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Job Function:
Medical Affairs Group
Job Sub Function:
Medical Affairs
Job Category:
Scientific/Technology
All Job Posting Locations:
Horsham, Pennsylvania, United States of America
Job Description:
We are searching for outstanding talent for Medical Director Rheumatology to join the Rheumatology therapeutic area team within the US Immunology Medical Affairs organization located in Horsham, PA.
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
Purpose:
This role will be a key member of the Medical Affairs Rheumatology Therapeutic Area (TA) Team and will report to the Head, Therapeutic Area Lead Rheumatology, US Medical Affairs- Immunology within the broader US Medical Affairs- Immunology organization. They will work closely with the other Rheumatology Medical Directors (and Associate Directors) as well as partners in US and Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members supporting Immunology and Rheumatology within the Johnson & Johnson organization to create, shape, influence and drive strategy for Rheumatology pipeline and approved products including evidence generation plans and subsequent execution, ensuring alignment with business objectives and regulatory standards. They will also lead and/or contribute to the development of related abstracts and manuscripts as either an author or reviewer.
The Medical Director Rheumatology will partner with other Rheumatology team members in the US and Global Medical Affairs Organization, as well as Real World Value and Evidence (RWV&E), Epidemiology, R&D, biostatistics, commercial Marketing brand, and field based (MSL, commercial, and payer-facing value and evidence) teams. They will shape the clinical and economic value narrative for one or more Rheumatology products/indications by participating in and/or leading their Integrated Evidence Team (IET), accountable for a strong scientific strategy and its execution through evidence generation efforts and their subsequent impactful presentation and dissemination approaches. May also be responsible for leading the strategic development and execution of US Medical Affairs-sponsored and supported clinical studies (Phase IIIb/IV trials, Post-Marketing Requirement studies, and investigator-initiated and collaborative studies) for company products in the Rheumatology TA.
You will be responsible for:
- Contribute to US Rheumatology Medical Affairs strategy, by leading one or more approved and pipeline Rheumatology products/indications, Integrated Evidence Teams (IETs), working cross-functionally with partners within the Rheumatology Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Field Value & Evidence, Strategic Customer Group, Marketing team brand leads, as well as potentially Rheumatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the Rheumatology TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans.
- Contributes to and potentially leads the cross-functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline Rheumatology products/indications. And supports payer-related materials and data needs to scientifically support market access efforts.
- May develop and execute (as Study Responsible Physician or Scientist [SRP/SRS]) Medical Affairs sponsored clinical study programs, including but not limited to Phase 3b/4 trials, registries, real-world evidence studies, investigator-initiated and/or collaborative studies in the Rheumatology TA. Contribute/lead study design, protocol development, clinical study report and publication development. Work closely with the matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight.
- Contribute to the preparation of regulatory submissions and interactions with Health Authorities/FDA and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
- Reviews and evaluates Investigator-Initiated Study (IIS) concepts, champion prioritized concepts through appropriate review, approval, & funding, and monitor study progress/milestones.
- Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) drugs and indications, partnering particularly with respective marketing brand teams as well as other commercial and IET partners, including RWVE, SCG, V&E Field, Medical Information & Scientific Communications partners.
- Actively partners with individuals in Rheumatology TA and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC) to create Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
- Support the fulfillment of medical information requests from field medical and field commercial teams. Support/ lead the development of medical education content for field medical team. Partner with medical communications and scientific exchange teams on content development, review, and approval.
- Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, including cumulative and/or directed safety experience.
- Identify new key opinion leaders (KOLs) and develop strong KOL collaborations on clinical trial development and medical affairs activities. Establish and foster relations with medical societies and patient advocacy organizations.
Qualifications / Requirements:
- Advanced degree (MD/DO, PhD, PharmD, DNP, etc.) is required.
- A minimum of 8 years of combined relevant experience in academic and/or clinical research, clinical practice, and/or pharmaceutical industry with include a history of accountability for key deliverables with demonstration of their timely and successful execution is required.
- Experience including commercial brand support, medical launch support experience, and clinical study, registry, or real-word evidence study support and execution are essential. Prior R&D experience with responsibility and accountability for clinical study planning and execution is an asset.
- Rheumatology or Immunology Therapeutic Area expertise is strongly preferred.
- Pharmaceutical industry experience is required
- Medical affairs experience is highly preferred
- Excellent analytical and strategic thinking aptitude, scientific writing proficiency, and strong organizational, written, and verbal communication skills, including proficiency in effective and impactful scientific oral presentations is essential.
- Excellent interpersonal and public speaking skills, and experience interacting with health care professionals and other thought leaders is essential
- Strong leadership, teaming, and collaboration skills and the ability to work in a matrix environment, collaborating effectively with many cross functional partners and succeed in participating in and leading cross functional teams to execute on deliverables is essential.
- Demonstrated commitment to learning emerging technologies, such as AI, through exploration, iteration, and applying new tools over time.
- Up to 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 & Johnson is committed to providing an interview process that is in line with our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Clinical Research, Collaboration, Data Dissemination, Data Generation, Immunology, Launch Excellence, Medical Affairs, Rheumatology, Stakeholder Collaboration, Strategic Thinking, Strategy Development
