Senior Director, Quantitative Pharmacology

Remote Full time

R12831

Job Summary As a leadership role in Quantitative Pharmacology team at Quantitative Translational Research (QTR) department, this role will oversee clinical Pharmacology activities, assist in department technical growth and contribute to key metrics of success of the Clinical Pharmacology team across all stages of clinical development. The role will also support the head of Quantitative Pharmacology, in managing/growing function team, mentoring/training junior scientists, and overseeing project-level clinical pharmacology activities, leading development of SOP/WP or cross-functional working process. Oversee clinical pharmacology deliverables related to pre-IND, IND, phase1-3, Pharmacokinetics (PK) , Pharmacokinetics-Pharmacodynamics (PK/PD) reports and regulatory submissions as well as review and approve Clinical Pharmacology reports and analyses. Oversee clinical pharmacology strategy and provide input into clinical development strategy and activities related all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Serve as a Clinical Pharmacology Lead in Early- and Late-stage development teams and provide concise, data driven actionable plans and efficiently communicate results and Clinical Pharmacology strategy to development teams. Oversee interactions of clinical pharmacology team with other QTR functions, including non-clinical toxicology, DMPK, bioanalytical, and biomarker teams, for design, execution and reporting of clinical studies, especially first-in-human study and clinical pharmacology studies. Review business development opportunities and make go/ no-go recommendations on behalf of QTR. Work with Quantitative Translational Research (QTR) leadership team to set department strategy, growth and cross functional alignment. Job Description 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 Qualifications/ Required Knowledge and Competencies 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. Skills 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. Travel 20% 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 Competencies 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. Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Company 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 other company provided benefits Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting View email address on click.appcast.io . Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond - under any circumstances, for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.