Senior Director, Quantitative Pharmacology
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 of 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 function team, mentoring and training junior scientists, and overseeing project-level clinical pharmacology activities, including the development of SOPs/WPs or cross-functional working processes. Key responsibilities include overseeing clinical pharmacology deliverables for pre-IND, IND, Phase 1-3, Pharmacokinetics (PK), Pharmacokinetics-Pharmacodynamics (PK/PD) reports, and regulatory submissions. This includes reviewing and approving Clinical Pharmacology reports and analyses. The role involves overseeing clinical pharmacology strategy and providing input into clinical development strategy and activities for all phases of drug development, including dose finding, dose optimization, exposure-response, and pediatric development. The Senior Director 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, the role will oversee interactions with other QTR functions (non-clinical toxicology, DMPK, bioanalytical, biomarker teams) for the design, execution, and reporting of clinical studies, particularly first-in-human and clinical pharmacology studies. The position also involves reviewing business development opportunities and making go/no-go recommendations on behalf of QTR, and collaborating with the QTR leadership team to set department strategy, growth, and cross-functional alignment.
Requirements
- 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.
- 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 to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- 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.
Nice To Haves
- Experience in early-phase clinical protocol development
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
