Medical Director, Autoantibody, Neuroimmunology- US Medical Affairs
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Job Location:
Horsham, PA - USA
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Medical Affairs GroupJob Sub Function:
Medical AffairsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Horsham Pennsylvania United States of AmericaJob Description:
We are searching for the best talent for aMedical Director Autoantibody Neuroimmunology - US Medical Affairs locatedin 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.
You will be responsible for:
- Work 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 and expanding the knowledge of J&J products for autoimmune diseases
- 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
- Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials registries real-world evidence and collaborations by leading study design protocol development analysis plan development and providing overall trial leadership (including execution monitoring supervision compliance and risk identification/ mitigation). This requires close partnership with a matrixed team inside and outside of Medical Affairs (e.g. Clinical Scientists Program Management Biostats Post-Approval Delivery Unit Regulatory Affairs Quality Medical Monitor external investigators/Key Opinion Leaders).
- Write as well as provide editorial comments for Phase IIIb/IV clinical study reports abstracts and manuscripts related to J&J supported and sponsored studies.
- Contribute to the preparation of regulatory submissions and interactions with Health Authorities (particularly the FDA) and help to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective efficient and scientifically rigorous methods.
- Provide US medical input to Research & Development (R&D) including input into design of R&D clinical trials presentations and publications.
- Contribute to US Autoantibody Medical Affairs strategy and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Autoantibody products/indications working cross-functionally with partners within the Autoantibody IET including Medical Science Liaison (MSL) team leaders Real World Value & Evidence Strategic Customer Group Marketing brand teams as well as potentially Autoantibody Disease Area Stronghold R&D Global Medical Affairs MSL and Global Commercial partners to promote and execute the Autoantibody TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans.
- Contribute to and potentially lead (as the Integrated Evidence Team Leader) the cross-functional team to develop and maintain a current strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline products/indications. Support payer-related materials and data needs to scientifically support market access efforts.
- 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 key regulatory officials medical societies and patient advocacy organizations.
- Review and evaluate Investigator-Initiated Study concepts champion prioritized concepts through appropriate review approval & funding and monitor study progress/milestones.
- 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.
Requirements
- MD DO PhD or PharmD degree is required
- 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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Required Experience:
Director
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
