Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Objective:Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet.Our Data Sciences Institute (DSI) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists bring their expertise to our global program teams and reimagine our disciplines.As part of DSI, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project.Position Objectives:Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence.Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.Accountabilities:Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.Integrates pharmacokinetic, pharmacodynamic, efficacy, and safety data from multiple sources to optimize dosing for different populations across the development continuum.Drafts and executes clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions.Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches to inform internal decisions and external regulatory interactions.Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and is responsible for clinical pharmacology summary documents for regulatory submissions.Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.Maintains a high standard for good clinical practice, compliance, and ethics.Mentors junior staff to promote scientific excellence and individual achievement.Participates as a member of Business Development due diligence, when requested.Contributes to infrastructure initiatives and/or cross-functional best practice initiatives.Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums.Education & Competencies (Technical and Behavioral):Desired education qualifications and equivalencies and desired minimum years industry experience:Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.Desired technical skills:Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies.Formulates and executes clinical pharmacology plans including integration of MIDD principles.Advanced knowledge of the pharmaceutical industry, overall drug development process, and expertise in cross-functional interfaces.Advanced knowledge of regulatory guidance for industry applicable to clinical trials and regulatory submissions.Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data for dose selection and decision-making.Subject matter expertise in several clinical pharmacology areas.Scientific understanding of biological translation, drug development, and its integration into the clinical pharmacology/pharmacometrics strategy.Desired behavioral competencies:Independently works by delivering and prioritizing QCP activities across projects with minimal supervision.Effectively drives and influences project teams towards objectives.Focuses on priorities and delivers on commitments.Strong communication skills and ability to translate effectively across functional lines.Possess collaborative mindset, inspire teamwork, and build alliances across functions.Assess benefit/risk of options.Develop understanding of business beyond QCP/Pharmacometrics.Locations:Boston, MAWorker Type:EmployeeWorker Sub-Type:RegularTime Type:Full time

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