Medical Director/Senior Medical Director, Early Development Oncology

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).
• Manages 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 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.