Program Manager (m/f/d) Scientific & Clinical Affairs

at  Johnson Johnson

Johnson & Johnson is currently seeking a Program Manager (m/f/d) Scientific & Clinical Affairs to join our Abiomed Team located in Aachen Germany.
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. Learn more at https://www.jnj.com/ .
As the Program Manager (m/f/d) Scientific & Clinical Affairs, the individual in this role plays a crucial part in overseeing, fostering growth, and facilitating the development of Clinical Project Managers. Collaborating closely with the Medical Affairs EMEA & APAC team, they are instrumental in the management of research activities, ensuring the effective planning, start-up, maintenance, and closeout of clinical research studies.

Primary Duties and Responsibilities:

• Lead the hiring, training, and retention efforts for Clinical Project Managers and other research staff
• Conduct periodic and year-end performance reviews, proactively identify and address areas of concern, and provide development opportunities
• Be accountable for the development of direct reports through performance reviews, mentoring, coaching, and goal-setting
• Provide hands-on leadership to integrate all project team activities, managing clinical research metrics, and optimizing resources.
• Contribute strategic input, manage and execute research projects including timelines, budgets, financial information, and data flow.
• Effectively communicate and interact with Key Opinion Leaders
• Assist Director, Scientific & Clinical Affairs in the preparation and execution of sound research development strategies.
• Interface with Finance, Accounting, Quality and Regulatory
• Maintain an understanding of current clinical regulations, industry practices, and engage in relevant professional associations or societies.
• Support Quality Assurance to ensure CAPAs are adequately developed, reviewed, and implemented.

JOB QUALIFICATIONS:

• BS degree in Science, Engineering, or a related medical/scientific field; MS or graduate degree preferred.
• 8+ years of clinical research experience with a CRO or Medical Device Company
• Strong EU regulatory knowledge, including experience with Ethics Committee and Competent Authority submissions in various countries, and a deep understanding of Good Clinical Practices (GCPs)
• Exceptional organizational skills, ability to manage competing priorities, strong reasoning, and problem-solving ability
• Excellent communication (written and verbal) and presentation skills in both German and English
• Proficient with MS Office Suite (Excel, Word, and PowerPoint) and Project Planning Software (e.g., Wrike, MS Project)
• Ability to be independent

• Lead the hiring, training, and retention efforts for Clinical Project Managers and other research staff
• Conduct periodic and year-end performance reviews, proactively identify and address areas of concern, and provide development opportunities
• Be accountable for the development of direct reports through performance reviews, mentoring, coaching, and goal-setting
• Provide hands-on leadership to integrate all project team activities, managing clinical research metrics, and optimizing resources.
• Contribute strategic input, manage and execute research projects including timelines, budgets, financial information, and data flow.
• Effectively communicate and interact with Key Opinion Leaders
• Assist Director, Scientific & Clinical Affairs in the preparation and execution of sound research development strategies.
• Interface with Finance, Accounting, Quality and Regulatory
• Maintain an understanding of current clinical regulations, industry practices, and engage in relevant professional associations or societies.
• Support Quality Assurance to ensure CAPAs are adequately developed, reviewed, and implemented