Job Information
J&J Family of Companies Manager, Clinical Pharmacology in Karnataka, India
Manager, Clinical Pharmacology - 2407022326W
Description
Manager Clinical Pharmacology
Who we are
At Kenvue (https://www.kenvue.com/) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
Role reports to: Head of Clinical Pharmacology
Location: Bangalore
What you will do
Provides clinical pharmacology support of innovation projects
Possesses and utilizes technical and scientific pharmacological experience to contribute towards pharmacokinetic/pharmacodynamic strategy and pharmacokinetic modeling for assigned need states
Serves as a team consultant for clinical pharmacology challenges/issues
Develops and delivers clinical pharmacology strategy for assigned Clinical Research projects to meet regulatory and claims needs
Key Responsibilities:
Works with R&D partners to support clinical pharmacology needs for existing and future products in EMEA, LATAM and other regions as applicable
Responsible for timely and appropriate execution of overall clinical pharmacology strategy for assigned New Product Development (NPD) and innovation projects
Utilizes technical and scientific pharmacological knowledge to shape and deliver the pharmacokinetic and pharmacodynamic strategy for assigned projects to meet regulatory and claims needs
Serves as a team consultant for clinical pharmacology challenges/issues
Leads clinical pharmacology interactions with regulatory agencies on clinical development programs
Advises on, Designs, executes or oversees pharmacokinetic/pharmacodynamic modeling for assigned need states
Responsible for timely and appropriate execution of overall clinical pharmacology strategy for assigned NPD and innovation projects
Serves as study director for assigned Clinical Pharmacology studies
Evaluates results of pharmacokinetic investigations and reports findings to senior management
Leads/Participates in preparation of internal study reports, and scientific presentations/publications
Leads or helps develop and author regulatory strategies and/or documents
As appropriate, participates on cross-functional teams for evaluation of innovation and new product ideas
Provides pharmacokinetic support to marketed product in response to safety and/or efficacy challenges
Responsible for the compliance of department, company and regulatory standards and procedures
Leads or contributes to operational improvement projects
Qualifications
What we are looking for
Education and Experience
PhD is preferred, however, an MS, M. Pharm or equivalent or PharmD with appropriate training in clinical pharmacology would be considered
Knowledge, Skills and Abilities:
Experience working in the Consumer Healthcare OTC or pharma environment will be a plus
Knowledge of key global regulatory frameworks including for selfcare products preferred
Excellent communication skills, including spoken and written English
Ability to work with cross functional teams
Ability to manage multiple projects
Understanding of Quality, Compliance, cGMP and regulatory requirements
Ability to prioritize request, propose effective cost/customer service alternatives and confidently address issues affecting the business
Ability to participate in due diligence on clinical pharmacology data for external innovation opportunities
Strong learning agility, drive and enthusiasm for innovation
Ability to influence without authority
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Asia Pacific-India-Karnataka-Bangalore
Job Function Pharmacokinetics
Req ID: 2407022326W