Director, Clinical Safety at Quantumleaphealth

TITLE: Director, Clinical Safety

Salary Range: $153,130 - $205,000/year

Job Description: Build the Clinical Safety function capability to serve as key support for the clinical trial portfolio and medical decision-making. Provide dynamic leadership, strategic direction, and governance of patient safety and pharmacovigilance activities across QLHC portfolio. Invest deeply in team development plans; serve as a coach and mentor to others. Direct the Safety team to achieve on-time quality deliverables and contractual project requirements. Oversee serious adverse event handling, including individual case reviews, assessment of expectedness and relatedness, and collaboration with regulatory partners on expedited reports, as appropriate. Direct the development, implementation, and communication of the clinical safety vision, goals, core capabilities, and values while championing clinical safety processes. Conduct internal audits and be a lead participant in regulatory inspections. Approve and oversee the implementation of governing documents, including SOPs, Operating Guidelines, and Safety Management Plans. Oversee the clinical safety review conducted by the safety working groups, trial arm chaperones, platform PIs, and clinical site PIs. Represent QLHC in interactions with the FDA and other strategic partners in addressing clinical safety matters. Direct the development of safety sections for clinical documents, including reviewing and approving safety protocols, IND Annual Reports, Arm Termination Reports, and other necessary documents. Assess clinical trial agent safety by interpreting safety information in Investigator Brochures and USPI for adverse event expectedness and risk mitigation strategies. Establish strong, effective working relationships with internal (QLHC) and external (I-SPY professors and safety working group) stakeholders to achieve clinical safety compliance and objectives by supporting the clinical programs and patient care. Proactively assess compliance issues and risks, providing guidance and expertise in GCP compliance standards. Negotiate safety data exchange agreements between partners, as required. Assess and communicate critical risks and proposed solutions to internal senior leadership and key external stakeholders, requiring diplomatic and objective representation of the issue(s). Telecommuting permissible from anywhere in the US.

Requirements: A Bachelor’s degree (or foreign degree equivalent) in Pharmaceutical Science or other related field and four (4) years of experience in Clinical Research or Pharmacovigilance or in the job offered or related role.

Experience and/or education must include:

• Clinical Trial Experience;
• Adverse Event (AE) Management and optimizing AE intake procedures;
• Adverse Event coding using Pharmaceutical dictionaries, particularly MedDRA;
• Case processing quality control;
• Safety management plans, aggregate safety reports, and safety signal detection;
• Understanding of Good Clinical Practices, and clinical research ethics;
• Liaise with clinical trial sponsors and subject matter experts, including medical monitors, to address project-specific safety requirements;
• Evaluating compliance related concerns, quality issues, and process deviations and supporting the implementation of Corrective and Preventive Action (CAPA) measures;
• Ensure full adherence to regulations, guidance documents, and standard operating procedures (SOPs).

TO APPLY: Please reference Job ID: 7476250 and apply online at: https://www.quantumleaphealth.org/about-qlhc/working-with-us/