Implaion Recruiting

Operations

• Play a pivotal role in commercialization of their first product
• Provide pharmacovigilance leadership and oversight
• Prepare for and lead FDA inspections
• Ensure alignment of safety strategy across departments
• Build and scale pharmacovigilance systems from early-stage to commercial readiness
• Establish and maintain inspection-ready documentation
• Manage safety vendors and ensure compliance

Senior Director – Pharmacovigilance, PV Operations

Director

• Provide strategic and operational leadership for clinical development programs across one or more therapeutic indications
• Lead multiple cross-functional workstreams to drive program success
• Collaborate closely with Clinical Operations and Program Management to support site engagement, trial execution, and vendor oversight
• Develop and maintain strong relationships with investigators and key opinion leaders
• Represent the organization at investigator meetings and scientific conferences
• Deliver protocol-specific and therapeutic training; respond to trial-related medical inquiries from sites and investigators
• Review incoming medical data, including laboratory, safety, and efficacy outputs
• Contribute to the development of study protocols and regulatory documentation
• Travel occasionally for study oversight and internal meetings

Senior Director, Clinical Development

Compliance

• Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation.
• Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
• Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization.
• Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
• Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
• Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
• Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
• Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
• Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action.

Senior Director – Pharmacovigilance, PV Operations

Senior Director, Clinical Development

VP, Regulatory Affairs