Associate Director, Nonclinical Out-Sourcing

Dyne Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 12/29/2020
  • Website: dyne-tx.com
  • Company Address: 400 Technology Square 10th Floor, Cambridge, MA, 02139

About Dyne Therapeutics

Dyne was founded with a singular focus: to transform the lives of people with serious muscle diseases by pioneering muscle-targeted therapies. Our proprietary technologies provide the foundation for breakthrough treatments. We have assembled a world-class team of experts who are united by their commitment to fulfill this mission.

Job Description

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Reporting to the Vice President, Head of Preclinical Development (PCD), the Associate Director, Nonclinical Out-Sourcing will be responsible for continuing and enhancing Dyne’s partnerships with contract research organizations (CROs) and identifying areas for strategically enhancing PCD operations. The incumbent will also support multiple preclinical programs and be responsible for establishing and maintaining effective sourcing of nonclinical studies by setting clear expectations, establishing proactive and regular channels of communication, and in-person study monitoring, leading to timely delivery of high-quality study reports from CROs. The candidate should possess an in-depth understanding of Good Laboratory Practices (GLP) as they pertain to the execution and finalization of non-GLP and GLP compliant studies in support of preclinical programs. The ideal candidate should have experience as a study director/monitor on GLP compliant studies and have direct experience in working with CROs. The ability to work collaboratively with cross-functional teams is critical for this position.

Primary Responsibilities Include:

Vendor Management and Out-Sourcing Strategy

  • Play a lead role in defining and expanding the scope of preclinical operations and implementing processes to gain efficiencies
  • Meet with new CRO reps to assess capabilities in relation to Dyne’s needs, and build a supporting relationship between Dyne and its vendors
  • Meet with CRO Business Development reps to secure pricing discounts and preferred provider status benefits
  • Remain updated on CRO environment and anticipate industry trends to position Dyne as a preferred partner with CROs
  • Establish quality processes for all aspects of out-sourced studies including partnering with Dyne QA to establish phase-appropriate processes for initiation of FIH-enabling studies
  • Perform vendor and study staff qualification by review of facility SOPs, EIRs, and staff training records
  • Lead resolution discussions between Dyne and CROs as issues arise
  • Maintain metrics on study costs, discounts received, deliverable timeliness, and records of errors on outsourced studies, for communication to executive leadership
  • Attend conferences to remain up to date on latest CRO capabilities and regulatory expectations

Study Coordinator/Monitor

  • Align with PCD colleagues on the design and timing of studies needed to support key clinical milestones
  • Obtain initial pricing for individual studies or programs from CROs and schedule studies to meet program timelines
  • Work closely with relevant Dyne colleagues and CROs to coordinate and track all study-related documentation, specimen shipment, reporting timelines and archiving by maintaining appropriate file management and document control for assigned programs including timely delivery of final reports and SEND datasets
  • Enable effective communication channels between CRO study directors, and other study personnel, and program toxicologists
  • Travel to CROs to monitor procedures on active studies as needed and as coordinated with program toxicologists

Education and Skill Requirements:

  • B.S. / M.S. or equivalent in biology, biochemistry, toxicology or a related field
  • 8 or more years of experience in a biopharmaceutical company
  • Experience as a study director and/or study monitor in a preclinical toxicology group
  • Experience in out-sourcing of bioanalytical method development, validation and analyses is a plus
  • Demonstrated understanding of GLP requirements for the conduct on toxicology studies
  • Experience qualifying and/or auditing CROs for selection of executing nonclinical toxicology studies
  • Experience in setting and managing budget to enable timely project execution
  • Excellent communication and interpersonal skills including superior understanding of Microsoft Office products
  • Willingness to travel to CROs
  • Excellent organizational skills that enable the ability to manage multiple projects with attention to detail
  • Capacity to complete tasks independently in a highly regulated environment
  • Flexibility to function well within a team environment and within condensed timelines
  • Ability to verbalize complex study issues and demonstrated problem-solving ability

 

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.

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.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.