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Horsham Township, Pennsylvania, United States
Hybrid
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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 outstanding talent to join the Gastroenterology TA team within the US Immunology Medical Affairs organization as an Associate Director, Clinical Scientist, Gastroenterology located in Horsham, PA.
About J&J Innovative Medicine and 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:
The Associate Director, Clinical Scientist, Gastroenterology TA will be responsible for assisting in the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Gastroenterology therapeutic area and will partner with other Gastroenterology team members, as well as real-world evidence, real-world value and evidence, biostatistics, and commercial marketing personnel through integrated evidence teams (and other touchpoints) to formulate and execute scientific strategy on marketed products as well as address other medical questions and issues that arise from the field and experts in the Gastroenterology therapeutic area. The Associate Director, Clinical Scientist, Gastroenterology TA will also support the conduct/execution of clinical studies, advancement of collaborative & investigator-initiated studies and lead or contribute to development of related study reports, abstracts and manuscripts, particularly where related to efficacy & safety data and experience.
You will be responsible for:
Responsible for the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Gastroenterology TA.
Lead the day to day conduct of clinical studies of all types, including Phase IIIb/IV trials, registries, real-world evidence, collaborations, and investigator-initiated studies.
Actively partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (e.g. other MAF TAs, Biostats, R&D, Regulatory Affairs, QA and QC) to support Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
Actively contributes as a subject matter expert on previous and new data on approved immunology products, and provide advice and input to the IET, commercial, V&E and Medical Communication teams.
Contributes to and/or leads the development of study reports, abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on efficacy & safety analyses and experience.
Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.
Qualifications / Requirements:
BA/BS required. MA/MS/NP/PA/PharmD/PhD highly preferred, ideally with a focus on clinical research, public health, and/or epidemiology.
A minimum of 3 years of pharmaceutical industry experience with at least 2 years of clinical study, registry, or real-word evidence study experience strongly preferred. Overall, the position requires at least 6 years of work experience in total. A history of accountability for key deliverables with demonstration of their timely and successful execution is required.
Gastroenterology or Immunology Therapeutic Area expertise is strongly preferred
Prior industry/medical affairs experience, including clinical study, registry, or real-word evidence study support and execution is preferred. Prior R&D experience with responsibility and accountability for clinical study planning and execution is also a strong asset.
Experience with data analysis and review and study medical monitoring is preferred.
Strong organizational skills, written and verbal communication skills are required.
Excellent time management skills with the proven ability to plan and track deliverables and timelines are required.
Ability to work in a matrix environment with cross functional teams is mandatory.
Enthusiastic, energetic, self-starter, optimistic problem solving approach, strong leadership skills, and the ability and desire to embrace building subject matter expertise are essential.
Demonstrated commitment to learning emerging technologies, such as AI, through exploration, iteration, and applying new tools over time.
Excellent oral and written communication and presentation skills are required.
Up to 25% travel (primarily domestic & limited international) is required.
This position is 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Clinical Studies, Clinical Trial Planning, Clinical Trials, Gastroenterology, Immunology, Medical Affairs, Strategic Thinking