Medical Director, Study Responsible Physician Late Development, Prostate

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

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 Clinical Research Oncology is a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program. The Director supports the Clinical Leader and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications. He/She provides mentoring and support to the clinical study team and works closely with the clinical project scientists and Clinical Leader in Late Development in collaboration with other functional disciplines including GCO Data Management Statistics Regulatory QMMC and GMS to ensure flawless and integrated execution of study start-up planning oversight and reporting of clinical studies in Oncology. Together with the Clinical Leader the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan.

The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards. The successful candidate must be equally comfortable among the team to which he/she is assigned and in the global environment in which the company operates.

TheDirector Clinical Research Oncology holds overall responsibility for flawless execution of the assigned study/studies leading the study team in a matrix organization. He/She assists in the preparation of protocol writing for and operational execution of clinical studies. He/She leads the medical review of critical data collected throughout the study. He/She participates in the interpretation and reporting of the results of the research including submission to health authorities. He/She evaluates scientific information and new ideas to assist in identifying new research opportunities. TheDirector supports medical affairs activities involving product evaluation labeling and surveillance. He/She will assess external clinical research proposals involving company products and manuscripts that are being prepared for publication. TheDirector acts as a liaison between the company and clinical investigators. TheDirector develops in concert with senior clinical staff credible relationships with opinion leaders and clinical research staff globally.

The Director Clinical Research Oncology reports directly to a Clinical Leader for the product to which he/she is assigned.

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:

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 :

$199000.00 - $343850.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Director