Medical Director, Clinical Development, Interventional Oncology (INTO)

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•$199,000 - $343,850•Hybrid

About The Position

At Johnson & Johnson, health is everything, driven by innovation in Innovative Medicine and MedTech to prevent, treat, and cure complex diseases. The Oncology team is dedicated to eliminating cancer through new pathways and modalities. This role is for a Medical Director Clinical Development within Johnson & Johnson Innovative Medicine, operating in a hybrid office-based model (requiring at least three days onsite) at specified locations. The Interventional Oncology (INTO) group is a cross-sector initiative combining pharmaceutical and medical device expertise to significantly alter the course of cancer and improve survival. This involves conducting sophisticated clinical trials for novel procedures and unique routes of administration for investigational cancer therapies. The Medical Director will provide scientific, clinical, and operational direction for oncology clinical programs, including contributing to program and protocol design, conducting clinical trials with high ethical standards, developing clinical relationships, performing medical monitoring, and interacting 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. Travel includes internal meetings in posted locations as well as travel to investigative sites to work with actual and potential study sites and to National and/or International scientific congresses

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
Business Savvy
Clinical Research and Regulations
Clinical Trials
Collaborating
Consulting
Data Management and Informatics
Design Mindset
Drug Discovery Development
Industry Analysis
Innovation
Market Research
Regulatory Affairs Management
Research Ethics
Scientific Evaluation
Scientific Research
Stakeholder Management
Strategic Analysis

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

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
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