Executive Director, Bioanalytical Development

<div class="content-intro"><h3>Company Overview:</h3> <p>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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">Role</span><span data-ccp-parastyle="Body"> Summary</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px">The Executive Director, Head of Bioanalytical Development leads the bioanalytical capabilities and works on our programs to develop, validate, and implement robust PK and immunogenicity assays that allow accelerated transition from the bench to the clinic, from discovery through IND, late-stage clinical development, and licensure. This role helps lead and build internal capability for ligand binding, mass spectrometry, and molecular assay development of PK and ADA for Dyne Therapeutics’ portfolio. In addition, this role leads the selection of strategic partner labs for the use of these assays in toxicology studies and clinical trials in keeping with all applicable regulatory expectations. This position reports to the Head of Translational Biomarkers at Dyne Therapeutics. The role works collaboratively across multiple research and clinical teams for the development, technology transfer, and oversight of vendors running those bioanalytical assays to support preclinical studies and clinical trials conducted by Dyne Therapeutics.</p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none">This role is based in Waltham, MA.  Applicants must be able to relocate to the area</span> <span data-ccp-props="{}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Primary Responsibilities</span><span data-ccp-parastyle="Body"> Include</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead and evolve the Bioanalytical Development function, overseeing assay development, validation, and implementation for PK</span><span data-ccp-parastyle="Body"> and </span><span data-ccp-parastyle="Body">immunogenicity</span> <span data-ccp-parastyle="Body">endpoints. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Develop and execute strategic plans aligned with pipeline priorities, ensuring </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> and high-quality data delivery. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Build and mentor a high-performing team with diverse technical </span><span data-ccp-parastyle="Body">expertise</span><span data-ccp-parastyle="Body"> and an innovative mindset. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Serve as the primary scientific interface with CROs and external partners, ensuring alignment on quality, timelines, and regulatory compliance. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Collaborate</span><span data-ccp-parastyle="Body"> cross-functionally with Clinical Pharmacology, </span><span data-ccp-parastyle="Body">Preclin</span><span data-ccp-parastyle="Body">ical Development</span><span data-ccp-parastyle="Body">, Regulatory Affairs, Quality Assurance, and Therapeutic Area leads to support integrated development strategies. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Ensure compliance with global regulatory standards (FDA, EMA, ICH, GCP, GLP) and contribute to regulatory filings (IND, BLA, MAA). </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Champion the adoption of </span><span data-ccp-parastyle="Body">cutting-edge</span><span data-ccp-parastyle="Body"> technologies and methodologies in bioanalysis, including ligand-binding assays, LC-MS/MS, and cell-based assays. </span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Drive continuous improvement initiatives and implement best practices in bioanalytical operations and data integrity.</span></span><span data-ccp-props="{"335559739":120}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Education and Skill</span><span data-ccp-parastyle="Body">s</span><span data-ccp-parastyle="Body"> Requirements</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Ph.D. or equivalent in Biochemistry, Pharmacology, or related field with </span><span data-ccp-parastyle="Normal (Web)">12+ years of experience in bioanalytical sciences within the biopharmaceutical industry. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Proven leadership experience managing large, multidisciplinary teams and external partnerships. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Deep </span><span data-ccp-parastyle="Normal (Web)">expertise</span><span data-ccp-parastyle="Normal (Web)"> in bioanalytical assay development for biologics and small molecules, including PK, ADA, and biomarker assays. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Strong understanding of regulatory requirements and experience supporting global regulatory submissions. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Demonstrated ability to influence cross-functional teams and drive strategic initiatives. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Excellent communication, organizational, problem-</span><span data-ccp-parastyle="Normal (Web)">solving</span> <span data-ccp-parastyle="Normal (Web)">and project management </span><span data-ccp-parastyle="Normal (Web)">skills.</span></span><span data-ccp-props="{"134233117":false,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559738":0,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Experience with overseeing vendors</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":false,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559738":0,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Experience in a fast-paced biotech environment. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Track record</span><span data-ccp-parastyle="Normal (Web)"> of innovation and scientific contributions in bioanalysis</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":false,"134233118":true,"201341983":0,"335557856":16777215,"335559685":360,"335559738":0,"335559739":120,"335559740":360,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> </ul> <p> </p> <p>#LI-Onsite</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$241,530</span><span class="divider">—</span><span>$295,850 USD</span></div></div></div><div class="content-conclusion"><p> </p> <p>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.</p> <p>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.</p> <p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">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.</span></em></p></div>