Director, DMPK

Company: Moderna Therapeutics
Location: Cambridge
Posted on: May 24, 2023

Job Description:

The Role:
The Moderna Non-Clinical Sciences team is looking for a talented, curious, and motivated scientist with a track record of pharmaceutical project support to lead the DMPK group. The Director, DMPK will oversee DMPK support for LNP-mRNA therapeutic projects across multiple disease areas and the platform. The position will help in defining a strategy to refining the application of ADME and PK principles to this novel therapeutic modality. The candidate will mentor direct reports and serve as their coach to help with their career development and aspirations. The successful candidate will apply DMPK expertise in a dynamic team setting to inform discovery and development phase therapeutic LNP-mRNA project decisions and provide DMPK guidance to ensure successful candidate transition into clinical testing. Applicants should be self-starters with well-developed communication and influencing skills who have demonstrated the ability to work effectively in a team driven, rapidly evolving, interactive scientific environment. - Here's What You'll Do:

• Define DMPK strategy for platform and multiple disease areas.
• Interact with different stakeholders to ensure DMPK input is provided in a timely fashion.
• Mentor and coach direct reports.
• Understand, use, and explain PK/ADME principles to inform and guide the design, assessment, and selection of clinically viable LNP-mRNA therapeutic candidates to discovery project teams
• Effectively engage with the project team to inform and influence study/experimental designs and project decisions, develop and execute DMPK scientific plans, and critically review/assess quality of team data and their suitability to inform project decisions
• Integrate DMPK information into the broader project and DMPK functional scientific and operational context and identify when appropriate scientific experts are needed to address DMPK concerns in shaping and executing successful therapeutic strategies
• In collaboration with partner disciplines support determination of FIH dose
• Oversee the writing of Sections 2.4, 2.6.4 and 2.6.5 and other appropriate documents to support IND and other regulatory filings
• In collaboration with partner functions devise and implement therapeutic DMPK strategies
• Actively engage with the DMPK team to increase understanding of and to communicate PK, ADME and DDI relevance to LNP-mRNA therapeutic development
• Expected to engage appropriate scientific experts to address DMPK concerns and ensure that the project team has direct access to these experts where appropriate to efficiently share information and answer project questions.Here's What You'll Bring to the Table:
  • PhD in Pharmaceutical sciences, Chemistry, Biochemistry, or related field with 10+ years of BioPharma industrial experience in DMPK
  • Familiarity with DMPK and ADME principles and standard industry practices pertaining to PK, ADME, and DDI of drugs
  • Have direct DMPK project representation experience in biopharma
  • Excellent verbal and written communication skills
  • Experience with biomolecule, gene therapy, or mRNA therapeutics is a plus
  • Demonstrated experience with PK and PKPD modeling software(s) is a plus
  • Experience in regulatory document writing and regulatory interactions
  • Candidate will be diligent in documenting and communicating experimental methods/results, curious in exploring science to establish a new path for drug discovery/development and bold in proposing creative experimental designs and DMPK functional strategies. Will work collaboratively with multifunctional teams and will be relentless in transforming LNP-mRNA therapeutic scientific understanding while delivering successful clinical candidates.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
    • Highly competitive and inclusive medical, dental and vision coverage options
    • Flexible Spending Accounts for medical expenses and dependent care expenses
    • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
    • Family care benefits, including subsidized back-up care options and on-demand tutoring
    • Free premium access to fitness, nutrition, and mindfulness classes -
    • Exclusive preferred pricing on Peloton fitness equipment
    • Adoption and family-planning benefits
    • Dedicated care coordination support for our LGBTQ+ community
    • Generous paid time off, including:
      --- Vacation, sick time and holidays
      --- Volunteer time to participate within your community
      --- D iscretionary year-end shutdown
      --- Paid sabbatical after 5 years; every 3 years thereafter
    • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
    • 401k match and Financial Planning tools
    • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
    • Complimentary concierge service including home services research, travel booking, and entertainment requests
    • Free parking or subsidized commuter passes
    • Location-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About ModernaIn over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-MBB1- About UsOur Mission and VisionAt Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.Third Party Staffing AgenciesM oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation NoticeModerna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Director, DMPK, Executive , Cambridge, Massachusetts