Clinical Director Jobs

About The Position

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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• inclusive work environment
• respect the diversity and dignity of our employees
• recognize their merit