Snr-ED Clinical Pharmacology and Pharmacometrics (I&I)

EPM Scientific; Boston (MA); On-site; USD 280,000 - 360,000; Full time

Job summary

EPM Scientific seeks a Senior Director / Executive Director of Clinical Pharmacology & Pharmacometrics to establish and lead strategy across a growing pipeline in Immunology & Inflammation. The role combines scientific rigor with entrepreneurial scale-building within a rapidly growing biotech.

Located in Boston, MA or Philadelphia, PA, the candidate will drive quantitative development, lead external vendors, and partner across Regulatory, Safety, and Biostatistics to inform dose selection and

Qualifications

• PhD/MD/PharmD with leadership in Clinical Pharmacology, Pharmacometrics or MIDD.
• Extensive experience in large global pharma or biotech development settings.
• Strong background in PK/PD modeling, exposure–response, and regulatory interactions.

Responsibilities

• Lead global Clinical Pharmacology, Pharmacometrics, and MIDD strategies across the portfolio.
• Integrate PK/PD data, biomarkers, and safety findings into development decisions.
• Provide FIH dose selection, dose escalation, and formulation guidance.
• Lead regulatory submissions and interactions with global health authorities.

Skills

Clinical Pharmacology

Pharmacometrics

MIDD

PK/PD Modeling

Leadership

Education

PhD, PharmD, MD or equivalent in Clinical Pharmacology/Pharmacometrics

Job description

Snr-ED Clinical Pharmacology and Pharmacometrics (I&I) (PR/617997) Boston, Massachusetts

Salary: USD280000 - USD360000 per year

Senior Director / Executive Director, Clinical Pharmacology & Pharmacometrics

Location: Philadelphia, PA or Boston, MA
Therapeutic Area: Immunology & Inflammation

The Opportunity

A rapidly scaling, innovative biotechnology company is seeking a Senior Director / Executive Director of Clinical Pharmacology & Pharmacometrics to establish and lead Clinical Pharmacology, Pharmacometrics, and Model-Informed Drug Development strategy across its growing pipeline.

The organization is leveraging AI-enabled drug discovery, advanced disease biology, and biologics engineering to develop differentiated therapies for difficult-to-treat immune-mediated diseases. The company is approaching an important stage of growth as its first wave of therapeutic programs advances from preclinical development toward the clinic and clinical proof of concept.

This is a highly visible leadership opportunity for an accomplished Clinical Pharmacology leader who combines the scientific and development rigor of large pharma with the entrepreneurial mindset needed to build capabilities within a scaling biotech.

Key Responsibilities

Clinical Pharmacology & MIDD Strategy

• Develop and lead global Clinical Pharmacology, Pharmacometrics, and MIDD strategies across the portfolio.
• Integrate nonclinical and clinical PK/PD, exposure-response, biomarkers, efficacy, safety, and immunogenicity data into development decisions.
• Provide quantitative recommendations around FIH dose selection, dose escalation, dosing frequency, formulation, DDI, food effect, and special populations.
• Establish quantitative development strategies spanning candidate selection through proof of concept and later-stage development.

Pharmacometrics & Quantitative Sciences

• Lead population PK, PK/PD, exposure-response, PBPK, translational modeling, and clinical trial simulation.
• Apply modeling and simulation to inform trial design, dose optimization, therapeutic exposure targets, and portfolio decisions.
• Explore advanced quantitative approaches including QSP, disease-progression modeling, and model-based meta-analysis.

Translational & Early Clinical Development

• Translate nonclinical pharmacology, DMPK, toxicology, bioanalytical, and biomarker findings into human PK projections, therapeutic exposure targets, and safety margins.
• Drive Clinical Pharmacology strategy throughout IND/CTA-enabling development, FIH, dose escalation, and clinical proof of concept.
• Partner closely with Clinical Development, Translational Medicine, DMPK, CMC, Biomarkers, Regulatory, Safety, Biostatistics, and Clinical Operations.
• Provide Clinical Pharmacology leadership across biologic programs involving considerations such as TMDD, immunogenicity, body-size effects, and IV versus subcutaneous administration.

Dose Optimization & Regulatory Strategy

• Integrate emerging pharmacokinetic, pharmacodynamic, efficacy, safety, biomarker, and immunogenicity findings to drive dose and regimen selection.
• Develop clear quantitative pathways from early development through registration.
• Lead Clinical Pharmacology components of regulatory submissions and interactions with global health authorities.
• Defend dose-selection, exposure-response, special-population, and model-informed development strategies with agencies including the FDA and EMA.

Functional Leadership

• Build a scalable Clinical Pharmacology and Pharmacometrics capability utilizing internal resources, external experts, consultants, and specialized vendors.
• Establish fit-for-purpose quantitative workflows, modeling standards, documentation, and governance.
• Lead external pharmacometrics, bioanalytical, and modeling vendors.
• Serve as the senior Clinical Pharmacology voice on development and portfolio governance committees.

Ideal Candidate Profile

We are particularly interested in candidates who combine large-pharma Clinical Pharmacology training with deep Immunology & Inflammation expertise.

Required / Preferred Background

• PhD, PharmD, MD, or equivalent advanced degree within Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Pharmacokinetics, or a related quantitative discipline.
• Significant pharmaceutical/biotechnology experience leading Clinical Pharmacology, Pharmacometrics, or MIDD activities.
• Extensive experience within a large global pharmaceutical organization strongly preferred.
• Deep therapeutic expertise within Immunology & Inflammation, ideally with exposure to areas such as:
  • Immunology
  • Autoimmune / immune-mediated disease
  • Rheumatology
  • Dermatology
  • Gastroenterology
  • Respiratory / inflammatory disease
• Demonstrated experience advancing assets from preclinical development through FIH, proof of concept, dose optimization, and later-stage clinical development.
• Strong hands-on understanding of population PK, PK/PD, exposure-response modeling, modeling and simulation, and MIDD.
• Experience supporting biologics, including monoclonal antibodies or multispecific molecules, highly desirable.
• Experience authoring Clinical Pharmacology regulatory content and presenting or defending Clinical Pharmacology strategies before global regulatory authorities.
• Experience operating within global development environments and influencing complex, cross-functional teams.

Leadership Profile

The ideal candidate is both a scientific authority and strategic drug-development leader.

This individual should be capable of moving between sophisticated quantitative analyses and executive-level portfolio discussions, translating complex modeling outputs into clear clinical development decisions.

Importantly, the successful candidate will bring the discipline, infrastructure, and global development perspective gained within large pharma, while being energized by the opportunity to operate more entrepreneurially and build within a rapidly scaling biotechnology organization.

Why Consider This Opportunity?

This is an opportunity to join an emerging biotech at an important inflection point and have significant influence over how its clinical development organization is built.

Rather than inheriting a narrowly defined Clinical Pharmacology role, this leader will have the opportunity to shape MIDD strategy, dose selection, clinical development decisions, regulatory positioning, external capabilities, and the broader quantitative development philosophy supporting an innovative I&I portfolio.

Candidates must be based in, or able to work from, Philadelphia, PA or Boston, MA.

Salary: 280-360,000 base + additional incentives