Director – Regulatory Clinical Strategy Liaison
Posted on 9/24/2023
Eikon Therapeutics
New York, NY, USA
Experience Level
Desired Skills
Business & Strategy
Legal & Compliance
  • BA level required, Advanced degree preferred in life sciences, pharmacy, or a related field
  • Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, with a focus on clinical development
  • Proven track record of successful regulatory strategy development and execution for clinical development programs
  • Strong knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations
  • Experience interacting with regulatory authorities, including participating in meetings and negotiations
  • Demonstrated ability to collaborate effectively with cross-functional teams and external stakeholders
  • Excellent communication and presentation skills, with the ability to convey complex regulatory information clearly and concisely
  • Strong leadership and mentorship abilities, with a passion for developing talent
  • Ability to adapt to a fast-paced and dynamic work environment, managing multiple projects and priorities simultaneously
  • High attention to detail, with a commitment to delivering high-quality work
  • Regulatory Strategy Development: Lead the development and implementation of regulatory strategies for clinical development programs, in alignment with business objectives and regulatory requirements
  • Clinical Trial Planning: Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, and Clinical Operations, to provide regulatory input and guidance on study design, protocol development, and clinical trial planning
  • Regulatory Submissions: Prepare and oversee the preparation of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), amendments, and other relevant documents for global regulatory authorities
  • Health Authority Interactions: Serve as the primary point of contact for regulatory authorities during the clinical development process, including preparation and participation in regulatory agency meetings and interactions
  • Compliance and Risk Management: Ensure compliance with applicable regulations, guidelines, and standards throughout the clinical development process. Identify potential risks and develop mitigation strategies
  • Regulatory Intelligence: Stay abreast of evolving regulatory requirements, guidelines, and industry trends, and proactively communicate relevant updates to internal stakeholders to inform decision-making
  • Cross-Functional Collaboration: Collaborate closely with internal teams, including Clinical Development, Medical Affairs, Pharmacovigilance, and Quality Assurance, to align regulatory strategies and provide regulatory input at key milestones
  • External Stakeholder Engagement: Build and maintain positive relationships with key opinion leaders, regulatory authorities, and external partners to facilitate the development and approval of investigational products
  • Team Leadership and Mentoring: Provide guidance and mentorship to junior team members, fostering their professional growth and development within the regulatory affairs function