Global Medical Head, Early Development, Interventional Oncology (INTO)

Johnson & Johnson Innovative Medicine; Cambridge (MA); Hybride; USD 232 000 - 401 000; Plein temps

Avantages offerts par ce poste

Long-term incentive program

401(k) plan with company match

Paid time off and holidays

Résumé du poste

Johnson & Johnson seeks an experienced oncology leader to drive strategy and execution across the INTO Early Development Portfolio and oversee global regulatory submissions. You will partner with clinical leaders, scientists and stakeholders to advance trials, balance budget and timelines, and interact with regulators and key opinion leaders.

You will mentor teams, influence cross-functional partners, and contribute to NDA/MAA preparations while championing Cullman Credo values and

Qualifications

• MD/DO or equivalent is required; an advanced degree (MS or PhD) is a plus.
• Minimum 8–10 years of oncology experience in pharma or academia.
• Board certified or eligible medical oncologist preferred; solid tumor oncology experience valued.

Responsabilités

• Define vision, strategy and accountability across the INTO Early Development Portfolio.
• Support clinical leaders and scientists with strategy, plans, trial cost and safety surveillance; lead regulatory submission plans.
• Collaborate with Data Management, Biostatistics, Regulatory, Engineering, Global Development, Quality and GMS for integrated execution.
• Ensure portfolio stays on time and on budget through life cycle phases including study start-up and data review.
• Evaluate scientific information to identify new research opportunities and support the INTO Discovery Forum.
• Oversee NDA/MAA development and responses to Health Authority questions and presentations.
• May review medical publications emerging from trials.
• Foster relationships with global Key Opinion Leaders and external stakeholders.
• Interact with medical consultants for IDMC/Investigator meetings and Advisory Boards.

Connaissances

Oncology leadership

Executive communication

Cross-functional collaboration

Regulatory strategy

Clinical trial oversight

IND/NDA submissions

Mentoring/people management

Strategic planning

Global/hs regulatory liaison

Study start-up leadership

Formation

MD, DO or equivalent

Advanced degree (MS/PhD) a plus

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

People Leader

All Job Posting Locations:

Cambridge, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Raritan, 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

Responsibilities:

• Define the vision, strategy and accountability across the INTO Early Development Portfolio.
• Provide expertise and support clinical leaders, SRPs and Clinical Scientists for strategy, plans for execution, product evaluation, complexity, trial cost, safety surveillance, and will be accountable for developing the strategy and plans for global regulatory submission and approval
• Works closely with functional partners (Data Management, Biostatistics, Regulatory, Engineering, Global Development, Quality, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.
• Accountability for portfolio to remain on time and on budget through life cycle: study start-up, and directs and guides study team in study enrollment, execution, data cleaning, medical review, database lock, managing health authority responses.
• Evaluates scientific information and new ideas to assist in identifying new research opportunities; Support the INTO Discovery Forum to advance pipeline
• Oversee with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing.
• May review/co-author medical publications emerging from clinical trial results.
• Acts as a liaison between the company and global Key Opinion Leaders by fostering strong relationships
• May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.
• 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:

• An MD, DO or equivalent is required. An advanced additional degree (MS or PhD) is a plus.
• A minimum of 8-10 years of experience in oncology within the pharmaceutical industry and/or academia is required.
• A trained medical Oncologist (Board certified or eligible or equivalent) is highly preferred. Consideration would be given for a non-medical oncologist with significant development experience in solid tumor oncology.
• Experience in early development oncology clinical research highly preferred
• Experience is solid tumor specifically highly preferred
• Three or more years of people management experience is required.
• A strong track record in a range of leadership roles that includes working with senior clinical staff, establishing credible relationships with external stakeholders such as opinion leaders and regulators, and demonstrating substantial experience in drug development (including experience with IND and NDA/BLA submissions)
• Past experience in managing study start-up, directing and guiding study team in study execution, data cleaning, medical review, database lock, managing health authority responses are also needed
• A strong commitment to oncology/hematology clinical research and the ability to work well within a matrix global team setting are 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 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 up to 25% of the time, both domestically and internationally.

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 and 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 email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

#LI - Hybrid

Required Skills:

Preferred Skills:

Clinical Research and Regulations, Clinical Trials, Collaboration, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change

The anticipated base pay range for this position is :

$232,000.00 - $401,350.00

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