Associate Director, Quantitative Clinical Pharmacology Lead

Takeda Pharmaceutical Co.; Warszawa; Hybrid; PLN 150,000 - 210,000; Full time

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking a senior Global Clinical Pharmacology Lead to drive the clinical pharmacology strategy across multiple drug development programs.

You will provide strategic leadership, plan studies, and interact with clinical sciences, regulatory affairs, biostatistics, and partner functions to ensure robust PK/PD analyses. This hybrid role offers collaboration with global teams, mentorship of junior staff, and contributions to regulatory submissions and

Qualifications

• Pharm D. or PhD with 5+ years 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.

Responsibilities

• Lead global Clinical Pharmacology activities on multiple projects with strategic independence.
• Plan and execute clinical pharmacology studies with partner functions (clinical sciences, biostatistics, programming).
• Represent Clinical Pharmacology in regulatory meetings and prepare PK/PD summaries for submissions.
• Mentor junior staff and contribute to best-practice initiatives.

Education

Pharm D. or PhD

MS with 8+ years experience

Tools

Phoenix

NONMEM

R

Copilot

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:

Leads strategic, scientific, and operational aspects of multiple drug development 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 sciences, medical affairs, regulatory affairs, global outcomes/epidemiology, biostatistics, and other key data science disciplines.

Accountabilities:

• Provides scientific and strategic leadership as the Global Clinical Pharmacology Lead for multiple projects 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).


• Represent Clinical Pharmacology in meetings with global or regional regulatory agencies and be 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 DQS 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 related to the clinical pharmacology discipline.

Minimum Requirements/Qualifications:

• 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 with design, analysis, and reporting of clinical pharmacology studies.


• Experience in late-state drug development, regulatory submissions (global submission experience preferred) and life-cycle management including pediatric drug development.


• Knowledge of regulatory guidance and submission process across different regions.


• Proficient in analysis of PK and PD data using computer programs/software including Phoenix, NONMEM, and R.


• Knowledge and use of AI tools including Copilot

Desired competencies:

• Independently works by delivering and prioritizing QCP activities across projects with minimal supervision.


• Effectively drives and influences project teams towards objectives while enabling and making decisions.


• Focuses on priorities and delivers on commitments.


• Strong communication skills and ability to translate effectively across functional lines.


• Possess collaborative mindset, inspires teamwork, and is effective at building alliances across functions.


• Assess benefit/risk of options.


• Develop understanding of business beyond QCP/Pharmacometrics.

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.

Location:

Warsaw, Poland

Worker Type:

Employee, Regular Time, Full time

Other notes:

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

Equal opportunity statement:

Takeda is an equal opportunity employer.

Additional information:

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