Clinical Pharmacology Team Lead

5 days ago

Bengaluru, Karnataka, India Kenvue Full time

About the Role

We are seeking a highly skilled Manager, Clinical Pharmacology to join our team at Kenvue. As a key member of our Clinical Pharmacology team, you will be responsible for providing clinical pharmacology support for innovation projects, developing and delivering clinical pharmacology strategies for assigned Clinical Research projects, and serving as a team consultant for clinical pharmacology challenges/issues.

Key Responsibilities

  1. Works with R&D partners to support clinical pharmacology needs for existing and future products in EMEA, LATAM, and other regions as applicable.
  2. Responsible for timely and appropriate execution of overall clinical pharmacology strategy for assigned New Product Development (NPD) and innovation projects.
  3. Utilizes technical and scientific pharmacological knowledge to shape and deliver the pharmacokinetic and pharmacodynamic strategy for assigned projects to meet regulatory and claims needs.
  4. Serves as a team consultant for clinical pharmacology challenges/issues.
  5. Leads clinical pharmacology interactions with regulatory agencies on clinical development programs.
  6. Advises on, designs, executes or oversees pharmacokinetic/pharmacodynamic modeling for assigned need states.
  7. Responsible for timely and appropriate execution of overall clinical pharmacology strategy for assigned NPD and innovation projects.
  8. Serves as study director for assigned Clinical Pharmacology studies.
  9. Evaluates results of pharmacokinetic investigations and reports findings to senior management.
  10. Leads/participates in preparation of internal study reports, and scientific presentations/publications.
  11. Leads or helps develop and author regulatory strategies and/or documents.
  12. Participates on cross-functional teams for evaluation of innovation and new product ideas.
  13. Provides pharmacokinetic support to marketed product in response to safety and/or efficacy challenges.
  14. Responsible for the compliance of department, company, and regulatory standards and procedures.
  15. Leads or contributes to operational improvement projects.

Requirements

  1. PhD is preferred; however, an MS, M. Pharm or equivalent or PharmD with appropriate training in clinical pharmacology would be considered.
  2. Experience working in the Consumer Healthcare OTC or pharma environment is a plus.
  3. Knowledge of key global regulatory frameworks including for self-care products is preferred.
  4. Excellent communication skills, including spoken and written English.
  5. Ability to work with cross-functional teams.
  6. Ability to manage multiple projects.
  7. Understanding of Quality, Compliance, cGMP and regulatory requirements.
  8. Ability to prioritize requests, propose effective cost/customer service alternatives, and confidently address issues affecting the business.
  9. Ability to participate in due diligence on clinical pharmacology data for external innovation opportunities.
  10. Strong learning agility, drive, and enthusiasm for innovation.
  11. Ability to influence without authority.

About Kenvue

We are a global company built on over a century of heritage and rooted in science. Our iconic brands include NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S, and BAND-AID. At Kenvue, science is our passion, and care is our talent. We put people first, care fiercely, earn trust with science, and solve with courage. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the best products to our customers.

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