Director/Associate Director, Translational DMPK & Clinical Pharmacology; Biologics
Listed on 2026-10-15
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Healthcare
Clinical Research, Medical Science -
Research/Development
Clinical Research, Medical Science
Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential entering clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.
This is a unique opportunity to join a science-driven company at a formative stage, where early clinical data will directly shape development strategy and drive long-term value. The right candidate will join a team with significant development experience, with the goal of quickly moving through dose escalation/expansion into pivotal trials.
The Role:We are seeking a Director or Associate Director to lead translational DMPK and clinical pharmacology/pharmacometrics strategy for our biologics pipeline, spanning discovery/IND-enabling studies through clinical development. This individual will serve as the DMPK and clinical pharmacology lead for one or more biologics programs (monoclonal antibodies, bispecifics), owning the PK/PD strategy from nonclinical species through first-in-human and beyond, driving model-informed drug development (MIDD), translational dose prediction, dose selection, and regulatory submissions.
The successful candidate will partner cross-functionally with Discovery/Nonclinical, Clinical Operations, Bioanalytical, Biostatistics, and Regulatory Affairs to accelerate program timelines through quantitative decision-making. The role reports to the VP, Clinical Pharmacology and Pharmacometrics.
We welcome applicants from both large- and small-molecule backgrounds. If you are an experienced clinical pharmacologist or pharmacometrician who is excited to build deep biologics expertise, we encourage you to apply. You will be supported by a team and leadership with large-molecule experience.
What You’ll Do:Nonclinical / Translational DMPK
- Design and oversee in vivo PK/ADME and in vitro studies for biologics, including species selection, dose/route rationale, and sample analysis plans
- Lead translational strategy to bridge nonclinical and clinical data, including interspecies/allometric scaling and first-in-human dose prediction
- Support IND-enabling nonclinical PK and toxicokinetic study design, analysis, and interpretation
- Characterize biologics-specific disposition mechanisms (FcRn-mediated recycling, target-mediated drug disposition, catabolism, immunogenicity impact on PK)
Clinical Pharmacology & Pharmacometrics
- Design and lead clinical pharmacology strategy for biologics programs, including first-in-human dose selection, clinical study design, and dose/schedule optimization
- Develop and apply population PK/PD, exposure-response, and TMDD models to inform go/no-go decisions and regulatory filings
- Oversee the bioanalytical team for PK and ADA/immunogenicity sample analysis across nonclinical and clinical stages
- Lead quantitative systems pharmacology (QSP) or mechanistic modeling efforts as applicable to program needs (e.g., FcRn recycling, receptor occupancy, immune/heme cell dynamics)
Regulatory & Cross-Functional
- Author and review DMPK and clinical pharmacology sections of IND/CTA, briefing documents, and BLA/NDA submissions
- Interface with FDA/EMA on DMPK and clinical pharmacology strategy, including meeting package preparation and responses to health authority questions
- Represent DMPK/Clinical Pharmacology on cross-functional program teams and portfolio governance forums
- Evaluate and manage external modeling, DMPK, and bioanalytical consulting vendors as needed
- PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacokinetics/DMPK, Pharmacometrics, Pharmacology, or related quantitative discipline (or MS with extensive relevant industry experience)
- 8+ years (Director) or 6+ years (Associate Director) of industry experience in DMPK and/or clinical pharmacology/pharmacometrics. Biologics experience is strongly preferred; candidates with a strong small molecule background and a demonstrated ability to learn large-molecule pharmacology are encouraged to apply
- Experience designing and interpreting nonclinical in vivo PK and ADME studies and translating findings into human dose…
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