Director – Dmpk

Company Summary

What if…you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainability?

Prologue Medicines is dedicated to transforming drug discovery by leveraging deep biological insights and cutting-edge scientific innovations. Our mission is to deliver breakthrough therapies that address critical unmet medical needs. As part of our dynamic and collaborative team, you will have the opportunity to impact human health on a global scale.

Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. Many of the companies Flagship has founded 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.

Position Overview:

Prologue Medicines is seeking an exceptional individual and scientist to join and lead our Drug Metabolism and Pharmacokinetic (DMPK) group. The successful candidate will be accountable for setting the DMPK strategy and driving execution to advance projects from early discovery through preclinical development. This role will support DMPK, ADME, and regulated bioanalysis activities across research and early clinical-stage drug development programs, including interactions with CROs and internal project stakeholders.

This individual will be responsible for representing their function on study and project teams and may participate in regulatory interactions. Deep expertise in PK/ADME strategies and tactics in biologics drug discovery and preclinical development is foundational to this role, along with hands-on experience in PK and PK/PD modeling. You will thrive in a collaborative, fast-paced, interdisciplinary team environment.

Key Responsibilities

• Lead the DMPK, Pharmacology and regulated bioanalysis activities.

• Provide Pharmacology, PK/PD, and DMPK expertise at all stages of discovery and nonclinical development for all programs including biologics.

• Conduct PK and PK/PD, PBPK modeling, and offer predicted human PK, efficacious dose projections, and drug-drug interaction (DDI) or similar risk assessments as needed.
• Strong knowledge of regulated bioanalytical methods and current guidance. Familiarity with both LC-MS/MS and ligand binding assay (LBA) method development is a plus.
• Drive assessment of correlation between exposure & efficacy as well as exposure & toxicity. Provide lead efforts to the DMPK strategy and drive execution to advance projects from early discovery through preclinical development.

• Balance the internal infrastructure and capabilities vs. outsourcing; maintain an effective network of outside partners, collaborators and service organizations. Including but not limited to overseeing execution of studies at CRO labs along with evaluation of protocols, results and related reports.

• Provide SME support for collaborations on large animal studies along with execution of CRO selection and supervision for toxicology studies as well as the design of non-GLP and GLP studies including NHP studies.

• Partner with Nonclinical development to ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development.

• Provide recommendations to senior management of other line functions regarding key program decisions.

• Provide SME support for regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority (FDA, EMA, PMDA) interactions, and experience in developing strategies around those interfaces in collaboration with the Regulatory function.

• Provide support to Tech Ops (Manufacturing/CMC) to problem solve real-time issues with drug substance/drug product in stages of nonclinical development.

• Ensure high quality review of key study documents, including protocols, study reports, regulatory documents, publications, and formal and informal presentations of study data.

• Represent DMPK during interactions/presentations with Regulatory Agencies as a subject matter expert and thought leader. Develop and maintain relationships with KOLs, researchers, and academics.

• Leader/coach/mentor of other project representatives in the team.

• Foster and ensure a culture of transparency of progress against department infrastructural goals and various team goals, by modeling best practice for risk and issue identification, communication, and mitigation/management.

Qualifications:

Education:

• Ph.D. in pharmaceutical science, biochemistry, or a related field with 8+ years of relevant experience, OR MS/BS with 10+ years of relevant experience. Expert knowledge of commonly used software for PK/PD, PBPK, PBPK-PD, & QSP modeling required.

Experience:

• Minimum 8+ years of experience, with 6+ yrs. in industry, leading and representing the DMPK function on project teams, especially in discovery and early development.

• Extensive knowledge of biologics drug metabolism, pharmacokinetics (PK), and relevant analytical techniques.

• Strong understanding of the analytical methods in biologics, drug discovery workflow; knowledge of biologics along with novel modalities.

• Hands-on experience conducting, troubleshooting, and summarizing in vitro and in vivo ADME/DMPK studies.

• Familiarity with regulatory guidelines related to DMPK in drug development is desirable.

• Demonstrated DMPK expertise through high-quality peer-reviewed publications is a plus.

• Experience in outsourcing and external oversight of nonclinical DMPK/ADME studies is desirable.

• Expert in common software for PBPK, PBPK-PD, & QSP modeling required.
• Leadership experience in an industry setting growing and developing talent and building a team

Skills:

• Strong attention to detail and commitment to quality.

• Excellent communication skills, both interpersonal and in data presentation.

• Ability to adapt to a fast-paced and dynamic work environment.

• Proven ability to work successfully in cross-functional teams with a focus on teamwork, collaboration, and communication.
• Forward-thinking mindset with the ability to manage multiple projects simultaneously and identify and resolve issues efficiently.

At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

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.