Manager, Quantitative Clinical Pharmacology Lead
Takeda · Bengaluru
Job Description
About the role:
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.
How you will contribute:
Position Objectives:
- Provides clinical pharmacology support at study or project level. 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 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 study level support to assigned projects with some level of supervision.
- Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.
- Contributes to clinical pharmacology content in regulatory submission documents such as briefing book, IB, IND, CTA, CTD Module 2 documents, CCDS, and product labeling.
- Oversees and/or independently performs PK, PD, or pharmacometrics analyses including the interpretation of PK/PD data in close partnership with DSI and external partners.
- Participates in activities supporting QCP strategies and mission.
- Maintains a high standard for good clinical practice, compliance, and ethics.
- Has scientific influence outside QCP and Takeda through presentations and publications
Job Description:
- Oversees and/or independently performs PK, PD, and pharmacometrics 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 related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.
Qualifications:
Desired education qualifications and equivalencies and desired minimum years industry experience:
- Pharm D. or PhD with 0-2 years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
- MS with 3+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
Desired technical skills:
- General knowledge in the application of PK/PD, Modelling and Simulation, and the use of clinical biomarkers and quantitative decision making.
- General understanding of clinical pharmacology study designs, common analysis methods and approaches e.g. NCA, Compartmental, PK-PD as well and basic statistics and working knowledge of common analysis software
- Basic knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated disciplines
- Basic knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA, EMA and others).
Desired behavioral competencies:
- Owns assigned tasks, identifies the need for and actively seeks input from others.
- Be eager to learn and have interest in scientific development
- Has excellent oral and written communications skills.
- Be able to introduce new ideas and improve existing approaches.
- Delivers on commitments