Medical Director, Early Development, Neuroscience

R&D        ·         Titusville / Cambridge        ·         Full time

•  Location: Titusville, New Jersey; Cambridge, Massachusetts
•  Category: R&D
•  Req ID: 2206071993W

Job Description

Janssen Research & Development, LLC is recruiting a Medical Director for the Early Development team in the Neuroscience Therapeutic Area located in Titusville, NJ or Cambridge, MA. In this role, the ideal candidate will apply their knowledge of neurological disorders and expertise in clinical trials to advance novel compounds through the clinical development pipeline.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities:

• Design and implement early clinical development strategies for new drug candidates: Lead interdisciplinary clinical study teams and collaboratively conduct Phase 0, 1 and 2a trials to evaluate proof-of-concept for new drug candidates. Lead the preparation of clinical development plans and clinical study protocols, and contribute to Investigator Brochures, study reports, and Ethics Committee and regulatory agency submissions.
• Medical monitoring/reporting and working with company safety officers to ensure adherence to regulatory requirements; review and evaluate preclinical and clinical study safety, pharmacokinetic, pharmacodynamic, and efficacy data. Responsible for the medical management and safety aspects of the design, conduct, monitoring, and analysis of clinical trials
• Collaborate with discovery and biomarker teams; contribute to the integration of biomarkers in clinical studies to facilitate early drug evaluations
• Interact with clinical sites and investigators regarding study implementation
• Influence strategic decisions regarding therapeutic indications for new drug candidates from Phase 0 and Phase1 to Phase 2a proof of concept (POC)
• Contribute to in-licensing evaluations and due-diligence activities

Qualifications

Education:

• Medical Degree (MD or equivalent) or MD/PhD required.
• Completion of post-graduate training/residency in Neurology required.
• Board Certified/Board Eligible preferred.

Experience and Skills:

Required:

• 5+ years of pharmaceutical development experience OR 5+ years of experience with clinical trials is required.
• Expert knowledge and experience in neurological disorders is required.
• Experience working as a neurologist is required.
• Expert knowledge of and experience in use of biomarkers for subject phenotyping, monitoring disease progression in neurological disorders is required
• Basic knowledge and understanding of clinical pharmacology is required
• Good knowledge of quantitative methods including statistics is required
• Experience with writing scientific reports and manuscripts is required
• Ability to critically evaluate data, literature, and presentations is required
• Good understanding of early drug development and clinical trial processes in the pharmaceutical industry is required
• Knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials is required

Other:

• Experience in clinical neurophysiology/EEG is strongly preferred.
• Ability to lead cross-functional teams optimally is required
• Proficiency in English (written and spoken); excellent verbal and written communication skills are required
• Up to 25% domestic and international travel is required.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location: United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations: North America-United States-Massachusetts-Cambridge
Organization: Janssen Research & Development, LLC (6084)
Job Function: R&D
Requisition ID: 2206071993W

Please click here to apply.