Head of Clinical Pharmacology

The Steely Group; Lexington (MA); Hybrid; USD 250,000 - 400,000; Full time

Job summary

The Steely Group is seeking an accomplished Clinical Pharmacology leader to guide strategy across an oncology development portfolio. Reporting to the CMO, this executive will shape clinical pharmacology strategies supporting programs from early clinical evaluation through global registration.

Lead dose selection, PK/PD analyses, exposure‑response modeling, and regulatory strategy to drive data‑driven development decisions.

Qualifications

• Advanced degree in Clinical Pharmacology or related field.
• At least 12 years of industry experience in oncology drug development.
• Experience leading pharmacology activities from FIH to late-stage development and IND support.

Responsibilities

• Define and oversee clinical pharmacology strategies across oncology assets.
• Lead dose selection, dose optimization, food effect studies, DDIs, and cardiac safety assessments.
• Apply model-informed drug development and PK/PD analyses to optimize strategies.
• Prepare content for protocols, CSRs, regulatory submissions, and agency responses.
• Represent pharmacology in regulatory interactions (FDA and international authorities).
• Mentor team members and build the Clinical Pharmacology function.

Skills

Strategic leadership

Cross-functional leadership

Model-informed drug development

Pharmacology expertise

Education

PhD/PharmD/MD or equivalent

Tools

PBPK modeling

QSP

Pharmacometric modeling

Population PK

Job description

We are seeking an accomplished Clinical Pharmacology leader to guide the strategic direction of clinical pharmacology across the oncology development portfolio. Reporting to the Chief Medical Officer, this executive will be responsible for shaping clinical pharmacology strategies that support programs from early clinical evaluation through global registration. The successful candidate will lead initiatives related to dose selection and optimization, pharmacokinetic and pharmacodynamic analyses, exposure-response modeling, and regulatory strategy while helping drive data-informed development decisions. This individual will play an integral role within the Clinical Development leadership team and will collaborate across scientific and operational functions to ensure quantitative clinical pharmacology is embedded throughout the development process. This is an opportunity for an experienced scientist who enjoys working in a dynamic biotechnology environment, building organizational capabilities, and contributing to the advancement of innovative oncology therapies. The ideal candidate combines scientific depth, strategic thinking, and collaborative leadership with a passion for translating complex data into meaningful development decisions.

Primary Responsibilities

Define and oversee clinical pharmacology strategies supporting current and future oncology assets throughout the product development lifecycle. Serve as the organization's senior subject matter expert in clinical pharmacology and provide strategic guidance to executive leadership. Lead development plans addressing dose selection, dose optimization, food effect studies, drug‑drug interactions, cardiac safety assessments, organ impairment evaluations, and special population considerations. Apply model‑informed drug‑development approaches, including pharmacokinetic/ pharmacodynamic modeling, population PK analyses, exposure‑response assessments, and pharmacometric methodologies to optimize development strategies. Direct preparation and scientific review of clinical pharmacology content for protocols, Investigator's Brochures, Clinical Study Reports, regulatory submissions, briefing packages, and health authority responses. Represent the clinical pharmacology function during interactions with regulatory agencies, including the FDA and international authorities. Work closely with Clinical Development, Translational Sciences, Biomarkers, Regulatory Affairs, Biostatistics, Clinical Operations, Data Management, Medical Writing, and other cross‑functional partners to support integrated development plans. Provide scientific leadership for study design, protocol development, program governance, and key portfolio decisions. Oversee external collaborators, contract research organizations, and specialized modeling partners to ensure timely, high‑quality execution. Build and develop the Clinical Pharmacology function by establishing best practices, mentoring team members, and strengthening organizational capabilities. Monitor scientific advancements and emerging technologies in clinical pharmacology to enhance development programs and future pipeline opportunities. Present scientific strategies, analyses, and recommendations to senior leadership, governance committees, regulatory agencies, scientific conferences, and external collaborators.

Qualifications

Required Advanced degree (PhD, PharmD, MD, or equivalent) in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, or a related scientific discipline. At least 12 years of industry experience supporting drug development within biotechnology or pharmaceutical organizations, including significant experience in oncology. Proven leadership of clinical pharmacology activities spanning first‑in‑human studies through later stages of clinical development. Extensive knowledge of pharmacokinetics, pharmacodynamics, population PK, exposure‑response analyses, modeling and simulation, and dose optimization strategies. Experience supporting Investigational New Drug (IND) applications and collaborating with regulatory agencies such as the FDA and other international authorities. Strong understanding of global regulatory expectations, including FDA, EMA, and ICH clinical pharmacology guidance. Demonstrated ability to influence development strategy and lead cross‑functional initiatives in a matrixed environment. Experience working with small‑molecule oncology therapeutics. Outstanding written, verbal, presentation, and leadership skills. Preferred: Experience with precision medicine or biomarker‑guided oncology development programs. Familiarity with physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), or related advanced modeling methodologies. Experience contributing to major global marketing applications, including NDA, BLA, or equivalent submissions. Previous success creating, expanding, or leading a Clinical Pharmacology function within an emerging biotechnology organization.