Medical Director, Clinical Research

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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

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 Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. 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

The Medical Director will contribute to the development and oversee the execution of oncology clinical research studies, ensuring consistency and quality, across the assigned development program.  This person will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology. Together with the Clinical Leader, the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan.

ESSENTIAL FUNCTIONS: 
 

• Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.

• Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.

• Provide support for clinical study/studies within a development program including:

• Working closely with the colleague study responsible physicians and clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.

• Working in partnership with colleague study responsible physicians and clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies.

• Collaborate with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations.

• Participate in strategic study start-up planning in collaboration with GCO, C&G, and RTAEs including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations.

• Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents. 

• Work closely with Medical Writing to support protocol or protocol amendment completion.

• Work closely with Clinical Leader, Project Physician, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

• Work closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment. 

• Work closely with Quality Management & Quality Assurance to rev