Associate Medical Director

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

4d • $137,000 - $235,750 • Hybrid

About The Position

The Associate Medical Director acts, in collaboration with CAPLYTA Medical Affairs leadership, to connect therapeutic strategy with the clinical, scientific, and operational implementation of U.S.-focused company-sponsored or investigator-initiated studies supporting CAPLYTA. This position reports to the Medical Director, Evidence Generation Lead. The Associate Medical Director supports medical strategy, evidence generation, publication planning, scientific communications, and research-related activities to ensure timely, compliant, and scientifically rigorous execution. The role also participates in protocol development, interpretation of results, and preparation of internal and external scientific communications.

Requirements

• BA/BS in Science or Healthcare required.
• Minimum of 5 years of experience within the pharmaceutical industry is required, with experience managing Phase IIIb–IV clinical trial programs and other research activities.
• Technical proficiency and strong problem-solving skills.
• Strong leadership, interpersonal, partnership, and oral/written communication skills.
• Ability to operate in a matrixed environment and experience with cross-functional alliances.
• Ability to think creatively, critically, and proactively; understand diverse viewpoints and partner needs; develop mutually agreeable solutions; and see them through to conclusion at the highest ethical standard.
• Strong work ethic, integrity, and ability to efficiently balance multiple priorities.
• 3 Days on-site – Hybrid Model – Titusville, NJ

Nice To Haves

• MS, MPH, RPh, PharmD, or PhD in Science, Pharmacy, or Healthcare preferred.
• Neuroscience therapeutic area experience.
• Direct experience as clinical scientist and/or operational management of a clinical trial, files in SharePoint, or similar systems.
• Ability to collaborate with in-sourced and outsourced trial execution resources supporting U.S. CAPLYTA Medical Affairs activities.
• Experience supporting clinical strategy and goals/objectives within a therapeutic area.
• Ability to develop and maintain focus in a changing environment.

Responsibilities

• Responsible for operational oversight of clinical trials, non-interventional research activities, post-marketing research programs, steering committees, data safety monitoring boards, and investigator meetings.
• Provides operational oversight and active contributions to the planning and development of protocols, projects, and other research-related activities.
• Contributes medical and scientific leadership to evidence generation activities, including study concept development, protocol review, data interpretation, and communication of study outcomes.
• Handles JJAR and ReCAP entries and close-out.
• Provides review of medical publications, commercial materials, and clinical study reports.
• Supports publication strategy and execution, including abstracts, posters, manuscripts, congress materials, and related scientific communications in alignment with internal processes and compliance requirements.
• Partners with internal and external authors, vendors, and cross-functional stakeholders to ensure high-quality, medically accurate, and timely publication deliverables.
• Supports development and management of clinical studies and preparation of oral and written communications for internal and external presentations, FDA or health authority submissions, and external review bodies.
• Provides medical review and scientific input for medical materials, field medical resources, congress deliverables, and evidence dissemination activities.
• Responsible for management of adverse event data collection for PSUR, PADER, and other annual regulatory obligations, in partnership with Global Medical Safety and other safety personnel.
• Co-manages and is accountable for financial budgets and contract development for CAPLYTA Medical Affairs and serves as a liaison with the Director of Strategic Operations.
• Strategically aligns and partners with U.S. cross-functional stakeholders, including Regulatory Affairs, Quality Assurance, Health Care Compliance, Privacy, and the Law Department, around requirements related to research programs and operations.
• Ensures compliance with vendor training requirements and assists in audits.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• consolidated retirement plan (pension) and savings plan (401(k)).
• long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED