Associate Director, Clinical Business Operations
Location: Waltham
Posted on: June 23, 2025
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Job Description:
Company Overview: Dyne Therapeutics is discovering and advancing
innovative life-transforming therapeutics for people living with
genetically driven neuromuscular diseases. Leveraging the
modularity of its FORCE™ platform, Dyne is developing targeted
therapeutics that deliver to muscle and the central nervous system
(CNS). Dyne has a broad pipeline for neuromuscular diseases,
including clinical programs for myotonic dystrophy type 1 (DM1) and
Duchenne muscular dystrophy (DMD) and preclinical programs for
facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Role Summary: The Associate Director, Clinical Business Operations
provides support for clinical vendor outsourcing and financial
oversight, tracking and forecasting for Dyne’s clinical trials.
This role is responsible for leading vendor identification and
selection efforts in support of Dyne’s Clinical trials ensuring
cross functional input and evaluation. Work to optimize and ensure
efficient spend within Clinical Operations. The Associate Director,
Clinical Business Operations works closely with cross functional
teams to ensure a fit-for-purpose outsourcing strategy and budget
management is achieved for each trial. This role will work closely
with other internal stakeholders including Finance, Legal and
Quality. This role is based in Waltham, MA without the possibility
of being a remote role. Primary Responsibilities Include: Lead and
manage the operational aspects of clinical business operations,
including overseeing clinical trial budgets, vendor selection and
relationship management Develop and implement strategic plans to
optimize clinical business operations and ensure the efficient and
cost-effective execution of clinical trials Collaborate with
cross-functional teams, including clinical development, regulatory
affairs, and finance, to align on trial execution plans and
milestones Manage relationships with external vendors, CROs, and
other partners to ensure high-quality deliverables, adherence to
timelines, and budget management Assist in the development and
management of clinical trial budgets, forecasting and expenses
Ensure compliance with regulatory requirements, GCP guidelines, and
company SOPs in all aspects of clinical business operations Provide
leadership and mentorship to team members, fostering a culture of
collaboration, continuous improvement, and excellence in clinical
business operations Provide support of the Request for Information
(RFI) and/or Proposal (RFP) process for Development programs and/or
clinical studies of various phases, complexity, and risk Manage
contract and financial negotiations with external service providers
for Development programs Partner with the Legal to ensure that the
appropriate templates and legal terms/conditions are applied
Maintain current knowledge of outsourcing industry trends and
provide ongoing support and training to key stakeholders on best
outsourcing practices Proactively identify and collaborate to
address opportunities for process or business improvements
including operational efficiencies Embrace and enable diversity of
perspectives to enhance the overall effectiveness of the team
Represent Clinical Operations and support other functions on
company-wide process improvements and initiatives Travel up to 25%
domestic and/or international Education and Skills Requirements:
Bachelor's degree; advanced degree (e.g., MBA, MPH) preferred At
least 8 years of experience working within a pharmaceutical/biotech
company, CRO, or similar organization Demonstrated leadership and
project management skills, with a track record of successfully
leading cross-functional teams and delivering results on time and
within budget Excellent communication and interpersonal skills,
with the ability to effectively collaborate and establish effective
business relationships with internal and external stakeholders at
all levels Experience in outsourcing management, vendor budget
negotiations, budget management, and vendor oversight Experience in
developing and implementing process improvements and operational
efficiencies in clinical business operations Experience as a
strategic partner providing effective and complex solutions and
systems to the organization Comprehensive understanding of clinical
trial operations regulatory requirements, with an understanding of
clinical trial operations Strong analytical, negotiating and
business communication skills. Ability to think strategically and
effectively communicate ideas Able to interact and influence
effectively with multi-functional teams at all levels of the
organization Self-motivated and able to prioritize and manage a
large volume of work in a dynamic, changing, growing start-up
culture LI-Onsite The statements contained herein reflect general
details as necessary to describe the principles functions for this
job, the level of knowledge and skill typically required, and the
scope of responsibility, but should not be considered an
all-inclusive listing of work requirements. Individuals may perform
other duties as assigned, including work in other functional areas
to cover absences or relief, to equalize peak work periods or
otherwise balance workload. This description is not intended to be
constructed as an exhaustive list of duties, responsibilities, or
requirements for the position. This position may change or assume
additional duties at any time. The employee may be requested to
perform different or additional duties as assigned. All Employees
are expected to adhere to all company policies and act as a role
model for company values. Dyne Therapeutics is an equal opportunity
employer and will not discriminate against any employee or
applicant on the basis of age, color, disability, gender, national
origin, race, religion, sexual orientation, veteran status, or any
classification protected by federal, state, or local law.
Keywords: , Leominster , Associate Director, Clinical Business Operations, Science, Research & Development , Waltham, Massachusetts
