Senior Director, Quantitative Pharmacology
$230.72k - $345kOtsuka Pharmaceutical Co., Ltd
- # Senior Director, Quantitative PharmacologyApplylocations: Princeton, NJtime type: Full timeposted on: Posted Todayjob requisition id: R12763**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**- Travel 20-40%**Education and Related Experience** - 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.
- J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Director, Quantitative Pharmacology in Brooklyn, NY vacancy
$169.22k - $253k
Job Summary The role of this position is to provide clinical pharmacology input into all phases of both small and large molecule drug development across multiple therapeutic areas, such as CNS, Nephology, Infectious Disease, Immunology and so on. The responsibilities will...SuggestedContract workTemporary workLocal areaFlexible hours$11k
...like diving deep quickly. The Opportunity We're looking for a Senior Technical Product Manager who thrives on complexity, moves fast... ..., digging into the numbers, and forming hypotheses from quantitative data. A track record shipping in a fast-moving startup environment...SeniorRemote workFlexible hoursLoancrate Inc.
Brooklyn, NY4 days ago$209.6k - $313.38k
## Senior Director, Field Analytics & EnablmentApplylocations: Remotetime type: Full timeposted on: Posted Todayjob requisition id: R127... ...appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; and to think creatively...SeniorTemporary workLocal areaFlexible hours$200k - $235k
The Senior Director, Payments will lead Caesars Digital’s end-to-end payments business, owning the strategy, performance, economics, operations, and customer experience across deposits, withdrawals, reversals, refunds, and reconciliation. This leader will drive improvements...SeniorContract workTemporary workFlexible hours$117.6k - $160.73k
Job DescriptionStevens Institute of Technology seeks a Senior Director of Residence Life to oversee the Office of Residence Life within Student Affairs. Reporting to the Assistant Vice President for Student Affairs, the Senior Director provides leadership and vision for...SeniorFull timeFor contractorsSummer workSummer internshipWork at office- ...compliance Lead tax planning across entity rationalization, holding company structuring, and intercompany arrangements Advise senior leadership and the Board on tax implications of strategic decisions and business changes Own international tax operations across...SeniorPermanent employment
Jobtailor
Jersey City, NJ3 days ago $250k - $310k
...them as needed. Your recruiter will be able to clarify expectations and answer any questions you have. We're looking for a Senior Director, Tax & Treasury to lead the global tax and treasury functions for Collectors. This is a senior leadership role spanning domestic...SeniorPermanent employmentFull timeWork at officeLocal areaRemote workWorldwideFlexible hoursShift workCollectors Universe, Inc.
Jersey City, NJ2 days ago- ...Senior Director, Biostatistics – Immunology & Inflammation Regeneron is seeking a Senior Director, Biostatistics to drive our Immunology and Inflammation therapeutic area. Responsibilities Strategic and operational activities for the Biostatistics department. Develop and...Senior
Regeneron Pharmaceuticals
Brooklyn, NY2 days ago - ...Valid8 Financial, Inc. is seeking a Senior Director, Field Medical Affairs Team Lead to lead the strategic development and execution of the field medical organization for rese-cel in myositis and related autoimmune diseases. The role involves building and mentoring a high...SeniorRemote work
VALID8 Financial
Brooklyn, NY1 day ago - Volunteers of America National Services’ Senior CommUnity Care of Northern Kentucky PACE in Florence, KY is seeking a Therapy Recreation Specialist to lead the center’s therapeutic recreation activities and coordinate individual care plans. This role combines care planning...Senior
- Samsara is seeking a Senior Director, Compensation Partners to co-lead the Global Compensation team and shape the organization’s total rewards strategy. The role partners with senior leaders across Engineering, Product, Sales, and G&A to ensure competitive, equitable pay...SeniorRemote job
- HealthTrust is seeking a Senior Director of Pharmacy Contracting to lead national agreements and drive best-in-class pricing and terms for a premier GPO. The role emphasizes sourcing initiatives across high-spend categories, risk mitigation, and collaboration with clinicians...Senior
- Kennametal Inc. in Orwell, OH seeks a Manager, HR Service Delivery to educate and enable regional managers and staff to perform HR processes in a timely and effective manner. This role uses HR expertise to provide guidance and thought partnership to support key HR processes...Senior
Kennametal Stellite Inc.
Brooklyn, NY19 hours ago - The National Basketball Association (NBA) seeks a Senior Director, Broadcast Event & Studio Innovation Lead to shape the future of NBA and WNBA Local Media productions through innovation, strategic planning, and emerging technology. You will bridge production operations...SeniorLocal area
$250k - $300k
...Senior Director, Talent Acquisition As Altana enters its next chapter of growth, we're looking for a high-impact, mission-driven talent leader to lead our talent acquisition function and build a world-class organization capable of delivering on our most ambitious goals...SeniorFull timeTemporary workWork experience placementSummer workWork at officeRemote workRelocationFlexible hoursAltana Technologies
Brooklyn, NY4 days ago- Edwards Lifesciences in Irvine, CA seeks a Sr. Director of Program Management- Launch, Evidence, and Portfolio Capabilities to lead the BU PMO and drive global launch program management, evidence deliverables, and portfolio capabilities. You will elevate maturity across...Senior
- ...Stradit LLC in New Jersey seeks an experienced quantitative analyst to advance in-house fixed income risk models, leveraging Python, C++, and Java to build robust market risk tools. The role requires deep understanding of fixed income and market risk, with 5+ years in...Senior
Stradit
Jersey City, NJ19 hours ago - RingCentral is seeking a Senior Director, AI & SI Alliances to own and scale its AI technology and systems integrator partner ecosystem. This role involves driving executive relations, defining multi-year alliance strategies, and leading cross-functional teams to ensure...Senior
- Talener is seeking a seasoned Head of Product Management to lead their core Content Authoring Platform. This Senior Director role involves transforming a legacy ecosystem into a user-centric, AI-enabled platform, while mentoring a large product management team. The ideal...Senior2 days per week3 days per week
- GitLab Inc. is seeking a Senior Director, Revenue Analytics to lead a high-performing analytics team and own the strategic vision for data across sales, customer experience, and revenue operations. You will partner with executive leadership to translate data into strategic...SeniorRemote job
$247k - $302k
Madrigalpharma is seeking a Senior Director, Access & Reimbursement to oversee a team focusing on healthcare provider support for patient access. This role emphasizes leadership and strategic planning to enhance reimbursement processes for specialty products. Qualified...SeniorRemote job- The Global Senior Director Merchandising - Women's & Kids Apparel at The North Face leads the global strategy for Women's and Kids apparel, shaping long-range line planning, pricing architecture, and marketplace execution across DTC, Wholesale, and key accounts. The role...Senior
$135k - $225k
Job DescriptionWhat is the opportunity?RBC Capital Markets is seeking an experienced Java Developer with strong server-side expertise and low latency systems knowledge to join our Credit eTrading technology team.In this role, you will be instrumental in developing and maintaining...SeniorFull timeFlexible hours- Walmart in Hoboken, New Jersey is seeking a Senior Advertising Sales Manager to lead initiatives across Walmart Connect, advertising, CTV, programmatic, and retail. You will identify bottlenecks, build team knowledge, and drive performance with cross-functional partners...Senior
- Ultragenyx Pharmaceutical Inc. seeks a transformative Senior Director, Development Training & Enablement with a medical and scientific focus. This senior leader will shape the enterprise training strategy for Development, Medical Affairs, and Global Enablement, partnering...SeniorRemote work
- Ventra Health is seeking a Senior Director, Accounts Receivable to lead AR operations, EDIs, and denial management, aligning with the company's revenue cycle strategy. You will recruit, train, coach staff, drive policies, monitor metrics, and collaborate with offshore teams...Senior
- Otsuka Pharmaceutical Co., Ltd in the United States is seeking a Senior Director of Field Analytics & Enablement to lead a cross-functional analytics team. You will drive sub-national reporting, ad-hoc analysis, and reporting platform delivery for customer-facing teams...SeniorRemote job
- Sunrise Senior Living seeks an Executive Director to lead Lafayette Hill community operations, focusing on care, sales, financial performance and compliance. You will drive occupancy growth, revenue strategy and market positioning, while managing P&L and developing the...Senior
- Warner Music Group is seeking an Amazing Order-to-Cash (OTC) Leader to build a world-class OTC team in our regional center. Lead end-to-end OTC across multiple models and regions, ensuring accurate billing, collections, and revenue recognition in alignment with business...SeniorRemote job
- Covenant House International is seeking a Director of State and Local Advocacy to strengthen advocacy across United States sites, translating... ...related social determinants of health. The role reports to the Senior Vice President of Advocacy & Strategic Partnerships and serves...SeniorLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Quantitative Pharmacology. Be the first to apply!
Related searches
- director of corporate relations Brooklyn, NY
- director of stewardship Brooklyn, NY
- academic director Brooklyn, NY
- director of public policy Brooklyn, NY
- director of culinary Brooklyn, NY
- director of equity and inclusion Brooklyn, NY
- residence director Brooklyn, NY
- director of grants Brooklyn, NY
- political director Brooklyn, NY
- rehabilitation director Brooklyn, NY