Pioneering Medicines: Scientific Director, DMPK

ABOUT PIONEERING MEDICINES

Pioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

Position Summary:

We are seeking a skilled DMPK Scientific Director to support across our diverse drug discovery portfolio targeting a broad range of disease areas and therapeutic modalities. In this role, you will apply knowledge and technical expertise in in vitro and in vivo ADME and PK to drive project team strategy. You will work collaboratively with discovery and development teams to establish optimal lead candidate characteristics, develop ADME/PK strategies, and execute preclinical studies intended to characterize potential drug candidates. We are seeking individual who is analytical, goal-oriented, independent, swift, and committed to maintaining the highest scientific and ethical standards. A minimum of 5 years experience as a DMPK project representative on cross-functional teams is required. 

Key Responsibilities:

• Represent the DMPK function on cross-functional discovery teams and provide technical and scientific expertise for ADME profiling and interpretation of the data.
• Define strategy for in vitro/in vivo DMPK and DDI risk assessment for drug candidates.
• Strategically design and lead ADME/PK studies, critically analyze and interpret data, identify issues, and help overcome technical challenges.
• Coordinate and interact with matrix project team members for planning and executing DMPK-related activities.
• Collaborate with PK/PD modelers to establish PK/PD correlations and guide preclinical study design.
• Contribute to the selection of preclinical tox species and toxicokinetic plan to support IND.
• Support human dose projections based on preclinical data to guide candidate selection.
• Author ADME/DMPK sections of regulatory documents (e.g., IND/IB).
• Contribute to the development of functional processes and procedures focused on CRO interactions and organizational efficiency.
• Conduct scientific presentations to senior management, project teams, and internal/external collaborators.
• Provide operational oversight for quality and performance of DMPK activities, including interactions with CROs and external project support.
• Contribute to the selection and qualification of CROs and vendors.
• Closely interact with key internal stakeholders and Flagship ecosystem companies

Basic Qualifications:

• Ph.D. in pharmaceutical science, biochemistry, or related scientific discipline wit 7+ years or MS/BS with 10+years of relevant experience
• 5+ years experience leading representing DMPK function on project teams, particularly in discovery and early development
• Extensive knowledge of drug metabolism, PK, and relevant analytical techniques is required.
• Strong understanding of small molecule drug discovery workflow is required; understanding of biologics/novel modalities is desirable.
• Hands on experience conducting, troubleshooting, and summarizing in vitro and in vivo ADME/DMPK studies is required.
• Familiarity with regulatory guidelines and requirements related to DMPK in drug development is desirable.
• Demonstrated DMPK skills through high quality peer-reviewed publications is desirable.
• Experience in outsourcing and external oversight of nonclinical DMPK/ADME studies is desirable.
• Attention to detail and quality are critical to success.
• Excellent communication skills including interpersonal skills and data presentation skills.
• Demonstrated ability to adapt to a fast-paced and dynamic work environment.
• Demonstrated ability to successfully work in cross-functional teams with an emphasis on teamwork, collaboration, and communication within team and across the department.
• Forward thinking mindset with demonstrated ability to manage multiple projects and identify and resolve issues.

 

LOCATION:  Cambridge, MA

ABOUT FLAGSHIP PIONEERING

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com. 

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

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