Senior Director, Quantitative Pharmacology

Otsuka Pharmaceutical Co., Ltd.

8d • $230,720 - $345,000

About The Position

As a leadership role in the Quantitative Pharmacology team within the Quantitative Translational Research (QTR) department, this position will oversee clinical pharmacology activities, contribute to the technical growth of the department, and support key success metrics for the Clinical Pharmacology team across all stages of clinical development. The role will also support the head of Quantitative Pharmacology in managing and growing the team, mentoring junior scientists, and overseeing project-level clinical pharmacology activities, including the development of SOPs/WPs and cross-functional working processes.

This role is responsible for overseeing clinical pharmacology deliverables for pre-IND, IND, Phase 1-3, Pharmacokinetics (PK), Pharmacokinetics-Pharmacodynamics (PK/PD) reports, and regulatory submissions. It also involves reviewing and approving Clinical Pharmacology reports and analyses. The Senior Director will oversee clinical pharmacology strategy and provide input into overall clinical development strategy and activities for all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development. They will serve as a Clinical Pharmacology Lead on early- and late-stage development teams, providing concise, data-driven, actionable plans and effectively communicating results and strategy. Additionally, this role will oversee interactions between the clinical pharmacology team and other QTR functions, such as non-clinical toxicology, DMPK, bioanalytical, and biomarker teams, for the design, execution, and reporting of clinical studies, particularly first-in-human and clinical pharmacology studies. The Senior Director will also review business development opportunities and make go/no-go recommendations on behalf of QTR, and collaborate with the QTR leadership team to set department strategy, growth, and cross-functional alignment.

Requirements

• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support.
• In-depth knowledge of early phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarker and bioanalytical assay in small molecule and monoclonal antibody (mAb) assets.
• Hands-on experience in PK and PK/PD data analysis and, Phoenix NLME, etc.
• Excellent working knowledge of phase I clinical operations, principle of drug development, multi-region regulatory requirements and PK/PD analysis.
• Great working knowledge of formulation development and clinical development.
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.
• Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong leadership experience related to clinical pharmacology.
• Strong organization skills.
• Strong communication skills.
• Flexibility to react rapidly to changing situations/environment.
• PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 12 years of experience in these areas.
• Experience in early-phase clinical protocol development is a plus.

Nice To Haves

• Experience in early-phase clinical protocol development is a plus.

Responsibilities

• Serve as clinical pharmacology lead on multiple cross-functional project teams; plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages of small or large molecule drugs.
• Review, approve and lead development of clinical pharmacology sections for regulatory filings, including annual reports, investigator’s brochure, IND/NDA/BLA applications and pediatrics development plans in compliance with relevant guidelines and standards.
• Work closely with pharmacometrics team, support model-based drug development (MIDD) strategies, and provide input to PK and PK/PD modeling analysis to support dose selection, efficacy and safety assessments.
• Work closely with Translational and biomarker team, support biomarker development and incorporation into early phase studies.
• Responsible for use of innovative methods of data analysis to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant).
• Review and approve clinical study design and protocols of healthy subject trials (including FIH SAD/MAD, DDI, rBA, mass-balance, HI/RI, TQT,...).
• Interact cross-functionally with other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC. Work with formulation, biomarker and bioanalytical team members on activities related to formulation development, assay development, sample management, Pharmacogenomics (PGx) and biomarker strategy development.
• Train and manage junior team members in Quantitative Pharmacology team. Mentor and develop clinical pharmacology talent as the pipeline and organization grow.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• tuition reimbursement
• student loan assistance
• a generous 401(k) match
• flexible time off
• paid holidays
• paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree