Sr. Manager, Clinical Science, Cardiopulmonary

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Sr. Manager, Clinical Science, Cardiopulmonary to join our team in Raritan or Titusville, NJ or Spring House or Horsham, PA and Toronto, Canada.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-026027

Canada - Requisition Number: R-032706

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose: The Clinical Scientist (CS) is a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The CS provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The CS provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from a number of different disciplines. The CS may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

You will be responsible for:

• Supports preparation of clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and assists with completion of clinical study reports
• Assists Physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment and supports the interpretation and reporting of results
• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• Responsible for data review in conjunction with other clinical team members
• Assists Regulatory Affairs in the development of drug regulatory strategies
• Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
• Reviews medical literature and related new technologies
• May be asked to lead the execution of contracts
• May be asked to assess medical publications emerging from the team and its affiliates
• May be responsible, with appropriate colleagues, for review of Company advertising and promotion

Qualifications/Requirements:

Education:

• A minimum of a Bachelor's degree is required. An advanced degree (e.g., MS, RN, RD, PhD or PharmD) is preferred.

Skills/Experience:

• A minimum o