Medical Director, Clinical Development, Interventional Oncology (INTO)

Johnson & Johnson • New Brunswick, PA

16h • Hybrid

About The Position

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. Johnson & Johnson Innovative Medicine is currently searching for the best talent for a Medical Director Clinical Development. This is a hybrid office-based role (≥ three days onsite) at any of the locations listed within the job posting. The Interventional Oncology (INTO) group, a cross-sector initiative at J&J, brings together the pharmaceutical and medical device expertise with the aim to meaningfully alter the course of cancer and improve survival. We conduct sophisticated clinical trials that involve the development of novel procedures and unique routes of administration for investigational cancer therapies. The Medical Director Clinical Development for Interventional Oncology will provide scientific, clinical, and operational direction for clinical programs in oncology. Responsibilities include contribution to the design of clinical programs and protocols; conduct of clinical trials guided by the highest standards of ethics and good clinical practices; development of clinical relationships with both internal and external partners; performing medical monitoring; and interactions with global regulatory agencies.

Requirements

• An MD is required
• A minimum of 2 years of oncology clinical research experience in clinical development within pharmaceutical industry or equivalent experience in academic or large regional hospitals is required.
• Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high-quality oncology clinical trials is required.
• Demonstrated ability to present scientific content to diverse audiences is required.
• Learning agility and ability to work across multiple sectors (pharm, medical device, and or consumer) is required.
• Fluent in written and spoken English with excellent communication skills is required.
• Ability to travel approximately 10% of the time is required.

Nice To Haves

• Advanced degree (PhD) is a plus.
• Experience in protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.

Responsibilities

• Drive execution of research programs for an area of clinical development to meet research objectives, support product development programs.
• Works in close partnership with the Clinical Leader, Compound Development Team (CDTL) and delivery unit, global regulatory affairs, clinical pharmacology, and the disease area leader to share information.
• Contributes to design and approval of clinical protocols.
• Perform medical monitoring of clinical trial data.
• Able to manage study start-up, and guides study team in study execution, data cleaning, medical review, database lock, managing health authority responses.
• Supports strategy and content development for scientific communications for assigned compound through close partnership with the compound global medical affairs leader.
• Works with senior clinical staff, establishes relationships with external stakeholders such as opinion leaders and regulators, and provides expertise in drug development (including experience with IND and NDA submissions).
• Works cross-sector in pharmaceutical and/or medical device spaces
• 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.
• Support design, approval & execution of clinical trials.
• Implementation and maintenance of high standards of research conduct
• Aid in writing high quality protocols and other clinical documents necessary for execution of clinical trials
• Perform medical monitoring tasks and safety data review to support development
• Site staff training to prospective & current investigators to assure high quality conduct of clinical protocols
• Represent INTO Clinical Development in discussions with cross functional trial teams and external vendors
• Maintain liaison with individuals and groups across all three sectors for purposes of information communication, technology transfer and collaborative work. This includes the Medical Devices sector, consumer sector & Janssen Oncology.
• Participation in strategic direction setting, especially with regards to clinical evidence generation for INTO including presentation at INTO Core Team meetings, pillar meetings, and in evaluating new business or scientific opportunities.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees