Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Clinical Operations (Program) Lead is the clinical operations functional representative at the Program team, is responsible for developing and leading the strategy, planning, oversight, implementation and delivery of program and study level clinical operations deliverables as outlined in the clinical development plan (CDP). 

This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to the integrated development plan (IDP) and other key plans, such as the CDP, necessary to advance Dyne’s clinical programs. This individual develops and oversees implementation of program clinical operational strategy, ensuring appropriate considerations that include but are not limited to technical, vendor, quality site/ Investigator, geographical and patient centric considerations for the Program’s lifecycle. This individual may be responsible for one highly complex or multiple medium complexity clinical programs.  This individual may have one or more direct reports.  This individual will report directly into the Head of Clinical Operations.

This role is expected to require up to 20% travel, including international travel. 

Responsibilities Include but are not limited to:

  • Leads the development and ongoing refinement of Program level study timelines and scenarios in order to contribute to the CDP, IDP and other high-level strategic plans 
  • Provide rigorous, objective information (operational status and updates) to the Program team and, as necessary, Dyne senior leadership to help support strategic project decisions. 
  • Takes overall accountability for operational delivery of the clinical studies within a Program and provide appropriate oversight to ensure a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals.
  • Actively participates in Program team and other applicable sub-team meetings, collaborating and integrating with other functions within research and development, medical, and commercial in order to deliver on the CDP/IDP.
  • Responsible for the development and execution of a Program strategic clinical operations plan, taking into account the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule.  Proactively integrates stage-appropriate needs into the operational strategy. 
  • Oversees, mentors and works collaboratively with Clinical Study Lead(s) and other clinical operations and supportive roles within the Program (clinical trial coordinators, quality representative, vendor managers, etc.)
  • Overall accountability overseeing and driving CRO and other vendor relationships to ensure execution of clinical studies within the Program, within timelines, budget and with quality
  • Participates in departmental and cross functional risk assessment, technology development and process improvement initiatives, including SOP development, review and maintenance.
  • Participate/lead in site engagement programs to help build relationships with key opinion leaders, investigators, and clinical site staff to support the clinical study activities and delivery
  • Engage with patient advocacy groups to help build patient-focused clinical operations strategies, methods and tools for use in the clinical studies
  • Create and implement risk assessment and mitigation plans, performing regular reviews to continually assess for changes
  • Attend seminars, congresses, advocacy meetings, Investigator meetings, Program and sub-team meetings, educational conferences/training sessions
  • Provide management, training, oversight, coaching, mentoring and development to one or more direct reports

Education and Skills Requirements:

  • Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable.
  • Minimum of 10 years experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred)
  • Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning
  • Demonstration of effective team leadership of matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills
  • Experienced in identifying and leveraging relevant data and information to develop well-conceived and executable timelines
  • Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred. Experience with rare disease and/or pediatric trials also preferred
  • Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
  • Deep operational expertise.  Experience planning and delivering global clinical programs and studies
  • Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality)
  • Experience in participating or facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Enjoys building relationships with KOLs and site personnel, with a willingness to travel to establish and build relationships
  • Experience with engaging and working with Patient Advocacy groups beneficial
  • Experience with hiring, managing, mentoring and/or developing direct reports preferred

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.

Apply for this Job

* Required

  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Dyne Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.