Medical Director, Clinical Development (Interventional Oncology)

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.

Qualifications

Education and Experience:

• M.D. with formal training in Oncology or Hematology is required.
• Experience in solid tumors and specifically with Head and Neck or Lung Cancer is preferred
• 3 or more years' experience in clinical research within the pharmaceutical industry or academia is required.

Required Technical Knowledge and Skills:

• Ability to engage and collaborate with clinical trial sites across multi-disciplinary teams.
• High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards
• Successful work experience in a matrix team environment with global cross functional teams
• Fluent in written and spoken English with excellent oral and written communication skills
• Working knowledge of the use of Microsoft suite of software products
• Knowledge of Good Clinical Practices ICH/GCP, drug development process, and regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality
• Ability to travel approximately 20% domestic/international travel is required

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is $194,000 to $334,650. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on February 28, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.