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 to join the Gastroenterology TA team within the US Immunology Medical Affairs organization as an
Associate Director, Clinical Scientist, Gastroenterology located in
Horsham, PA.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.
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Required Skills: Preferred Skills:Clinical Studies, Clinical Trial Planning, Clinical Trials, Gastroenterology, Immunology, Medical Affairs, Strategic Thinking
