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Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

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Company Overview

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

Role Summary

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. The leader establishes the overarching pricing and reimbursement strategy in alignment with the market access and commercialization strategy, leading and coordinating strategic activities aimed at building, shaping, and accelerating access, securing reimbursement across global markets. They create effective and productive partnerships with cross‑functional teams to influence strategic clinical development and commercialization decisions, and drive and execute 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. This role is based in Waltham, MA.

Primary Responsibilities

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 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 of people management experience, with a track record of 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 the ability to influence senior leadership.
Strategic mindset with the ability to navigate complex stakeholder environments.
Ability to travel globally on a regular basis.

Pay Range

$241,000—$275,000 USD. The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

Equal Opportunity Statement

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

#J-18808-Ljbffr","

Company Overview

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically drive...","Senior Director, Pricing & Reimbursement",["B","1981953765"],"Work at Dyne Therapeutics","3 hours ago","/jobs/1981953765-senior-director-pricing-reimbursement","/jobs?keyword=Dyne+Therapeutics","/jobs?location=Waltham","/jobs?keyword=Senior+Director%2C+Pricing+%26+Reimbursement",{"_429":428,"_434":526,"_452":453,"_444":527,"_243":528,"_441":529,"_427":428,"_111":530,"_431":194,"_433":194,"_454":453,"_442":467,"_425":531,"_455":532,"_430":115,"_476":520,"_460":533,"_478":530,"_479":467,"_481":534,"_483":523,"_485":535},["D",1771476010000],"Dyne Tx","

Our commitment to people with neuromuscular diseases

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more and follow us on X, LinkedIn and Facebook.

Role Summary:

The Franchise Counsel serves as the lead counsel for clinical therapies and pharmaceutical brands. The Franchise Counsel provides legal guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies. These topics include advertising and promotion, 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. They partner closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues.

This role is based in Waltham, MA.

Primary Responsibilities:

Commercialization & Launch Readiness

Serve as lead counsel for Dyne’s therapeutic franchises, advising on commercial and medical strategies from development through launch.
Provide legal review and counsel for promotional and non-promotional materials, including sales and marketing collateral, scientific exchange, digital media, and disease-state education.
Advise on pricing, value & access strategies, contracting, trade and distribution matters, and patient access programs to ensure compliance with FDA, OIG, and industry standards.
Support launch, inspection, and filing readiness activities across cross‑functional teams.

Compliance & Risk Management

Advise on FDA regulations, federal and state fraud and abuse laws, and obligations under U.S. federal health care programs.
Support the development, implementation, and monitoring of Dyne’s compliance program.
Review and approve grants, sponsorships, and medical education programs in alignment with company policy and industry codes.
Oversee transparency reporting, data privacy (including GDPR and U.S. state laws), and other global health care compliance obligations.
Partner with Legal and Compliance colleagues to provide training and proactive risk assessments.

Business Partnership & Leadership

Act as the primary legal business partner to key functions including Commercial, Medical Affairs, Regulatory, and G&A.
Represent Legal on cross‑functional project and governance teams to support launch readiness and commercial objectives.
Collaborate with internal stakeholders and external partners to ensure compliant and effective business operations.
Help mature Dyne’s health care law capabilities and identify opportunities for process improvement and proactive legal risk management.
Support the Head of Legal in health care, compliance, and operational matters.

Education, Knowledge & Skill Requirements:

JD from an accredited law school; licensed to practice in at least one U.S. jurisdiction.
10+ years of health care law and compliance experience, ideally within a global biotechnology company and a top‑tier law firm.
Deep expertise in FDA regulations, U.S. health care laws, and federal health care programs; familiarity with ex‑U.S. frameworks (e.g., EFPIA, GDPR).
Strong understanding of PhRMA Code, Anti‑Kickback Statute, False Claims Act, data privacy, and transparency laws.
Demonstrated content review committee experience in the pharmaceutical industry.
Proven success advising cross‑functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&A) on complex, time‑sensitive matters.
Skilled at balancing strategic legal 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.

#LI-Onsite

MA Pay Range

$242,500 — $291,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job‑related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all‑inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

#J-18808-Ljbffr","

Our commitment to people with neuromuscular diseases

Dyne Therapeutics is focused on delivering functional improvement for people liv...","Senior Director, Franchise Counsel",["B","2625541240"],"Work at Dyne Tx","/jobs/2625541240-senior-director-franchise-counsel","/jobs?keyword=Dyne+Tx","/jobs?keyword=Senior+Director%2C+Franchise+Counsel",{"_429":428,"_434":537,"_452":453,"_444":527,"_243":538,"_441":539,"_427":428,"_111":540,"_431":194,"_433":194,"_454":453,"_442":467,"_425":541,"_455":532,"_430":115,"_476":520,"_460":542,"_478":540,"_479":467,"_481":534,"_483":523,"_485":543},["D",1771476172000],"

Our commitment to people with neuromuscular diseases

is our greatest strength

Senior Director, Drug Substance Manufacturing

Role Summary:

This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Responsible for bioconjugation activities including validation, characterization, scale‑up, clinical and commercial manufacturing.
Establish and manage contracts, supply agreements and CDMOs.
Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis.
Work closely with CMC Technical Development to support bioconjugation improvement activities and enhance the tech transfer process.
Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials.
Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions.
Support the development of regulatory CMC documentation and partner due diligence.
Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes.
Provide patents and creative ideas to provide protection or creation of new or better products or processes.

Education and Skill Requirements:

Bachelor’s degree in biology, biochemistry, chemistry, or a related scientific field required; advanced degree preferred.
Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs.
Proven expertise in bioconjugates, as well as strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements.
Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs.
Comprehensive experience with CMC regulatory submissions across all phases of development, ideally including post‑approval activities, global regulatory interactions, and negotiations with health authorities on CMC issues related to biologic APIs.
Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement.
Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels.
Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast‑paced, deadline‑driven environment, and consistently deliver on objectives.
Skilled in strategic thinking and problem‑solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions.
Excellent communication and negotiation skills, capable of building consensus and achieving win‑win outcomes across diverse stakeholders.
Self‑directed and adaptable, able to work independently with limited guidance in a complex and evolving environment.

#LI-Onsite

MA Pay Range

$217,280 — $266,750 USD

#J-18808-Ljbffr","

Our commitment to people with neuromuscular diseases

is our greatest strength

Senior Director, Drug Substance Manufacturing ...","Senior Director, Drug Substance Manufacturing",["B","2625565621"],"/jobs/2625565621-senior-director-drug-substance-manufacturing","/jobs?keyword=Senior+Director%2C+Drug+Substance+Manufacturing",{"_429":428,"_434":545,"_452":453,"_444":527,"_243":538,"_441":539,"_427":428,"_111":540,"_431":194,"_433":194,"_454":453,"_442":467,"_425":546,"_455":532,"_430":115,"_476":520,"_460":547,"_478":540,"_479":467,"_481":534,"_483":523,"_485":543},["D",1771476064000],["B","1980794205"],"/jobs/1980794205-senior-director-drug-substance-manufacturing",{"_429":428,"_434":549,"_452":453,"_444":550,"_243":551,"_441":552,"_427":428,"_111":540,"_431":194,"_433":194,"_454":453,"_442":467,"_425":553,"_455":554,"_430":115,"_476":520,"_460":555,"_478":540,"_479":467,"_481":556,"_483":523,"_485":543},["D",1771476173000],"BioSpace","

Senior Director, Drug Substance Manufacturing

Join to apply for the Senior Director, Drug Substance Manufacturing role at BioSpace

Company Overview

Role Summary

The Senior Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance). This role includes strategic vendor management for commercial drug substance production and coordination of external development and manufacturing activities with contract development and manufacturing organizations (CDMOs), contract testing laboratories (CTLs), and other key suppliers. This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts. This role is based in Waltham, MA.

Primary Responsibilities

Responsible for bioconjugation activities including validation, characterization, scale-up, clinical and commercial manufacturing.
Establish and manage contracts, supply agreements and CDMOs
Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
Work closely with CMC Technical Development to support bioconjugation improvement activities and enhance the tech transfer process
Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions
Support the development of regulatory CMC documentation and partner due diligence
Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes
Provide patents and creative ideas to provide protection or creation of new or better products or processes

Education & Skills Requirements

Bachelor’s degree in biology, biochemistry, chemistry, or a related scientific field required; advanced degree preferred.
Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs.
Proven expertise in bioconjugates, as well as strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements.
Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs.
Comprehensive experience with CMC regulatory submissions across all phases of development, ideally including post-approval activities, global regulatory interactions, and negotiations with health authorities on CMC issues related to biologic APIs.
Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement.
Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels.
Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast-paced, deadline-driven environment, and consistently deliver on objectives.
Skilled in strategic thinking and problem-solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions.
Excellent communication and negotiation skills, capable of building consensus and achieving win-win outcomes across diverse stakeholders.
Self-directed and adaptable, able to work independently with limited guidance in a complex and evolving environment.

Salary

Pay Range: $217,280 - $266,750 USD

#J-18808-Ljbffr","

Senior Director, Drug Substance Manufacturing

Join to apply for the Senior Director, Drug Substance Manufacturing role at BioSpace <...",["B","1981947409"],"Work at BioSpace","/jobs/1981947409-senior-director-drug-substance-manufacturing","/jobs?keyword=BioSpace","actionData","errors"]