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Director​/Associate Director, Translational DMPK & Clinical Pharmacology; Biologics

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Damora Therapeutics
Full Time position
Listed on 2026-10-15
Job specializations:
  • Healthcare
    Clinical Research, Medical Science
  • Research/Development
    Clinical Research, Medical Science
Salary/Wage Range or Industry Benchmark: 180000 - 260000 USD Yearly USD 180000.00 260000.00 YEAR
Job Description & How to Apply Below
Position: Director / Associate Director, Translational DMPK & Clinical Pharmacology (Biologics)

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
What You’ll Bring :
  • 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…
Position Requirements
10+ Years work experience
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