Director of Clinical Affairs & Quality

Remote, USA

Job# 910

The Role

We are seeking a highly motivated and experienced Director of Clinical Affairs & Quality reporting to our CEO to join our dynamic team in groundbreaking aesthetic medicine. As the Director of Clinical Affairs & Quality, you will play a crucial role in managing and overseeing the successful execution of our single-site studies focused on physician-dispensed skincare as well as clinical trials focused on aesthetic injectable medicine and soon general health, while ensuring compliance with regulatory guidelines and maintaining the highest standards of quality and ethics.

What You’ll Do

  • Trial Planning and Design:
    • Collaborate with cross-functional teams to develop and refine trial protocols, ensuring scientific rigor and alignment with strategic objectives – specifically in the cosmetics and aesthetics space.
    • Create detailed project plans, including timelines, milestones, and resource allocation, to ensure timely execution of trials.
    • Participate in study feasibility assessments and provide input on recruitment strategies.
  • Study Oversight and Management:
    • Serve as the primary point of contact for internal and external stakeholders involved in trials, including clinic partners, investigators, study sites, contract research organizations (CROs), and regulatory authorities.
    • Coordinate and conduct patient interviews and surveys.
    • Monitor and supervise study progress, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
    • Manage and review study-related documentation, such as informed consent forms, case report forms, and study reports, with a focus on the unique requirements of skincare and aesthetic injectables trials.
    • Conduct regular site visits and/or coordinate monitoring activities to ensure data integrity, safety, and regulatory compliance.
  • Regulatory Compliance and Collaboration:
    • Collaborate with regulatory authorities, such as the FDA and Health Canada, to ensure compliance with applicable regulations and guidelines for cosmetics and aesthetics clinical trials.
    • Assist in the preparation and submission of regulatory documents specific to cosmetics and aesthetics trials, including Investigational New Drug (IND) applications, Ethics Committee/Institutional Review Board (IRB) submissions, and safety reports.
    • Establish and maintain effective working relationships with regulatory authorities to facilitate the approval process and ensure regulatory compliance throughout the trials.
  • Team Leadership and Collaboration:
    • Foster a positive and collaborative work environment, promoting open communication and knowledge sharing within the clinical operations team.
    • Provide guidance and support to team members, ensuring their professional development and adherence to company and industry standards specific to cosmetics and aesthetics trials.
  • Risk Assessment and Mitigation:
    • Identify potential risks and issues specific to cosmetics and aesthetics trials during planning and execution phases, developing mitigation strategies and contingency plans as needed.
    • Implement risk management processes, including the assessment, tracking, and resolution of study-related issues in the cosmetics and aesthetics field.
    • Foster a culture of safety and ethical conduct, prioritizing patient welfare and regulatory compliance throughout the clinical trial process.
  • Oversee Quality Control
    • Review quality controls and SOPs in place and work alongside the laboratory management and science team to ensure all are appropriate and prepared for reporting to and audits from regulatory bodies including the FDA, Health Canada, and CE mark.

What You’ll Need To Succeed

  • Bachelor’s degree in science; Master’s or PhD preferred
  • Minimum of 7 years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry, with a focus on cosmetics and aesthetics trials preferred.
  • In-depth knowledge of cosmetics and aesthetics clinical trial regulations, GCP guidelines, and industry best practices.
  • Previous experience communicating directly with regulatory bodies (eg. FDA, cFDA, Health Canada) is preferred.
  • Strong understanding of clinical trial methodologies, study design, and statistical concepts in the cosmetics and aesthetics field.
  • Excellent leadership and team management skills, with the ability to motivate and inspire cross-functional teams.
  • Effective communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders, including regulatory authorities.
  • Proven problem-solving and decision-making abilities, with the capacity to adapt to changing priorities and handle complex situations.
  • Certification in clinical research (e.g., CCRA, CCRP) is a plus.
  • Commitment to leading with humility, curiosity, and transparency, with a willingness to roll up your sleeves and dig into the work

Location: Fully remote