Senior Director, DMPK

4 weeks ago

Cambridge, United States Editas Medicine Full time
Job DescriptionJob Description

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas Medicine is seeking a highly motivated DMPK scientist and a seasoned leader to join our DMPK, Nonclinical Safety and Translational Sciences (DSTS) team. In this leadership role, you would be responsible for overseeing ADME, biodistribution, PK/PD and bioanalytical activities. The successful candidate will apply their knowledge, expertise and drug development experience to advance our gene editing platform. The responsibilities include developing and implementing comprehensive drug metabolism and pharmacokinetic strategies to fully integrate with the program team’s objectives at all stages of development.

This individual will also be responsible for developing or overseeing stage-appropriate bioanalytical strategy and workflow. The ideal candidate will have strong technical skills, foundational knowledge, a broad understanding of drug discovery and development, regulatory experience and ability to work collaboratively with key partners in a matrix team structure. The individual in this role should be an independent thinker, possess a positive and team-centered mindset, and an ability to thrive in a fast-paced environment. Prior experience with lipid nanoparticle based (LNP) delivery systems and/or nucleic acid therapeutics is a plus. In this critical role, you will be an integral part of the nonclinical leadership team and will have the opportunity to help build the department to meet the business needs and to bring life-changing therapies to patients with genetic disorders.

Key Responsibilities:

As the Senior Director DMPK, you will be responsible for:

  • Leading a team of scientists focused on PK and bioanalytical workflows including overseeing method development, sample analysis, data generation, and report writing for preclinical and clinical samples.
  • Provide scientific monitoring and strategic oversight of outsourced studies to achieve efficient method transfer, troubleshooting, qualification, validation and reporting in support of drug discovery and development.
  • Develop integrated DMPK and bioanalytical strategies to fulfill program team objectives, established in partnership with project and functional team members.
  • Responsible for the design and execution of in vitro and in vivo studies to address ADME questions aligned with our overall scientific strategy.
  • Apply bioanalytical solutions to characterize ADME, PK and biodistribution properties of the drug product and address key scientific questions.
  • Accountable for establishing routine workflows for method development using techniques such as LC-MS/MS, molecular bioanalytical assays (qPCR, ddPCR) to support quantitative bioanalysis and apply innovative solutions to solve complex problems in order to advance the pipeline.
  • Ensure that the data obtained is of the highest quality, and stage appropriate.
  • Write and review bioanalytical study protocols and reports that are suitable for inclusion in registration dossiers; Contribute to IND, BLA or other regulatory packages.
  • Contribute effectively to patents, reports, and publications of scientific findings.
  • Model behaviors of a strong leader and mentor to staff members
  • Establish strong partnerships across sites and across functions; Work cross-functionally within the R&D organization.

Requirements

The ideal candidate will possess:

  • PhD in pharmaceutics, medicinal chemistry, analytical chemistry, DMPK or a relevant discipline, with a minimum of 10+ years of drug discovery experience; Bachelor’s/Master’s degrees with extensive and relevant industry experience will also be considered.
  • Extensive knowledge and experience in conducting quantitative bioanalysis using LC-MS or molecular bioanalytical techniques such as qPCR, ddPCR to support discovery and development projects.
  • Demonstrated knowledge and experience in establishing bioanalytical methods, ADME, PK/PD for a variety of therapeutic modalities, ideally in both preclinical and clinical environment.
  • Demonstrated success is serving as a functional representative on project teams.
  • Experience in leading and developing strong, technical, delivery-focused teams.
  • Experience with gene editing or gene delivery technologies and lipid nanoparticle delivery is highly desired.
  • Excellent communication skills and proven ability to collaborate with interdisciplinary teams, along with exceptional scientific thinking and problem-solving skills.
  • Ability to multi-task to meet research and development goals in a fast-paced environment.

Benefits

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

Fostering Belonging. Fueling Innovation. Transforming Lives.

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