Associate Director, Clinical Scientist, Gastroenterology, US Medical Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity.

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.

About the role

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. You 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 role supports the conduct/execution of clinical studies, advancement of collaborative & investigator-initiated studies, and leads or contributes to the development of related study reports, abstracts, and manuscripts, particularly where related to efficacy & safety data and experience.

Responsibilities

• Develop and execute 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 partner 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).
• Act as a subject matter expert on previous and new data on approved immunology products, providing advice and input to the IET, commercial, V&E, and Medical Communication teams.
• Contribute to and/or lead 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.
• Build and manage effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.

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-world evidence study experience strongly preferred. Overall, the position requires at least 6 years of work experience in total.
• Gastroenterology or Immunology Therapeutic Area expertise is strongly preferred.
• Prior industry/medical affairs experience, including clinical study, registry, or real-world 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 with an 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.

Schedule

This position follows a hybrid schedule of three days in the office and two days remotely per week.