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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function: **
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function: **
Clinical Development & Research – MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Boston, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, 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
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.
**Key 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.
Required Qualifications
- An MD is required; Advanced degree (PhD) is a plus.
- 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.
- Experience in protocol development, medical review, oversight of study conduct, running trials, data quality and safety are strongly preferred.
- 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.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
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
The anticipated base pay range for this position is :
$199,000.00 - $343,850.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits