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:

Medical Affairs Group

Job Sub Function:

Medical Affairs – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America

Job Description:

About Immunology

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.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

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 Medical Director, Autoantibody Medical Affairs within our US Immunology Medical Affairs organization located in Horsham, PA.

As a part of US Medical Affairs Immunology, the Medical Director, Autoantibody Medical Affairs, will contribute to the strategic planning and execution of Phase IIIb & IV trials, post-marketing requirement studies, investigator initiated or collaborative studies, serving as a study responsible physician (SRP) for select medical affairs trials. The Medical Director, Autoantibody Medical Affairs will contribute/lead the advancement of protocol development, medical / data monitoring, study operations, data analysis / reporting, writing of study reports and publications, as applicable. Additionally, the Medical Director will partner with colleagues on real-world evidence, health economic and outcomes research, biostatistics, and work with commercial marketing colleagues through integrated evidence teams and other touchpoints to formulate and execute activities in support of the Autoantibody TA strategy across the asset, prioritizing key indications, i.e. neuromuscular, benign hematology.

You will be responsible for:

• Responsible for working with the Autoantibody Therapeutic Area Lead, as well as other individuals within Medical Affairs and other functional areas within J&J, as necessary, to facilitate research expanding the knowledge of JNJ products for autoimmune and alloimmune disease.

• Directly supervise and monitor trial conducts as well as work closely with other Medical Affairs medical monitor physicians to assure consistency of conduct across trials.

• Help develop and execute Medical Affairs sponsored and supported clinical programs by taking the lead in study design, protocol development, execution, and supervision of Phase IIIb/IV trials, registries, real-world evidence, collaborations and investigator-initiated studies in the dermatology therapeutic area.

• Collaborate with external investigators and thought leaders; serve as a liaison between company and clinical investigators and thought leaders, and develop credible relationships with thought leaders, medical directors, and key regulatory officials.

• Provide subject matter expertise and function as US medical representative with internal stakeholders across multiple functional areas including marketing and sales, health economics and outcomes research, MSLs, and medical information.

• Provide US medical input to R&D including input into design of R&D clinical trials and presentations and publications.

• Work closely with the Clinical Scientists, Program Management and GCDO to manage trial operations and provide program leadership; be prepared to quickly identify trial conduct and logistical problems and provide solutions to rectify the issues.

• Write as well as provide editorial comments for phase IIIb/IV clinical study reports, abstracts and manuscripts related to Janssen supported and sponsored studies.

Qualifications / Requirements:

• MD degree (or international equivalent) and US Board Certification are required; Neuromuscular training/experience desired

• At least 8-10 years total healthcare related experience (academic clinical research, clinical practice, and/or pharmaceutical industry) with at least 2 years of experience with clinical study, registry, or real-word evidence, prior commercial/medical launch experience is required

• Pharma industry experience is required; Medical Affairs experience is a strong asset

• Experience in clinical trial design (Phase IIIb & IV) and clinical data interpretation is required

• Prior experience in clinical research and exposure to industry partnered activities are strongly preferred

• Experience in scientific investigation into mechanisms of autoimmune/alloimmune disease preferred

• Excellent attention to detail and organization skills are vital for this position

• Experience interacting with health care professionals and other thought leaders is a strong asset

• Evidence of strong scientific writing skills and analytical thinking is essential

• Ability to work in a matrix environment is essential for success in this role

• Up 25% travel (primarily domestic & limited international) is required

• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week

Johnson & Johnson is 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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