Johnson & Johnson Careers
Medical Director, US Scientific Affairs
Requisition ID: 5904190530
Janssen Scientific Affairs, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Medical Director, US Scientific Affairs, to be located in Titusville, NJ.
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 Scientific Affairs, LLC is part of the Janssen Pharmaceutical Companies.
The Medical Director is responsible for the design, conduct, analysis and reporting of clinical trials and research related activities within US Medical Affairs Neuroscience. Responsibilities include partnership with clinical operations personnel and frequent interactions with internal and external business partners including regulatory, brand marketing, Real World Value & Evidence (RW V&E), Janssen Research & Development (JRD), Global Medical Affairs, epidemiology, clinical investigators and key external experts. The Director will have responsibility for various activities related to a pharmacologic molecule such as pharmacovigilance, medically important results assessments (MIRA) evaluations, promotional review committee assignment, label revisions, speaker and sales representative training, and other similar activities. The Director will support training to meet current and future business needs of the franchise, as well as contribute to creating a work environment that engenders the company's commitment to equal employment opportunity and the value of a diverse work force.
Provide oversight and direction as required for the design, planning, conduct and analysis of clinical trials; Specific activities include identifying potential opportunities of interest, as well as study design, protocol development, fulfilling the role of medical monitor and ensuring study conduct is in compliance with GCPs and applicable SOPs, directing appropriate analyses and preparing final reports, and partnering with regulatory affairs as required for filing of FDA documents. Must demonstrate effectiveness and productivity working in cross-functional teams either as a matrix leader or contributor.
Provides clinical and scientific leadership through interaction with internal and external experts, partners with colleagues across Medical Affairs, RW V&E, JRD, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, J&J Corporate Communications, and J&J Legal; Frequently interact with field based Medical Affairs personnel, participates in promotional copy review and supports medical information services; Responsible for development and review of regulatory documents for FDA submission. The Director may be expected to provide a leadership role in safety monitoring activities.
Participates in the development of scientific strategy and communication plans; Reviews manuscripts for scientific accuracy and fair balance. Participates in the process of post-hoc exploratory analyses and communication of the results. Participates in the decision to fund investigator initiated studies and provides clinical support as required. Responsible for managing CROs, external agencies and contract personnel as required.
Develop and fosters relationships with thought leaders, scientific societies and advocacy groups. Remains current with and contributes to the scientific literature within field of focus.
Contribute to L&A activities as called upon and identifies new compound opportunities. Participates in J&J initiatives relevant to therapeutic responsibilities.
Key Working Relationships: Internal - Medical Affairs & Scientific Field Leadership, Home office leadership including people managers and Therapeutic Area Leaders (TALS), other TA and JSA training, learning and development leaders. External - Collaboration with external vendors and interactions with external experts. May interact with advocacy groups and professional organizations.
- Support early pipeline products as assigned
- Indirect Reports: 1-2
- 15 – 25% domestic travel
10+ years professional experience obtained in clinical practice, industry or academia, at least 3 of which must be in the pharmaceutical industry
Preferred Minimum Education: MD or DO or the equivalent degree
Other: Psychiatric Nurse Practitioner or PharmD
- Preferred Area of Study: Psychiatry
Demonstrated success leading a clinical/scientific cross functional team preferred
Experience with oversight of clinical studies preferred
Experience in relevant therapeutic area and related healthcare environment (e.g. neuroscience) required
Board certification and clinical experience preferred
Publication planning and execution experience preferred
- KOL engagement experience preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Titusville-
Janssen Scientific Affairs, LLC (6120)