Associate Director, Quantitative Clinical Pharmacology Lead

Posted Yesterday
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Warsaw, Warszawa, Mazowieckie, POL
Hybrid
Senior level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Leads global clinical pharmacology strategy and execution across multiple drug development projects. Plans and oversees clinical pharmacology studies, conducts PK/PD and pharmacometric analyses, supports regulatory submissions, interprets data, ensures compliance, mentors staff, contributes to business development and best-practice initiatives, and represents the discipline with regulators, scientific societies, and industry groups.
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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:
  • 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).
  • Represents 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.


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


#LI-Hybrid

#LI-AA1

LocationsWarsaw, Poland

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Skills Required

  • PharmD or PhD with at least 5 years of experience in a quantitative field and exposure to clinical pharmacology or PK/PD
  • MS with at least 8 years of experience in a quantitative field and exposure to clinical pharmacology or PK/PD
  • Advanced knowledge of clinical pharmacology study design, analysis, and reporting
  • Experience with late-stage drug development, regulatory submissions, and life-cycle management
  • Knowledge of regulatory guidance and submission processes across regions
  • Proficiency analyzing PK and PD data using Phoenix, NONMEM, and R
  • Knowledge and use of AI tools including Copilot
  • Strong communication, collaboration, decision-making, and cross-functional leadership skills

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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