Medical Director, Clinical Development

About the position

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

Responsibilities

• Leads execution of research programs for an area of clinical development to meet research objectives, support product development, and manage reports.
• Acts as the clinical functional head for providing active scientific contributions to a cross-department compound development team.
• 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.
• 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.
• Develops the strategy and content for scientific communications for assigned compound through close partnership with the compound global medical affairs leader.
• Serves as the clinical leader for product evaluation and develops the strategy and the content for regulatory documents.
• 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.
• 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.

Requirements

• 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.
• 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.
• 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.

Benefits

• Equal Opportunity Employer
• Inclusive interview process for applicants with disabilities