, anticipating factors that could influence strategies and company position in the market 
• Leads the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance 
• Serves as lead Regulatory Advertising & Promotion expert on MRC 
• Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution 
• Proposes creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk 
• Supports Commercial launch teams, participating in strategy discussions and extended team meetings to provide regulatory guidance and perspective on marketing strategies and promotion objectives and tactics 
• Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives 
• Leads the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission, where applicable, of external communications content 
• Acts as the recognized authority on regulatory advertising and promotion matters. Able to work independently and deal with division or corporate functions, or with external agencies. 
• Serves as primary Regulatory Advertising & Promotion contact for Regulatory Agencies 
• Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion. 
• Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry and Communicates significant changes in FDA perspective to relevant stakeholders. 
• Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review 

Education and Skills Requirements: 

• BS degree in scientific, clinical or related area required. Advanced degree highly desirable. 
• 12+ years pharmaceutical/biotech industry experience with a minimum of 10 years of direct experience as primary Regulatory reviewer of advertising and promotional materials is required 
• In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising & promotion expertise 
• Successful launch experience, preferably including global product launches 
• Works comfortably with abstract ideas or situations across functional areas of the business 
• Strong track record of implementing successful business strategies for branded and unbranded promotional campaigns 
• Ability to see impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities. 
• Strong interpersonal skills and proven negotiator with demonstrated ability to use constructive debate to identify and move others towards compliant promotional outcomes 
• Ability to communicate and influence without authority at all levels of the organization and externally 
• Well organized with exceptional communication skills, strong influencing skills, strong technical writing and documentation skills, as well as strong analytical and problem-solving skills 
• Thinks innovatively and creatively, identifying the risks surrounding promotional claims and campaigns  
• Proficient in computer applications and configurations including Microsoft Office Suite or related software, Veeva PromoMats and Veeva MedComms systems 
• Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch 
• Positive team member who embodies the Dyne Core Values 
• Excitement about Dyne’s vision and mission  

Role Summary:

The position will support and oversee analytical method development, method transfer and qualification, and overall management of CMC activities related to internal and external analytical testing and stability of antibody drug conjugates and intermediates. The Principal Scientist will lead analytical development for several preclinical programs, and direct method qualification for use in GMP production of clinical materials (Phase 1-3) with guidance from analytical leadership. This includes identification, selection, and setup of a central testing lab (CTL), and coordinating external activities related to analytical method development at the CTL and at various manufacturing organizations (CDMOs). This role works closely with key stakeholders within Technical Operations as well as across the company including Platform Research, Regulatory, and Project Management.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Oversight of all analytical aspects for bioconjugate drug substance and drug product as well as support for PMO and ASO oligonucleotides and small molecule intermediates including analytical method development, product quality characterization, technology and method transfer, analytical method qualification, in-process and release testing, and stability programs.
• Assist with developing the analytical strategy for complex biologics/bioconjugates guided by ICH frameworks.
• Identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing.
• Work with partner organizations and internal quality as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, OOS/OOT investigations, and CAPAs are initiated, addressed, and closed within target timeframes.
• Develop, review and approve method transfer/validation protocols and validation approaches.
• Author and review change controls, risk assessments and product specifications.
• Manage external CMOs and CTLs for the transfer and validation of analytical methods, product characterization testing and product release/stability testing.
• Advise and plan extended characterization of intermediates and drug substance to expand product understanding and impurity characterization.
• Support establishment of critical quality attributes, specifications, and overall control strategy.
• Partner with QA to provide oversight of cGMP-related activities and documents (change controls, deviations, CAPAs, procedures, batch release support, stability protocols and programs etc.)
• Support Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate.
• Support the development of regulatory CMC documentation including INDs, IMPDs and BLA as well as RTQs.
• Support internal analytical wet lab work as needed and the development and expansion of the internal AD/CMC lab.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline.
• Minimum of 8 years of experience in Analytical Chemistry preferably in a clinical-stage biotechnology company.
• Knowledge and hands-on experience with a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.
• Strong experience with bioconjugates/ADCs a plus.
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

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Role Summary:

The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end to end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high quality clinical execution, and operate efficiently at scale. This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance 
 
Primary Responsibilities Include: 

TMF Strategy & Leadership: 

• Define and own the company’s TMF strategy, including innovation opportunities and continuous improvement initiatives 
• Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals 
• Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends 
• Represent TMF leadership in cross functional forums, governance committees, and senior level operational discussions 

Governance & Process Ownership: 

• Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards 
• Oversee TMF lifecycle management—from planning and setup through closeout and archival 
• Define TMF roles, responsibilities, and RACI structures across internal teams and vendors 
• Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues 
• Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners  

TMF Oversight & Compliance: 

• Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs) 
• Ensure TMFs across the portfolio remain inspection ready  
• Lead TMF related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate  
• Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities to implement proactively 

Vendor & Technology Management: 

• Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements 
• Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations 
• Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF 
• Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices  

Cross Functional Partnership & Support: 

• Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations 
• Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements 
• Advise leadership on TMF health and organizational readiness for key regulatory events 

Education and Skills Requirements: 

• Bachelor’s degree in life sciences or related field; advanced degree preferred 
• 8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise 
• Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations 
• Proven experience developing TMF strategy, governance frameworks, or enterprise level processes 
• Ability to lead cross-functionally without authority Demonstrated leadership in managing TMF operations or oversight at a portfolio level 
• Experience working with eTMF systems and CRO/vendor oversight 
• Excellent communication, influencing, and stakeholder management skills 

Role Summary: 

We are seeking a Director, Global HEOR, to lead the strategy and execution of how we define, substantiate, and communicate the value of one or more medicines approaching commercialization. This role is responsible for ensuring that, from clinical development through real-world evidence generation and payer engagement, we are making the strongest and best-supported arguments to secure access to our medicines. Accordingly, the Director, Global HEOR, helps shape development plans, evidence strategies, and value narratives so that they align with how payers and health technology assessment (HTA) bodies make decisions, balancing analytical rigor with a clear focus on what is relevant for decision-making.

This is a highly cross-functional, hands-on role for someone who combines deep analytical thinking with sound judgment, intellectual curiosity with pragmatism, and a strong orientation toward results. The role directly influences how our medicines are developed, positioned, and ultimately accessed by patients worldwide. Success in this role requires continually asking not just “Is this analysis methodologically defensible?” but “Does this help us make a better case for access, and if not, what would?”

This role is based in Waltham, MA.

Primary Responsibilities Include:

• Informing development strategies from HEOR / market access perspective
• Represent the HEOR and market access perspective in internal clinical development and regulatory forums
• Provide critical input into clinical development plans, including protocol design, endpoint selection, and other aspects of clinical trial evidence generation, to ensure alignment with future payer and HTA expectations
• Communication of value to payers and HTA bodies
• Lead development of AMCP dossiers for US payers
• Lead development of cost-effectiveness models for NICE and other HTA bodies requiring formal cost-effectiveness analyses
• Serve as a core team member for HTA submissions outside the US, with responsibility for shaping and stress-testing value narratives included in pricing and reimbursement dossiers and interpreting and recommending evidence to support such narratives, in a way that optimizes both credibility and relevance for payer decision-making
• Make substantial contributions to other payer communication materials (e.g., Medical Value Liaison slide decks) and launch readiness activities as needed
• Leading real-world evidence strategy and execution of real-world analyses
• Lead planning of real-world evidence generation activities to address evidence gaps as needed for informing decision-making by payers, HTA bodies, and clinicians
• Oversee execution of real-world data analyses, ensuring analytical rigor and fitness for purpose
• Interpret and translate results from real-world analyses into peer-reviewed publications and other external communications intended to meaningfully inform clinical practice and payer/HTA decision-making

Education and Skills Requirements:

• Bachelor’s degree or equivalent experience in a relevant field such as economics, public health, epidemiology, biostatistics, health policy, life sciences, or a related discipline.
• Advanced degrees (Master’s, PhD, PharmD, MD) are welcome but not required.
• 10+ years of progressive experience in HEOR, health analytics, value demonstration, market access, or a closely related quantitative or scientific field.
• Demonstrated success leading complex evidence‑generation, modeling, or analytical programs within biopharma, healthcare consulting, payer organizations, or academic research environments.
• Experience influencing senior leaders and driving strategic decisions through evidence and structured analysis.
• We are looking for candidates who demonstrate the following skills and qualities:
  • Analytical ability: Strong reasoning and structured problem‑solving capabilities, with curiosity, persistence, and creativity to tackle complex, open‑ended problems.
  • Sophisticated understanding of evidence: Clear judgment about what different analytical methodologies can and cannot tell you, and what makes an analysis more or less robust.
  • Understanding of value frameworks: Familiarity with decision‑making frameworks that inform how medicines are valued, priced, and reimbursed.
  • Strong mathematical intuition: Deep understanding of how numbers work, how models behave, and how assumptions propagate through analyses.
  • Critical evaluation of scientific literature: Ability to read, interpret, and rigorously critique medical, scientific, and health economics publications.
  • Biological and clinical literacy: Sufficient grounding in biology and clinical science to engage effectively with development teams and external clinical experts.
  • Results orientation: Focus on organizational priorities—balancing rigor with pragmatism and avoiding analysis for analysis’ sake.
  • Bias toward solutions and progress: Mindset oriented toward finding solutions, offering alternatives, and maintaining momentum.

Role Summary: 

The Senior Director, Pricing and Reimbursement is an experienced and strategic leader who is responsible for developing and executing global pricing and market access strategies to ensure optimal market positioning, pricing, and patient access solutions for our innovative products.

This strategic leader establishes the overarching pricing and reimbursement strategy in alignment with the market access and commercialization strategy and has a proven track record of leading and coordinating strategic activities aimed at building, shaping, and accelerating access, securing reimbursement across global markets. They create effective and productive partnership with cross-functional partners to influence strategic clinical development and commercialization decisions, as well as driving and executing pricing and market access strategies to support the differential value of Dyne assets for payer and HTA stakeholders across all stages of the product lifecycle.

The person in this role has strong leadership skills, a broad understanding and deep experience of global pharmaceutical markets (US & global markets) and a proven track record of bringing products to market successfully.

This role is based in Waltham, MA.

Primary Responsibilities Include: 

• Lead the development and implementation of global pricing and market access strategies for our late-stage and early pipeline products, including value proposition and messaging, payer engagement, early access programs, pricing strategies, market access plans, launch sequence optimization, pricing narratives, pricing policy and governance.
• Collaborate cross-functionally with HEOR, R&D, Program Teams, Commercial, Medical Affairs, and other teams to integrate pricing, reimbursement and market access considerations throughout product lifecycles
• Develop and communicate compelling value story narratives and messaging for payers, health technology assessment (HTA) bodies, and other stakeholders
• Develop market access and pricing strategies to optimize product value and patient access globally, including innovative non-traditional market access solutions and contracting approaches to meet evolving payer needs
• Ensure integration of market access and pricing strategies into clinical development plans, brand plans, launch strategies, and launch sequencing decisions
• Provide pricing guidance and assumptions for strategic planning, annual forecasting, and brand budget processes
• Develop resources and materials to be leveraged by the local teams in the engagement with market access stakeholders
• Collect actionable insights through market research, expert input forums, advisory boards, early payer advice, and engagement with external stakeholders
• Represent the company externally on pricing and market access topics with payers, policymakers, and industry groups
• Build, lead and coach a high-performing global pricing and reimbursement team
• Represent Dyne pricing and market access on key senior-level governance forums, working groups, and teams
• Understand and abide by global compliance regulations

Education and Skills Requirements: 

• Advanced degree (PhD, PharmD, MD, or MBA) in a relevant field)
• 12+ years of experience in pharmaceutical/biotech industry with significant leadership experience in global pricing, reimbursement and market access roles
• 5+ years’ experience in people management, with experience building and leading high-performing global teams
• Deep understanding of global healthcare systems, pricing dynamics, and market access requirements
• Proven track record developing successful global pricing and market access strategies for specialty and rare disease products
• Excellent communication and presentation skills, with ability to influence senior leadership
• Experience building and leading high-performing global teams
• Strategic mindset with ability to navigate complex stakeholder environments
• Ability to travel globally on a regular basis

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Role Summary:

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.  This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable.  This position partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams.   

This role is based in Waltham, MA 

Primary Responsibilities Include:

• Lead CMC Regulatory execution for specific programs at all stages of development  
• Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements 
• Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership 
• Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes 
• Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activities 
• Leverage both technical and regulatory knowledge to proactively mitigate risks 
• Serves as the Regulatory Affairs CMC representative in functional and team meetings 
• Act as point of contact to cross-functional teams on global Regulatory CMC project/program issues 
• Execute regulatory policies and operational processes to deliver high quality regulatory submissions 

Education and Skills Requirements:

• Minimum of a bachelor’s degree in life science or related discipline is required 
• Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company 
• Experience in Rare Disease preferred  
• Experience leading and developing CMC sections of Biologics marketing applications preferred 
• Solid understanding of FDA regulatory guidance, ICH guidelines 
• Strong experience with CTD format and content of regulatory filings   
• Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends 
• Knowledge of EU and international regulations related to clinical and nonclinical, development a plus 
• Ability to work independently to manage multiple projects in a fast-paced environment 
• Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones 
• Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management 
• Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail 
• Recognized as a leader, team player, and possess a cross-functional collaborative skill set 
• Ability to influence without authority  
• Positive team member who embodies the Dyne Core Values 
• Excitement about Dyne’s vision and mission  

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Role Summary:

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance.  The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.  

This is an onsite role based in Waltham, MA.

 
Primary Responsibilities Include: 

• Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities. 
• Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines. 
• Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs. 
• QA support of Tech Transfer and Process Validation activities. 
• Disposition of GMP batches and interfacing with the Qualified Person (QP). 
• Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. 
• Manage CDMO performance within Quality Agreement expectations and GMP compliance.  
• Drive continuous improvement and inspection readiness.  
• Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally.  
• Adjudicate on compliance discussions and negotiate any required corrective actions. 
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence. 

Education and Skills Requirements: 

• Minimum of a BA/BS degree 
• Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company 
• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority 
• Experience implementing and utilizing various outsourcing and support models 
• Experience with disposition of product batches and interfacing with a Qualified Person (QP) 
• Excellent written and oral communication skills, including well-developed presentation skills 
• Excellent organizational skills and ability to manage multiple priorities 
• Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization 
• General business management knowledge to assess the impact of project decisions on financial and corporate objectives 
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 
• Embrace Dyne’s core values and culture 

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Role Summary:

The Director of Training leads the vision, strategy, and execution of Dyne’s training programs, ensuring all field-facing teams are equipped with the knowledge, skills, and capabilities needed to excel. This role oversees the development, integration, and continuous enhancement of training frameworks, curricula, digital learning assets, and capability-building initiatives that support both initial onboarding and ongoing professional development across all functions required for Account Management.

The Director provides strategic oversight of vendors and training partners to ensure consistency, quality, and alignment across the commercial field. Working cross-functionally with Commercial Leadership, Medical Leadership, Compliance, Marketing, HR, and Field Leadership, this role translates strategic business priorities into high-impact learning solutions that elevate field performance and drive commercial excellence.

This leader guides the development of modern learning systems and processes, identifying capability gaps through data, field insights, and performance metrics. The Director plays a key role in supporting product launches, enhancing field readiness, and strengthening leadership capabilities throughout the organization. Through innovative training strategies and disciplined execution, this role ensures Dyne’s field teams are prepared to deliver exceptional customer experiences and achieve business goals.

This role is located at our office in Waltham, MA.

Primary Responsibilities:

• Coordination of the new hire training and ongoing skills/knowledge training across all cross functional field-facing facing teams.
• Ensure that the training curriculum and on-boarding processes meet the current and emerging needs of the field-facing employees.
• Oversee the development, updating, and use of all training modules that are appropriate for field employees.
• Create training materials that enhance the learning process; including study guides, home study materials, assessments, frequently asked questions, competitive overviews, etc.
• Lead field employee training across all settings which include 1:1 meetings, conference calls, live classroom, etc.
• Gather and analyze data from direct field observations, focus groups, and other methods to identify potential training gaps and suggest areas for improvement that will enhance performance and achieve Dyne’s goals.
• Manage the training of field employees on cross functional business rules (ie. Veeva CRM, Concur, Patient Services data/CRM, etc.).
• Work closely with cross functional Leadership to ensure that the development of training initiatives is designed to strengthen the pull through of Dyne’s Field Leader capabilities and competencies.

Cross Functional Collaboration

• Support leadership in leading content development workstreams across field meetings from an objective, content, and agenda standpoint.  
• Work with the cross-functional teams to gather feedback on training needs and development of necessary meeting workshops to meet those needs.
• Work with account leadership to facilitate management-level “train-the-trainer” sessions.
• Assist field teams and account leadership with field coaching, recruiting, and interviewing as needed.

Systems and Employee On-going Personal Development

• Create and manage the Learning Management System (LMS), and all vendors related to field training and development resources.
• Work with corporate compliance and/or our compliance agency partner to ensure field employees are trained and up to date on policies and procedures that affect their respective functional areas.
• Other duties as assigned

Education, Experience, & Skills:

• Bachelor’s degree (science or business preferred) or equivalent combination of relevant education and applicable job experience may be considered. MBA preferred.
• A minimum of 12 years’ progressively responsible experience in pharmaceutical or medical sales and training, with a minimum of 6 years in a training or field leadership role.
• A focus on neuroscience and Rare Disease preferred.
• Requires prior pharmaceutical field experience, first-line pharmaceutical/biotech field management experience, and vendor and contract management.
• Experience with product launches and Account Management experience is highly desired.
• Demonstrated leadership and teaching/facilitation ability.
• Proven ability in creating effective training materials.
• Proven application of adult learning principles.
• The ability to successfully navigate challenging situations and conversations with diplomacy, respect and flexibility when required.
• Experience in launching a product in a rare disease
• Excellent interpersonal and communication skills.
• Ability to complete verbal and written evaluations of others.
• Organization, initiative, and self-motivation.
• Project and vendor management experience.
• Professionalism, integrity, and the ability to comply with strict policy, work in a highly regulated environment and maintain confidential information and data.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
• Ability to travel up to 30% overnight.

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Role Summary: 

The Associate Director, Commercial Insights and Analytics is responsible for driving the development and execution of market insights to support commercial preparation for Dyne’s first product launches in rare neuromuscular diseases. Key areas of focus include data analytics and reporting, forecasting, market research, and competitive intelligence.

This individual, who reports directly into the Senior Director, Insights and Analytics, also works closely with many other functions, including but not limited to, marketing, market access, and program teams to support insights generation that will drive brand strategy and execution.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Commercial Data Analytics and Reporting

• Build and maintain reporting systems using tools like Tableau, Power BI, etc.
• Partner with IT/Data teams to ensure data integrity and integration across platforms (CRM, claims, EMR, etc.)
• Standardize reporting templates for executive, field, and cross-functional use
• Support implementation of KPIs and performance dashboards across functions
• Educate internal stakeholders on data literacy and dashboard usage
• Stay current on industry trends and emerging tools to continuously elevate analytics capabilities
• Ensure compliance with data governance and privacy standards
• Manage vendor relationships for data acquisition and analytics platforms

Forecasting

• Develop forecasting models and scenario planning tools for product uptake, access, and revenue using best-in-class forecast modeling approaches.
• Actively evaluate current forecasting processes/methodologies for opportunities to enhance capabilities, with a focus on accuracy and agility
• Triangulate and pressure-test assumptions with various data sources (primary research, competitive intelligence, analogs, etc.) and clearly communicate assumptions to key stakeholders
• Support long-range planning and scenario modeling activities for internal assets (including lifecycle management)
• Leverage strong analytical capabilities and experience to create clear actionable insights and provide strategic recommendations
• Serve as a strategic business partner for commercial leads and cultivate strong relationships with key stakeholders and peers across Brand Teams, Market Access, Finance, Supply, Trade, and IT

Market Intelligence 

• Collaborate with commercial leads to develop, refine, and implement insights generation plans for decision support
• Lead competitive analysis to assess market dynamics, product positioning and to monitor emerging threats.
• Manage projects and relationships with market research and intelligence vendors, ensuring alignment with business needs and quality standards
• Present key insights and recommendations to senior leadership with clarity and strategic context

Education and Skills Requirements:

• Bachelor’s degree required; advanced degree (MBA, PhD, PharmD) preferred 
• 8+ years of experience in analytics, reporting, or commercial insights in biotech/pharma (either in-house or at vendor). Experience supporting new product launches and/or rare diseases preferred.
• Familiarity with regulatory requirements and industry standards related to market research and data analytics in the pharma/biotech sector
• Strong proficiency in analytical tools, models, software and data visualization platforms used to work with large and complex datasets(e.g., Tableau, Power BI)
• Exceptional communication and presentation skills with a track record of effectively conveying insights to diverse audiences of internal and external stakeholders
• Strong data storytelling skills with ability to distill complex information into concise and impactful visuals, messages, and presentations
• Ability to operate in a fast-paced, dynamic environment, managing multiple tasks and priorities simultaneously
• Knowledge of AI tools and digital technologies
• Comfortable manging and negotiating with external vendors
• Upholds the highest standards of professionalism, ethics, and integrity

Role Summary:

The Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution both internally and across global CDMOs. This role spans the full development lifecycle - from preclinical process and analytical development through GMP manufacture for IND-enabling studies.  The role will ensure the delivery of robust, scalable, and cost-effective manufacturing processes, serve as the primary technical lead for external CDMOs, driving aggressive timelines while delivering well-characterized products optimized for our proprietary bioconjugation platform.  As a core member of multiple CMC teams, the Associate Director of Oligonucleotide Development will steer the development of preclinical assets and define CMC strategies within a matrixed environment. The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. 

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

Technical Leadership & Strategy

• Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply.
• Define Analytical Strategy: Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both payloads and conjugated drug substances.
• Innovate & Improve: Proactively identify and implement emerging technologies and "continuous improvement" initiatives to enhance product quality and manufacturing efficiency.
• Cross-Functional Liaison: Act as the primary CMC representative to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment. Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

External Partner & Project Management

• CDMO Governance: Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines.
• Technology Transfer: Spearhead the seamless transfer of processes and analytical assays to external partners, ensuring technical success and data integrity.
• Issue Resolution: Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.

Regulatory & Quality Compliance

• Regulatory Authoring: Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content.
• GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.
• Knowledge Dissemination: Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. 
• Oligonucleotide Expertise: Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.
• CMC Lifecycle Mastery: Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing.
• External Management: Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.
• Regulatory Authority: Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).
• Analytical Depth: Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.
• Strategic Problem Solving: Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.
• Collaborative Influence: Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.
• Project Leadership: Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines.

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Role Summary:

The Senior Director, Scientific Communications Lead - DMD provides leadership for the planning, development, and execution of an integrated scientific communications strategy for Dyne’s Duchenne muscular dystrophy program. This role is responsible for defining long-term strategies that translate complex scientific, clinical, and real-world data into clear, accurate, and compliant communications for internal and external stakeholders, including healthcare professionals and payers. The ideal candidate brings deep expertise in strategic scientific communication planning and cross-functional leadership ensuring close partnership with other functions withing the Global Medical Affairs team, as well as with Clinical Development, Biostatistics, Research, HEOR, Commercial, and Corporate Communications to ensure cohesive planning and execution of Dyne’s scientific and medical education strategy. 

This role is based in Waltham, MA. 
 
Primary Responsibilities Include:  

• Develop and lead the global scientific communications strategy for DMD aligned with program and corporate objectives 

• Develop and ensure the execution of a long-term strategic publication plan, including integration of preclinical, clinical, and real-world evidence data into dissemination roadmaps and evidence-generation narratives, and maintain visibility into timelines, dependencies and risks to ensure on-time delivery 

• Assist in developing Dyne’s overall congress strategy and presence, including planning medical booth assets, symposia, and presentations 

• Plan and execute global medical communications initiatives (e.g., IME, roundtables) that support product strategy 

• Serve as strategic advisor to cross-functional teams on scientific messaging and data interpretation 

• Partner closely with Patient Advocacy and regional medical teams on the development of publications and educational materials for their respective audiences 

• Manage agency partners and external vendors to deliver high-quality outputs 

• Manage budgets and resources to support long-term planning and execution 

• Mentor junior members of the team 

Education and Skills Requirements: 

• Doctorate degree (MD, PhD, PharmD) with 12+ years of experience with a focus on rare diseases, neuromuscular experience, or related discipline 

• Analytical skills, 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 

• Experience in building strong and effective relationships with thought leaders 

• Experience in managing vendor partners 

• Excellent written and verbal communication skills 

• Launch experience preferred 

• Travel up to ~20% 

Role Summary:

The Principal Engineer, Technical Development serves as a technical engineering lead and driver for strategy, conception, optimization, and implementation of innovative manufacturing technologies within the Technical Development organization. This leader blends deep engineering expertise with cross-functional influence to implement innovative manufacturing systems for bioprocess and bioconjugation at clinical and commercial scales and accelerates time to market. The role is ideal for someone who thrives at the intersection of innovation, operations, and process development strategy.

This is a full-time position based in Waltham, MA with no option for remote work.

Primary Responsibilities:

Technical Leadership

• Design, optimize and implement engineering for manufacturing processes for new and existing products under current Good Manufacturing Practices (cGMP)
• Lead engineering technology selection, process modeling, equipment specification, and system integration and provide guidance and oversight of outsourced activities at CDMOs.
• Develop and validate process control strategies, including PAT, automation, and real time monitoring.
• Serve as the subject matter expert for engineering across manufacturing, operations, and R&D.

Strategic Impact

• Build and execute the long-term engineering roadmap for manufacturing capabilities across all relevant modalities (biologics, oligonucleotides, and bioconjugates).
• Identify opportunities to transition batch processes to innovative platforms, improving throughput and cost-of-goods, while preserving product quality.
• Partner with senior leadership to align manufacturing strategy with business goals and regulatory expectations.

Cross Functional Collaboration

• Work closely with Quality, Supply Chain, and Manufacturing Operations to ensure seamless technology transfer and scaleup.
• Guide technical teams through engineering design reviews, process risk assessments, and regulatory submissions, fostering a culture of innovation and technical excellence.

Operational Excellence

• Drive continuous improvement initiatives using Lean, Six Sigma, and advanced process analytics.
• Troubleshoot complex manufacturing challenges and implement robust, sustainable solutions.
• Ensure compliance with cGMP, safety standards, and global regulatory requirements.

Education, Experience, and Skills Requirements:

• Bachelor’s degree in chemical or similar engineering discipline with minimum of 7 years relevant experience; advanced degree MS or PhD preferred
• Proven track record designing, implementing, and scaling manufacturing systems
• Hands-on approach for operation of and troubleshooting manufacturing skids
• Development and implementation of PAT technologies
• Experience overseeing outsourced activities at CDMOs
• Expertise in process modeling, control systems, automation, and PAT.
• Experience in Biologics Downstream Purification Process Development and/or Bioconjugation Development preferred
• Familiar with the concepts of Scale-Down Model Qualification (SDMQ), Process Characterization, and defining Process Control Strategy (PCS)
• Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory frameworks (FDA, EMA, ICH) relevant to continuous manufacturing of biologics.
• Attention to detail, exceptional communication skills, and the ability to influence all levels of the organization.

Role Summary:

The Director of Imaging Biomarkers leads the development and execution of innovative imaging strategies across Dyne’s therapeutic programs. This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on enhancing the understanding of disease mechanisms, patient populations, evaluating therapeutic efficacy, and supporting clinical trial designs through innovative imaging approaches. This role is critical to linking early phase research to clinical development, providing essential insights that drive decision making. The person in this role leverages their expertise in various imaging modalities to develop novel biomarker applications that assess therapeutic efficacy, drive patient-centric trial designs, and facilitate regulatory approval processes. This role combines scientific depth with strategic vision, driving the discovery, validation, and application of advanced imaging modalities to enable precision medicine and accelerate drug development. The person in this role serves as a trusted expert and collaborative leader, fostering innovation and ensuring scientific rigor in both preclinical and clinical settings.  

This role is based in Waltham, MA.   

Primary Responsibilities Include: 

• Collaborate with cross-functional teams including clinical development, biostatistics, and regulatory affairs to ensure that imaging biomarkers are effectively integrated into clinical trial protocols 
• Enable the delivery of high-quality data supporting both internal decision making and external communications with stakeholders, including regulatory authorities  
• Define and execute the imaging biomarker strategy aligned with clinical and translational objectives 
• Serve as the subject matter expert for imaging biomarkers across pre-clinical and clinical programs 
• Lead the development, validation, and qualification of imaging biomarkers for disease characterization, patient stratification, and pharmacodynamic assessment 
• Partner with Clinical Development, Translational Biomarkers, Biostatistics, Data Management and Regulatory teams to integrate imaging biomarkers into Dyne clinical trials 
• Evaluate and implement cutting-edge imaging technologies (e.g., MRI, PET, CT, ultrasound, optical imaging) 
• Ensure compliance with regulatory standards for imaging biomarker development and qualification 
• Collaborate with external imaging CROs, academic institutions, and technology vendors to deploy imaging biomarkers into Dyne clinical trials 
• Oversee vendor selection and budget management for imaging-related activities 
• Manage imaging biomarker operations in clinical studies including protocol development, support site training, and data quality assurance 
• Foster a culture of innovation and scientific rigor 

Education and Skills Requirements: 

• Ph.D., M.D., or equivalent in Biomedical Engineering, Medical Physics, Radiology, or related scientific disciplines 
• 10+ years of experience in imaging biomarker development within pharma, biotech, or academic research 
• Blend of technical knowledge, scientific acumen, and strategic vision to foster collaborations with academic institutions, industry partners, and clinical experts  
• Deep scientific expertise in at least one major imaging modality (preferably MRI) and a strong understanding of image acquisition, processing, and analysis 
• Proven track record in applying imaging biomarkers in clinical trials and regulatory submissions 
• Expertise in quantitative imaging methodologies, image analysis software, and imaging data interpretation 
• Strong leadership and project management skills with ability to influence across functions 
• Excellent communication and presentation skills 

Preferred Experience: 

• Familiarity with AI/ML approaches for image analysis to improve efficiency, accuracy, and uncover complex patterns in imaging data 
• Understanding and implementation of digital biomarkers using wearables, sensors, or other digital health technologies 
• Knowledge of disease-specific imaging biomarkers (e.g., neurology, cardiology or neuromuscular) 

Role Summary:

The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for antibody oligonucleotide conjugates and intermediates. The Senior Scientist will represent CMC Process Sciences as a technical leader and provide guidance to internal process development staff and external vendors on oligonucleotide conjugate development and manufacturing activities from pre-clinical to GMP production for clinical evaluation (Phase 1-3). This includes active oversight of process establishment, process development, scale-down model verification, and process characterization. This person will also have direct oversight of CDMO technology transfer and process development operations.

This position works closely with key stakeholders including Platform Research, External Manufacturing, Regulatory Affairs, and Project Management to meet the needs of Dyne’s complex clinical supply chain, supporting our preclinical and clinical programs.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.
• Lead internal CMC Process Development activities via hands-on contribution in the laboratory.
• Work with CDMOs to manage external process development, optimization, and tech transfer of new programs in a stage appropriate manner to ensure key milestones and products are delivered on schedule.
• Partner with Research to support bioconjugation development activities and enhance the tech transfer process to external manufacturing partners.
• Represent bioconjugation Drug Substance process as a technical leader in internal cross-functional CMC teams.
• Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals.
• Select, qualify and manage external contract development and manufacturing organizations.
• Drive continuous improvement opportunities, adapt to and solve challenges and lead the timely resolution of issues.
• Evaluate and implement emerging technologies/applications to improve conjugation processes and optimize purification methods.
• Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies.
• Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 5+ years related experience working with bioconjugates including a deep understanding of conjugation chemistries, preparative chromatography, and TFF. 
• Experience in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company.
• Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense oligonucleotides, and siRNA is desired.
• Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis.
• Experience with oversight of external contract development and manufacturing (CDMO)
• Ability to problem solve emerging issues related to drug substance development.
• A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions.
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

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Role Summary:

The Senior Director, Program Management (PM) is a critical role within the cross-functional development team responsible for facilitating and driving execution across the wide spectrum of activities required for successful development of one or more molecules.  The PM partners closely with the Program Team Leader (PTL) and functional subject matter experts to ensure that plans are in place with appropriate detail and risk awareness to assure successful achievement of the goals of the development team.  The PM ensures integration of these detailed functional plans into a holistic, cohesive, and comprehensive program plan that achieves the strategic goals of the development program.  Given the inherent uncertainty associated with drug development in rare disorders, the PM maintains an agile mindset in order to effectively incorporate and react to emerging data and course correct as conditions dictate.  Working in close partnership with the PTL, the PM effectively frames and facilitates discussions with team members and external experts to elicit clear recommendations and decisions by fully engaging with team members to consider multiple options with a focus on impact on quality, time, and cost.  Their influence and engagement skills allow them to work with a highly motivated team and manage stakeholders at all levels of the company.  

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

Primary Responsibilities Include: 

• Lead the operations of one or more high performing cross-functional teams, with focus on both the “what”, such as priorities, goal achievement, and resources, and the “how” of maintaining a challenging, collaborative, and sustainable team environment 
• Partner with the PTL to identify short, medium, and long-term team priorities and propose path to address 
• Drive execution of the established and aligned Program vision and strategy for bringing a life-changing medicine to patients in need 
• Facilitate creation & maintenance of core program strategy documents including Target Product Profile (TPP), Clinical Development Plan, Regulatory Strategy, and Supply Strategy in collaboration with cross-functional representatives  
• Ensure that non-clinical, clinical, regulatory, and commercialization strategies and plans are aligned with the TPP and the overall Program Strategy 
• Inspire development of an efficient plan to achieve development and commercialization strategy, optimizing for quality, speed and cost 
• Ensure that program decisions are made in a timely, clear and efficient manner through interactions with the PTL, Program Team members, governance forums and other key stakeholders 
• Accountable for creation and maintenance of detailed cross-functional plans and effective visual summaries thereof to instill awareness, build accountability and facilitate achievement  
• Maintain clear and open communication with Program Team, Dyne Senior Leadership, and other stakeholders regarding program status, priorities, risks and needs, and facilitate appropriate strategic decision-making 
• Partner with Head of Program Management to evolve Program Management discipline to meet needs of a growing organization that intends to launch a portfolio of disease products 
• Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development 
• Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement 

Education and Skills Requirements: 

Proven and respected team member with:   

• Bachelor’s degree in science or related field; Advanced degree in a scientific discipline or MBA preferred 
• 15+ years of relevant experience in biotech/pharmaceutical industry in positions of increasing responsibility in drug development  
• Experience with late-stage clinical development and commercial stage programs required 
• Experience with neuromuscular diseases a plus 
• Exceptional communication skills (verbal, written, presentation) and ability to communicate with across a broad group of stakeholders and teams 
• Proficient with Microsoft Office 365 applications, Smartsheet and other PM management workspace collaboration tools 
• Expert at cross-functional teamwork and influencing without direct authority 
• Demonstrated experience in working with highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions 
• Passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening diseases  
• Adept at operating in cross-functional matrix teams, developing effective relationships based on mutual trust and effective communication and thrives in a fast-paced, patient-focused environment 
• Proven ability to establish and maintain credible and trust-based relationships  
• Outstanding sense of urgency and ability to help pace the team’s work in highly competitive environment 
• Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product 
• Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities 
• Ability to lead without authority through complex and ambitious projects in a cross-functional team environment and high-pressure circumstances 
• Comfortable in a results-driven, highly accountable environment where you can make a clear impact 
• Team player who listens effectively and invites response and discussion  
• A collaborator who communicates in an open, clear, complete, timely and consistent manner

Role Summary:

The Senior Manager, Scientific and Medical Education supports Dyne’s DMD program and contributes to the execution of publication and medical education activities for programs. This individual helps ensure that clinical and non-clinical data from Dyne’s studies are communicated in an accurate, timely, compliant, and compelling manner through high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations. 
 
Additionally, this role supports the creation of internal and external medical education materials such as field medical decks, medical booth collateral, symposia, and onboarding and training resources. The Senior Manager works cross-functionally within Global Medical Affairs and more broadly across the DMD program team to support aligned planning and execution of Dyne’s scientific and medical education activities. 
 
This role is based in Waltham, MA. 
 
Primary Responsibilities Include: 

• Support the development and execution of publication and medical education plans aligned with program and corporate strategies 
• Contribute to planning Dyne’s congress strategy and presence, including medical booth assets, symposia, and scientific presentations 
• Execute global medical communications initiatives (i.e. Symposia, roundtables) that support product strategy 
• Collaborate with Patient Advocacy to support development of patient-focused educational materials 
• Partner with Global and US Medical Affairs Leads to support alignment on program priorities and evidence gaps 
• Support the development Field Medical Affairs materials, both HCP and payor-focused 
• Maintain and update scientific communications platforms and materials  
• Maintain strong knowledge of relevant medical literature and data 

Education and Skills Requirements: 

• Doctorate degree (MD, PhD, PharmD) with 5+ years of relevant experience; rare disease or neuromuscular experience preferred 
• Strong analytical skills with ability to deliver against goals in collaborative, team-based environments 
• Ability to operate effectively within matrixed organizations and support cross-functional collaboration 
• Demonstrated ability to learn new disease areas or therapeutic modalities 
• Experience engaging with external experts and thought leaders 
• Experience working with external vendors or agencies 
• Excellent written and verbal communication skills 
• Proven ability to independently manage multiple complex projects in a fast-paced, dynamic environment 
• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations 
• Demonstrated ability to influence cross-functional stakeholders without direct authority 
• Highly collaborative team player with a strong cross-functional mindset 
• Meticulous attention to detail with a commitment to quality and compliance 
• Positive, proactive, and resilient team member who embodies Dyne’s Core Values  
• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases 
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 
• Embrace Dyne’s core values and culture 
• Excitement about the vision and mission of Dyne 
• Travel up to ~20% 

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Role Summary:

The US Medical Director of Medical Affairs leads Dyne’s medical strategy and execution within the United States, focusing on launch readiness, US-specific KOL engagement, congress planning and execution, and supports real-world evidence (RWE) initiatives. This role ensures alignment with global strategy while tailoring activities to US regulatory, payer, and healthcare landscapes. This role leads efforts to communicate and disseminate scientific and clinical information, engage with medical professionals in the field and contribute to the overall success of the company’s portfolio. The US Medical Director collaborates closely with Global Medical Affairs, US Commercial, Regulatory, Market Access, and Clinical teams to drive successful product introduction and lifecycle management in the US market.  

This role is located in our Waltham, MA office.

Primary Responsibilities Include: 

• Develop and execute US Medical Affairs strategy aligned with global objectives and US market needs 
• Act as point person for all US Medical Affairs launch readiness activities, including working closely with global medical director and scientific communications on development of scientific platform development, local congress planning, and local medical education programs 
• Support congress strategy execution in the US, including booth activities, symposia, and scientific presentations 
• Work closely and with the Head of the Medical Science Liaison (MSL) team on US KOL engagement strategy: identify, map, and build relationships with key US experts 
• Support insight collection and synthesis, and supporting the development of field material, working with the MSL team 
• Develop US Medical Affairs advisory board strategy and organize and execute advisory boards and expert panels 
• Work collaboratively with HCP and Patient Marketing as well as cross-functional stakeholders to integrate medical perspectives into brand strategy, ensuring alignment with scientific and commercial objectives 
• Partner with Clinical Development and Clinical Operations to support US trial site engagement and recruitment strategies 
• Working with the Global Medical Director, identify opportunities to generate real-world evidence (RWE) and phase IV data to address data gaps and support HCP and payer treatment decisions 
• Ensure compliance with US regulatory and legal requirements for all medical activities 
• Serve as subject matter expert on neuromuscular diseases and Dyne’s therapeutic platforms for US stakeholders 
• Support the review and approval of externally presented materials through the Medical Review committee and Promotional Review Committee  
• Act as a role model for integrity and compliance in all interactions 

Education and Skills Requirements: 

• Doctorate degree (MD, PhD, PharmD) with experience in rare diseases; neuromuscular experience preferred 
• Minimum 8 years of relevant experience in Medical Affairs within the US pharmaceutical/biotech industry 
• Proven ability to lead US launch readiness and medical strategy execution 
• Excellent communication and relationship-building skills with US KOLs and cross-functional teams 
• Ability to interpret and communicate complex scientific data to diverse audiences 
• Effective communication skills (written, verbal and presentation) 
• Must be willing to travel up to 30%, inclusive of overnight and occasional weekends to meet with customers, internal stakeholders and attend relevant conferences  
• Candidates must be authorized to work in the U.S. 
• Positive team member who embodies Dyne’s Core Values 
• Excitement about Dyne’s vision and mission  
• Experience managing direct reports  

Role Summary:

The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.
• Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.
• Build and enhance internal capabilities for formulation development in the laboratory.
• Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).
• Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
• Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
• Responsible for driving execution of the formulation development plan at CDMO (PO through delivery).
• Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. 
• Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
• Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.
• Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
• Strong experience and knowledge of cGMP manufacturing requirements.
• Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Experience managing complex schedules and priorities in a dynamic biotech environment.
• Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
• Collaborative work style to be part of a team to identify process gaps and constructively develop solutions.
• Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.

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Role Summary:

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide. 

The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs. This role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence. 

This role is based in Waltham, MA. 

Primary Responsibilities Include:

Strategic Leadership & Program Ownership 

• Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle management 
• Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectives 
• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply 

Regulatory Submissions & Health Authority Engagement 

• Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions and responses to Health Authority questions, including clinical and commercial manufacturing changes 
• Ensure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regions 
• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle 

Cross-Functional Leadership & Influence 

• Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risks 
• Represent Regulatory CMC in program, functional, and governance meetings, influencing decision-making without direct authority 
• Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones 

Operational Excellence & Knowledge Leadership 

• Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations 
• Leverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solving 
• Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning 
• Contribute to the advancement of Dyne’s regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organization 

Education and Skills Requirements:

• Bachelor’s degree in life sciences or a related scientific discipline required; advanced degree preferred 
• 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience in clinical-stage and/or commercial biotechnology companies 
• Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred 
• Experience in rare disease drug development preferred 
• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements 
• Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus 
• Deep understanding of the drug development process, accelerated regulatory pathways, and evolving global regulatory policy trends 
• Extensive experience with CTD structure, content, and global submission requirements 
• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment 
• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations 
• Exceptional written and verbal communication skills, including regulatory writing and executive-level communication 
• Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority 
• Highly collaborative leader and team player with a strong cross-functional mindset 
• Meticulous attention to detail with a commitment to quality and compliance 
• Positive, proactive, and resilient leader who embodies Dyne’s Core Values  
• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases 
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 
• Embrace Dyne’s core values and culture 

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Role Summary:

The Director of Compliance provides compliance guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies. These topics include HCP and patient engagement, disease‑state education, compliance with FDA regulations, health care fraud and abuse laws, Value & Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry. 

The Director of Compliance helps design and implement a global compliance program to ensure that Dyne complies with all applicable laws, regulations, and ethical codes where the company operates. The Director of Compliance works closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues. We seek a strategic, collaborative, solutions‑oriented leader with deep knowledge and experience. Prior rare‑disease and launch experience enables the Director of Compliance to help Dyne navigate the challenges of our first therapy launches. 

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

 
Primary Responsibilities Include: 

• Design and implement a comprehensive health care compliance program consistent with all laws, regulations, policies and industry standards. 
• Establish and refresh corporate policies, procedures and guidelines to ensure compliant operations across all Commercial, Medical and research activities. 
• Lead risk assessments to identify and prioritize compliance risks. 
• Develop and deliver risk-based compliance training for employees. 
• Develop and implement auditing & monitoring plans and related dashboards. 
• Lead confidential, thorough investigations into potential violations. 
• Establish Compliance as an approachable, knowledgeable, practical, helpful, solutions-oriented business partner. 
• Collaborate closely with the Franchise Counsel to align on consistent, actionable legal and compliance solutions. 
• Champion Dyne’s core values and culture of integrity. 
• Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies. 
• Perform additional duties as required. 

Education, Experience, and Skills Requirements: 

• Advanced degree in law, business administration or related field. 
• 10+ years of overall professional experience, including at least 7+ years of healthcare compliance experience, ideally within a global rare disease biotechnology company. 
• Deep expertise in U.S. health care laws, federal health care programs, and therapy launches. 
• Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws. 
• Experience supporting compliant patient engagement, HCP engagement, scientific exchange, and innovative patient support programs. 
• Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&A) on complex, time-sensitive matters. 
• Skilled at balancing strategic compliance guidance with practical business judgment in fast-paced, evolving environments. 
• Exceptional communication, analytical, and project management skills with attention to detail and execution excellence. 
• Collaborative leadership style and enterprise mindset that reinforces organizational culture and values. 
• Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach.