Medical Director/Senior Medical Director, Early Development Oncology

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.

About the role

Johnson & Johnson Innovative Medicine is recruiting for a Medical Director/Senior Medical Director-Clinical Research. They will be a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program, with a strong focus on breast cancer and related solid tumor indications.

Responsibilities

• Leads execution of research programs for an area of clinical development to meet research objectives, support product development, and manage reports, including programs in prostate cancer drug development across early-phase clinical trials.
• Acts as the clinical functional head for providing active scientific contributions to a cross-department compound development team, bringing deep disease-area expertise in oncology.
• Works in close partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader to share information, particularly as it relates to prostate/solid cancer development strategy and lifecycle planning.
• Acts as a liaison between the company and the clinical investigators, evaluates scientific information, and creates new ideas to assist in identifying new research opportunities in prostate cancer and relevant biomarker-defined populations.
• Develops the strategy and content for scientific communications for assigned compound through close partnership with the compound global medical affairs leader including oncology congresses and publications.
• Serves as the clinical leader for product evaluation and develops the strategy and the content for regulatory documents, with experience supporting prostate cancer indications and interactions with global health authorities.
• Works with senior clinical staff, establishes credible relationships with external stakeholders such as opinion leaders and regulators, and provides substantial expertise in drug development (including experience with IND and NDA submissions).
• Able to manage study start-up, and directs and guides study team in study execution, data cleaning, medical review, database lock, managing health authority responses, including prostate cancer-specific safety, efficacy, and benefit-risk considerations.
• May provide determination of pathology diagnosis and act as a signatory to primary and peer review pathology reports.
• Develops a goal-oriented clinical development team. Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• 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 is required; Advanced degree (PhD) is a plus.
• A minimum of 2 years of oncology clinical research experience in clinical development within the pharmaceutical industry or equivalent experience in academic or large regional hospital is required, with demonstrated experience in prostate cancer drug development strongly preferred.
• 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, including early-phase prostate cancer studies and translational endpoints.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word is required.
• Fluent in written and spoken English with excellent communication skills is required.

Skills

• Required Skills: Clinical Development, Early Clinical Development, Oncology Drug Development, Oncology Research
• Preferred Skills: Clinical Operations, Clinical Research and Regulations, Clinical Trials, Collaboration, Data Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Program Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management

Pay

The anticipated base pay range for this position is $199,000–$343,850 per year.

Benefits

• 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.
• Time Off Benefits (subject to terms of respective policies and date of hire):
  • Vacation: 120 hours per calendar year
  • Sick time: 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
  • 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

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits