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Job Description
About the role:
At Takeda, we are guided by our purpose of Better Health for People, Brighter Future for the World and our commitment to patients, our people and the planet. As we continue to evolve our portfolio through acquisitions, partnerships, and divestitures, the ability to transition and integrate assets seamlessly is essential to delivering on our commitments to patients, regulators, and partners.
Our Data and Quantitative Sciences group (DQS) is a group of quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences, and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, 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.
How you will contribute:
- Serves as the global quantitative clinical pharmacology and pharmacometrics lead to manage multiple projects with a high level of technical and strategic independence.
- Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure, and best practice initiatives.
- Explores and excels in synergistic relationships with experts in clinical science, medical affairs, regulatory affairs, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
- Serves as an ambassador of Quantitative Clinical Pharmacology (QCP), Pharmacometrics and Data and Quantitative Sciences (DQS) 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 Clinical Pharmacology and pharmacometrics Lead on Global Program Teams and associated scientific and operational sub-teams.
- Be responsible for planning and executing clinical pharmacology studies to meet project needs, in close collaboration with key partner functions (e.g., clinical sciences, biostatistics, and programming).
- Represents Clinical Pharmacology and pharmacometrics in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
- Strategizes, oversees, and/or independently performs PK, PD, and pharmacometrics analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
- Maintains a high standard for good clinical practice, compliance, and ethics.
- Provides mentorship to junior staff, acts as a cross functional leader and team leader.
- Participates as a member of Business Development due diligence, when requested.
- Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
- Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline.
Minimum Requirements/Qualifications:
- Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD and pharmacometrics
- MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD and pharmacometrics
Desired technical skills:
- Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
- Extensive experience in late-state drug development, regulatory submissions (global submission experience preferred) and life-cycle management including pediatric drug development.
- Established pharmacometrician, recognized domain expert in a particular methodology or area e.g. safety and its application to drug development.
- Expert in use of some of the relevant softwares e.g. R, NonMem, Stan, SAS, Pheonix.
- Experience in leading and driving the scoping and implementation of MIDD within projects and at an asset/platform level.
- Advance knowledge and extensive hands-on experience in PK/PD data modeling and simulations.
- Familiar with regulatory guidance and submission process across different regionals.
- Experience in representing the QCP and pharmacometrics function in interactions with global or regional regulatory agencies at significant development milestones such as pre-submission, and pediatric development plan (PIP and PWR).
- Strong knowledge of allied fields critical for drug development, such as statistics, outcome research, Real World Data, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
- Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations, and influence TA strategies.
- Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
- Drives efficiency using innovative processes and methodologies.
- Knowledge and use of AI tools including Copilot
Desired competencies:
- Independently executes QCP and pharmacometrics deliverables
- Consistently delivers with high quality and efficiency.
- Elevates knowledge and enhances the capability of others.
- Communicates effectively and influences cross-functional teams.Inspires commitment and enables cross-function collaboration.
- Communicates success stories and shares learning across QCP.
- Focuses on priorities and delivers on commitments.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.
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Locations
Warsaw, Poland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time