Medical Director, Study Responsible Physician - Late Development, Prostate

Johnson & Johnson Innovative Medicine; San Diego (CA); On-site; USD 199,000 - 344,000; Full time

Benefits offered by this job

401(k) plan

Vacation and sick time

Paid parental leave

Job summary

Johnson & Johnson Innovative Medicine in the United States seeks an experienced clinical development professional to advance oncology programs from early research to regulatory submission. You will lead project scientists, collaborate with data management, biostatistics, regulatory and GCO teams, and ensure rigorous medical monitoring across studies.

The role involves protocol development, site start-up planning, and contributing to regulatory submissions, with travel up to 20-30% annually.

Qualifications

• Advanced degree in Medicine (MD or equivalent).
• Board certified or board eligible in Uro-Oncology/Oncology preferred.
• Minimum 3+ years in a relevant urology/oncology clinical research position.

Responsibilities

• Lead project scientists with training, mentoring, and supervision.
• Coordinate with Data Management, Biostatistics, Regulatory, and other partners for flawless execution.
• Support clinical studies with medical monitoring, site issue responses, and SAE/death reviews.
• Develop high-quality study protocols with consistent processes across studies.
• Assist in NDA/MAA development and responses to Health Authorities.

Skills

Leadership

Cross-functional collaboration

Clinical research

Regulatory affairs

Education

MD or equivalent

Job description

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

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Clinical Development & Research - MD

Job Category

Scientific/Technology

All Job Posting Locations

La Jolla, California, United States of America, Los Angeles, California, 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.

Essential Functions

• Leads the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.
• Works closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, 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.
• Provides support for clinical study/studies within a development program including:
• Working closely with clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.
• Working in partnership with clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies.
• Collaborating with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations.
• Participating in strategic study start-up planning in collaboration with GCO and C&G including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations.
• Co-leading and overseeing clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
• Working closely with Medical Writing to support protocol or protocol amendment completion.
• Working closely with Clinical Leader, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
• Working closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment.
• Working closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans.
• Working closely with clinical scientists and data management to support medical review and data query resolution.
• Interacting with clinical investigators and Key Opinion Leaders as appropriate.
• Working with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct.
• Working with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports.
• Works 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.
• May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.

Qualifications

This position requires a minimum of an Advanced Degree in Medicine (i.e. M.D or equivalent). A trained (Board certified or Board eligible) Uro-Oncologist/Oncologist is strongly preferred. Applicable post-doctoral fellowship training is required. A minimum of 3 or more years of experience in a relevant urology/oncology clinical research position is required. Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important. Strong oral, written communication and presentation skills is required. Successful work experience in a matrix team environment with cross functional teams is required. The ability to use influencing skills is required. Travel required may be up to 20-30% annually (international, as well as domestic).

Required Skills

Business Savvy, Clinical Research and Regulations, Clinical Trials, Collaboration, 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

Preferred Skills

Business Savvy, Clinical Research and Regulations, Clinical Trials, Collaboration, 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.

Benefits

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