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 the best talent for an
Associate Medical Director, US Medical Affairs, Dermatology located in
Horsham, PA.About ImmunologyOur 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
The Associate Medical Director US Medical Affairs - Dermatology will report to the Head (Senior Director), Dermatology, US Medical Affairs - Immunology, and be an important part of the Dermatology TA team, working closely with the other Dermatology 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 Dermatology within the Johnson & Johnson organization. The Associate Medical Director will be responsible for leading the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Dermatology. They will work with other team members and cross-functional partners to formulate and execute scientific strategy for marketed and pipeline products. They will also address medical questions and educational gaps that arise from field insights and from Dermatology HCPs. The Associate Medical Director will also lead or contribute to development of abstracts and manuscripts as either an author or reviewer.
This position resides in the Medical Affairs Dermatology Therapeutic Area (TA) Team which is responsible for developing, coordinating and executing the Therapeutic Area strategic plan for Medical Affairs. This therapeutic area strategic plan seeks to identify and address key stakeholders' knowledge gaps through data generation, data dissemination and education. The Medical Affairs Therapeutic Area (TA) teams are also responsible for designing and executing Phase IIIb/IV trials and any post-marketing requirements within the areas of Immunology's current or emerging assets in both adult and pediatric US indications. The Therapeutic Area (TA) team includes Medical Affairs Physicians, Research Scientists, and Operations members.
Key Responsibilities- Contributes to US Derm Medical Affairs strategy and will actively contribute to one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the IETs, including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing brand teams, as well as potentially Derm Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to support execution of the TA Strategy for establishing access as well as plans for evidence generation and dissemination plans.
- Contributes to and 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 Derm products/indications.
- Supports payer-related materials and data needs to scientifically support market access efforts.
- Contributes as a subject matter expert on analysis of key data in support of US Immunology for approved or planned therapies and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners)
- Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on efficacy, outcomes, and safety/adverse event analyses.
- May serves as the Study Responsible Physician (SRP) or Study Responsible Scientist (SRS) (depending on terminal degrees) for one or more studies, responsible for the development and execution of these Medical Affairs sponsored and supported clinical programs for company products in the TA, with mentorship and supervision. This will include study design, protocol development, regulatory communications, academic and community-based IBD HCP and investigator interactions, support of execution, and supervision of clinical studies of all types, including Phase IIIb/IV, registries, real world evidence, and investigator-initiated studies and collaborations supported by US Medical Affairs within the TA.
- Actively partners with individuals in TA team 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).
- Contributes to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the US FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
- Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.
Requirements- Bachelor's degree required / PharmD, PhD, MD/DO degree preferred; NP/PA considered
- At least 1.5 years of pharmaceutical industry experience preferred and/or at least 5 years post-graduate clinical medical practice which may include research experience (clinical studies, registries, epidemiology or health outcomes)
- Strong organizational, written, and verbal communication skills, including proficiency in effective and impactful oral presentations.
- Strong time management skills with the ability to be accountable for deliverables and timelines.
- 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.
- Energy and enthusiasm, leadership skills and potential, and the ability and desire to embrace building new expertise are essential.
- Proficiency in English is necessary.
Preferred:
- Experience in dermatology
- Experience with the planning and execution/writing of regulatory submissions, protocols, and/or scientific manuscripts.
- Experience with data analysis and review, and/or clinical study execution as either an investigator or a medical monitor or clinical scientist.
- Experience with the clinical use or clinical study of immunologic biologics and small molecules.
Other:
- Approximately 10% to 20% annual travel is generally required (primarily domestic, occasionally international).
Required Skills: Preferred Skills:Analytical Reasoning, Analytics Dashboards, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Data Analysis, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Strategies, Relationship Building, Report Writing, Strategic Thinking, Tactical Planning, Technical Credibility
