Medical Director, Project Responsible Physician - Neuropsychiatry

Clinical Development And Research – MD

The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a full development stage compound program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings.

Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Essential functions include:

• Responsible for medical monitoring/reporting and company safety officer activities
• Works on clinical development plans, trial protocols and takes ownership of clinical study reports
• Evaluates adverse events (pre and post-marketing) for relationship to treatment
• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
• May act as a medical contact at the company for health authorities concerning clinical/medical issues
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• Close interactions with Project Scientists and Physicians across programs

Other responsibilities/detailed duties include:

• Assists Regulatory Affairs in the development of drug regulatory strategies
• Helps explore and evaluate new product ideas to assist in identifying new market opportunities
• Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
• Reviews medical literature and related new technologies
• May be asked to assess medical publications emerging from the Team and its affiliates
• May be responsible, with appropriate colleagues, for review of Company advertising and promotional materials.

Education: MD (or equivalent) in relevant area with appropriate post-doctoral training and certification. Training in psychiatry or neurology preferred.

Required technical knowledge and skills:

• Fluent in written and spoken English
• Working knowledge of the use of Microsoft suite of software products including Excel and Word
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
• Exceptional analytical and critical thinking skills, with the ability to translate complex data (scientific/financial/operational) into actionable insights for strategic decision making.
• Exceptional communication and presentation skills, with the ability to clearly articulate complex ideas to cross functional teams and stakeholders

Required skills: Clinical Research, Neurology, Neuroscience

Preferred skills: Business Alignment, Clinical Data Management, Clinical Evaluations, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Industry Analysis, Leadership, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Stakeholder Engagement, Strategic Change, Study Management

The anticipated base pay range for this position is: $199,000.00 - $343,850.00

Additional description for pay transparency: 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. 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 period 10 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: - https://www.careers.jnj.com/employee-benefits