Johnson & Johnson is currently seeking a Medical Director, Clinical Development to join our Interventional Oncology team in North America (Spring House or Horsham, PA; Titusville, NJ; or Boston MA; Raritan, NJ). Remote based positions within the USA may be considered on a case-by-case basis and if approved by the company.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
One of our key initiatives is Interventional Oncology, a cross-sector effort charged by the Executive Committee of Johnson & Johnson with altering the course of solid tumors by combining novel intratumoral drugs and/or energy modalities with systemic agents. We conduct sophisticated global clinical trials that involve the development of novel procedures and unique routes of administration for investigational cancer therapies.
The Medical Director, Clinical Development will actively participate and lead aspects of the development, oversight, and execution of Ph I-IV clinical trials working within the Clinical Development team (Clinical Leaders, and Clinical Project Scientists). The position reports to a Senior Medical Director Clinical Development. The ideal candidate will have Medical Oncology experience, specifically in the management of Head and Neck cancer.
This role will be focused on execution of clinical research studies that are part of a global compound development program. This role will work in collaboration with multiple functional disciplines, including Clinical Operations, Data Management, Statistics, Regulatory, and Safety to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical trials.
Essential Functions:
1. As part of the Clinical Development team, works in close partnership with Development Team Leader (DTL), Biostatistics, Data Science, Clinical Operations, global regulatory affairs, clinical pharmacology, and other cross functional stakeholders to guide clinical development.
2. Drive comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, data query review and detailed, real-time review of serious adverse events in collaboration with safety.
3. Acts as a liaison between the company and clinical investigators and Key Opinion Leaders to establish strong relationship to promote clinical trial enrollment and generation of high quality data
4. Supports development of strategy and content for scientific communications for assigned compound through close partnership with the compound global medical affairs leader.
5. Support development of high quality study protocols including use of consistent processes/standards across studies.
6. Work closely with Medical Writing to support protocol or protocol amendment completion.
7. Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
8. Work closely with Regulatory and Clinical Operations to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
9. Partner directly with Clinical Operations to track study recruitment and implement action plans to address early impediments to study enrollment.
10. Work with the Clinical Leader, Data Management, and Statistics on analysis of study results and completion of study reports.
11. Work with medical consultants to support IDMC, Investigator meetings, and Advisory Boards
12. Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.