Pioneering Medicines: Senior Director, Clinical Pharmacology

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner? 

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.  

About Flagship Pioneering: 

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.   

Position Summary: 

We are looking for a Senior Director for Clinical Pharmacology to provide strategic leadership and hands-on expertise for our early-stage pre-clinical and clinical programs across multiple therapeutic areas. This individual will be the subject matter expert for all aspects of clinical pharmacology, from setting modality and TPP-appropriate target candidate profiles to designing and executing on First-in-Human (FIH) through Proof-of-Concept (PoC) trials. Experience in early phase clinical development is essential. This individual would report to the VP of Project Leadership & Development, Pioneering Medicines. 

A critical focus of this role will be the strategic planning and execution of studies in collaboration with the Research & Clinical teams ensuring a seamless transition from pre-clinical to clinical stage and a robust data package for later-stage development. This role serves as a crucial link between our CMC (Chemistry, Manufacturing, and Controls), Research, DMPK and Clinical Development teams. 

An additional accountability for this role is to support the development of processes and standards, contribute to trial protocols and supporting documents (e.g., IBs, ICFs and IND components), and participate in study execution, including clinical pharmacology and pharmacometrics work streams, in close collaboration with clinical operations. This role will collaborate across groups within Pioneering Medicines and with partner companies and CROs. This individual will also provide input into clinical development for early asset companies within the Pioneering Medicines’ portfolio, to companies across the Flagship Ecosystem and into external projects being evaluated for Pipeline Development. 

Lastly, this individual may participate in product concept explorations, the iterative hypothesis generation and refinement process that Pioneering Medicines uses to develop novel medicines. Given the clinical development expertise and pharmacology training of the individual, their contribution would center around the challenges requiring solutions – both in and outside of their training and prior experience. 

Flagship is an experiment in institutional, entrepreneurial innovation practiced in the context of a small company with an insurgent mindset.  We are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort working in and contributing to a dynamic and cross-functional team environment.  The level of the role will be commensurate with the education and years of experience of the identified candidate. 

Key Responsibilities:  

• Clinical Pharmacology Strategy: Develop and execute the comprehensive clinical pharmacology strategy for early development assets, including dose selection for FIH studies, dose escalation strategies, and the overall plan for characterizing the PK/PD, safety, and tolerability of new drug candidates. Serves as the Clinical Pharmacology expert across study and program teams 

• Cross-functional integration: Collaborates with CMC, toxicology and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-human studies 

• Study Design and Execution: Contribute to the design, planning, and oversight of early-phase clinical trials, including Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), food effect, drug-drug interaction (DDI), bioavailability/bioequivalence (BA/BE), special population studies, proof of mechanism, proof of principle and proof of concept clinical trials. 

• Formulations:  

• Provide expert guidance on clinical strategies to support formulation development, including designing studies for extemporaneous formulation changes made during Phase 1/2. 

• Collaborate closely with CMC & DMPK teams to understand formulation properties and predict their in-vivo performance. 

• Analyze and interpret data from formulation bridging studies to ensure regulatory acceptance and inform future development decisions. 

• PK/PD Analysis and Modeling: Oversee and perform hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis. Utilize modeling and simulation (M&S) techniques (e.g., PopPK, PK/PD modeling) to inform study design, dose selection, and program decisions. 

• Regulatory Support: Author and review the clinical pharmacology sections of regulatory documents, including Investigator's Brochures (IBs), Investigational New Drug (IND) applications, briefing books, and agency responses. Represent the clinical pharmacology function in regulatory interactions. 

• Cross-Functional Collaboration: Serve as the clinical pharmacology lead on cross-functional development teams, providing expert input to colleagues in Clinical Operations, Biostatistics, Data Management, CMC, Regulatory Affairs, and Nonclinical Development. 

• Data Interpretation and Communication: Analyze, interpret, and clearly communicate complex clinical pharmacology data to both technical and non-technical audiences. Contribute to publications, abstracts, and presentations at scientific meetings. 

Minimum Qualifications: 

• PhD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or a related discipline; or PharmD with a fellowship in Clinical Pharmacology/Pharmacokinetics. 

• A minimum of 5-7 years of experience in the pharmaceutical/biotechnology industry with a proven track record in early clinical development (Phase 1/2a). Some small biotechnology company experience preferred. 

• Strong understanding of the interplay between CMC/formulation science and clinical pharmacokinetics. 

• Expertise in designing and interpreting a wide range of early-phase clinical pharmacology studies across various molecule formats including small molecules, peptides and biologics. 

• Proficiency with PK/PD analysis software (e.g., Phoenix WinNonlin). 

• Experience with PK/PD modeling and simulation (M&S) tools (e.g., NONMEM, R, Simcyp). 

• Broad understanding of drug development, including working knowledge of relevant ICH and GCP guidelines and regulations. 

• Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations. 

• Ability to work in a dynamic, team-based, matrixed environment. 

• Fluent in spoken and written English. 

• Ability to travel domestically and internationally as required. 

• Willing to consider unique and innovative approaches to challenging problems – able to let go of the assumption that it cannot be done. 

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.  

The salary range for this role is $213,000 - $280,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Medicines’s good faith estimate as of the date of publication and may be modified in the future.