Manager, Clinical Pharmacology

4 weeks ago


Bengaluru, Karnataka, India Kenvue Full time
Manager, Clinical Pharmacology-2407022326W

Description

Manager Clinical Pharmacology

Who we are

At , 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, . 

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

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