Senior Director, Quantitative Pharmacology

As a leadership role in the Quantitative Pharmacology team at Quantitative Translational Research (QTR), you will oversee clinical pharmacology activities, assist in department technical growth, and contribute to key success metrics of the Clinical Pharmacology team across all stages of clinical development.

Responsibilities

• Support the Head of Quantitative Pharmacology in managing and growing the function team, mentoring and training junior scientists, and overseeing project-level clinical pharmacology activities.
• Lead the development of SOPs, work practices, or cross-functional working processes.
• Oversee clinical pharmacology deliverables related to pre-IND, IND, Phase 1-3, Pharmacokinetics (PK), Pharmacokinetics-Pharmacodynamics (PK/PD) reports, and regulatory submissions.
• Review and approve Clinical Pharmacology reports and analyses.
• Oversee clinical pharmacology strategy and provide input into clinical development strategy for all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development.
• Serve as Clinical Pharmacology Lead in Early- and Late-stage development teams, providing data-driven actionable plans and communicating results and strategy to development teams.
• Oversee interactions of the clinical pharmacology team with other QTR functions (non-clinical toxicology, DMPK, bioanalytical, and biomarker teams) for the design, execution, and reporting of clinical studies, especially first-in-human and clinical pharmacology studies.
• Review business development opportunities and make go/no-go recommendations on behalf of QTR.
• Work with the QTR leadership team to set department strategy, growth, and cross-functional alignment.
• Serve as clinical pharmacology lead on multiple cross-functional project teams; plan and optimize clinical pharmacology strategies and integrate them into clinical development plans.
• Review, approve, and lead the development of clinical pharmacology sections for regulatory filings, including annual reports, investigator’s brochures, IND/NDA/BLA applications, and pediatric development plans.
• Work closely with the pharmacometrics team to support model-based drug development (MIDD) strategies and provide input to PK and PK/PD modeling analysis for dose selection, efficacy, and safety assessments.
• Collaborate with the Translational and biomarker team to support biomarker development and incorporation into early-phase studies.
• Use innovative data analysis methods to integrate knowledge of PK, PD, patient characteristics, and disease states to optimize doses, dosage regimens, and study designs in collaboration with pharmacometrics, biomarker, statistics, and clinical development functions.
• Review and approve clinical study design and protocols for healthy subject trials (including FIH SAD/MAD, DDI, rBA, mass-balance, HI/RI, TQT).
• Interact cross-functionally with disciplines such as nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC.
• Work with formulation, biomarker, and bioanalytical teams on activities related to formulation development, assay development, sample management, Pharmacogenomics (PGx), and biomarker strategy development.
• Train and manage junior team members in the Quantitative Pharmacology team.
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow.

Requirements

• PhD in Clinical Pharmacology or a related area (e.g., pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 12 years of experience.
• Experience in early-phase clinical protocol development is a plus.
• Travel: 20-40%.

Skills

• Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving: Make decisions considering the long-term impact on customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain an ongoing focus on the needs of customers and key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results.
• Respectful Collaboration: Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development: Play an active role in professional development as a business imperative.

Pay

Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the U.S. Other elements may be used to determine actual pay, such as job experience, specific skills, and comparison to internal incumbents.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Additional company-provided benefits.