Director / Associate Director, Translational DMPK & Clinical Pharmacology (Biologics)

Damora Therapeutics; Waltham (MA); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

Damora Therapeutics is seeking a Director or Associate Director to lead translational DMPK and clinical pharmacology/pharmacometrics strategy for its biologics pipeline, spanning discovery through clinical development. You will own the PK/PD strategy from nonclinical species through first‑in‑human and beyond, driving model‑informed drug development and dose prediction.

The role partners with Discovery/Nonclinical, Clinical Operations, Bioanalytical, Biostatistics, and Regulatory Affairs to

Qualifications

• PhD, PharmD, or equivalent in Pharmaceutical Sciences or related field.
• 8+ years (Director) or 6+ years (Associate Director) in DMPK or clinical pharmacology/pharmacometrics.
• Experience designing and interpreting nonclinical PK/ADME studies and translating findings to humans.

Responsabilités

• Lead nonclinical translational DMPK strategy and in vivo/in vitro PK/ADME studies.
• Bridge nonclinical and clinical data with interspecies scaling and first-in-human dose prediction.
• Design IND-enabling nonclinical PK and toxicokinetic studies and interpret results.
• Characterize disposition mechanisms specific to biologics (FcRn recycling, TMDD, immunogenicity impact).
• Lead clinical pharmacology strategy for biologics programs and dose optimization.
• Develop population PK/PD, exposure–response, and TMDD models to inform go/no-go decisions and regulatory filings.
• Oversee bioanalytical PK/ADA analyses across stages and vendors as needed.
• Lead QSP or mechanistic modeling efforts for program needs.

Connaissances

Translational DMPK

Clinical pharmacology

PK/PD modeling

MIDD

Regulatory submissions

Biologics expertise

R and Python

Formation

PhD, PharmD or equivalent

Pharmacokinetics/DMPK training

Outils

NONMEM

Monolix

nlmixr2

Pumas

mrgsolve

R

Python

Description du poste

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 predictions (small or large molecule)
• Demonstrated expertise in population PK/PD and exposure-response modeling using tools such as NONMEM, Monolix, nlmixr2, Pumas, or mrgsolve
• Track record of authoring DMPK and/or clinical pharmacology regulatory documents (IND/CTA, NDA/BLA, briefing packages), with direct health authority interaction a plus
• Strong working knowledge of R and/or Python for PK/PD analysis and data visualization
• Excellent written and verbal communication skills; ability to translate quantitative findings for non-technical stakeholders
• Experience using model-based methods to answer translational PK/PD questions

A plus if you have:

• Hands-on experience with large-molecule-specific challenges: TMDD, FcRn-mediated disposition, interspecies scaling for biologics, immunogenicity impact on PK, or bispecific PK/PD
• Experience with Fc-engineered biologics and bispecifics
• Experience with mechanistic/QSP modeling, or with first-in-human dose selection for oncology or immuno-oncology agents

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.

Agency Policy

We are building our team intentionally and do not accept unsolicited resumes from recruiting or staffing agencies. Agencies should not submit candidates unless directly engaged by Damora’s HR team and operating under a signed agreement. Any resume submitted without prior authorization and a signed agreement will be considered property of Damora Therapeutics, and no referral or placement fees will be paid.