Director, Study Responsible Physician - Mivexian

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 – MD

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

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 

POSITION SUMMARY:

The Director, Study Responsible Physician (SRP) is responsible for development and execution of medical and scientific strategy for a selected clinical trial(s) in the development program for Milvexian and operational implementation, delivered through effective communication with Cross-Functional Trial Team (CFTT).  The SRP provide support to a study senior physician, clinical leader (CL) to deliver a trial(s) in a timely and cost-effective manner or program wide activities and is responsible for site interactions in partnership with the clinical project scientist (CPS) for medical questions and education (including safety management guidelines), protocol development, execution, preparation and ownership of clinical study reports and for the preparation and approval of essential documents for regulatory filings. Performs medical safety data review, including evaluation of adverse events and eligibility of participants for assigned studies. May also be responsible for program wide activities such as interactions with IDMC, clinical events committee. May leads or co-leads CFTT, provides leadership via matrix interactions also includes individuals from project management, operations, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations. The SRP is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.

ESSENTIAL FUNCTIONS:

• Supervision, and development of junior medical staff assuring diversity of candidates

• Supports development of clinical development plans and ownership for the design of clinical trials and for the content of clinical study reports

• Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions

• Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment

• Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting

• May act as medical contact at company for worldwide health authorities concerning clinical/medical issues

• Assists Regulatory Affairs in the development of drug/device regulatory strategies

• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees

• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities

• Supports general activities involving product evaluation, labeling and surveillance

• May support early clinical development and discovery activities involving product potential and development for registration

• Participates on evaluation of new product ideas, implement franchise business strategies, etc.

• Responsible for assessment of me