Associate Director, QCP Lead

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Job Description:

Objective / Purpose :

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 and Quantitative Sciences group (DQS) 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 (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. 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.
• 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.
  
  

Education & Competencies (Technical and Behavioral) : :

• 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 behavioral 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.
  
  

Benefits:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are

Competitive Salary + Performance Annual Bonus

• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening, weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity, Equity, and Inclusion Programs
• No Meeting Days
• Reimbursements – Home Internet & Mobile Phone
• Employee Referral Program
• Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)
  
  

About ICC in Takeda:

• Takeda is leading a digital revolution. We're not just transforming our company; we're improving the lives of millions of patients who rely on our medicines every day.
• As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.
  
  

Locations:

IND - Bengaluru

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Locations:

IND - Bengaluru

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Locations:

IND - Bengaluru - Research and Development

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time