Our client is a rapidly growing clinical-stage biotechnology company specializing in innovative antibodies and antibody-drug conjugates to target tumors and harness the immune system for cancer treatment. They have retained us to assist in their search for an Executive Director of Safety. Major tasks and responsibilities include:
- Lead and oversee signal detection and management for assigned products, including generating routine signal detection reports, tracking signals, conducting review meetings, and performing signal assessments.
- Oversee safety reviews across trials and develop comprehensive annual safety reports.
- Contribute to study design and protocol development, with a focus on safety sections and benefit-risk evaluations.
- Serve as the safety function lead, coordinating, contributing, and presenting safety findings.
- Provide medical oversight to contractors, consultants, and internal team members involved in preparing various safety-related documents.
- Contribute to the analysis and synthesis of trial data, emphasizing safety and benefit-risk assessments.
- Ensure adherence to good pharmacovigilance practices and manage GMP documentation, including meeting minutes and materials for GXP recordkeeping.
- Author or oversee the authoring of aggregate reports (e.g., DSUR, PBRER, PADER) for assigned products.
- Support process improvement initiatives and inspection readiness activities, participating in audit and inspection-related tasks.
- Collaborate with international and cross-functional teams on safety decisions for assigned products in both development and post-approval stages.
- Contribute to and review clinical trial safety documents, post-marketing safety reports, regulatory submissions, and product labeling.
- Provide insights for business development regarding safety needs in licensing activities.
We seek candidates with the following qualifications:
- Medical Science Qualifications: Medical Degree, Pharmacy Degree, Nursing Degree (BS, MS), or an MS in a health-related field.
- A minimum of 10 years of experience in the biotech or pharmaceutical industry, with at least 8 years in drug safety as a PV Scientist or in a similar role. Experience in the oncology or hematology therapeutic area is highly preferred.
- Proven experience collaborating with global business partners and leading vendors.
- Proficiency in MedDRA coding, safety databases, and clinical trial databases.
- Expertise in leading the development, authorship, and review of aggregate reports and key safety-related documents (e.g., DSUR, IND annual report, PBRER, PADER, RMPs, REMS).
- In-depth knowledge of global clinical trial safety regulations, guidelines, and reporting processes.
- Must have experience in working with multiple pipeline assets in clinical development.
- Strong analytical and creative thinking skills, with the ability to identify opportunities and resolve issues to maximize performance.
- A track record of delivering excellent results by taking initiative, trying new approaches, and adhering to company, governmental, and ethical rules.
- Must have self-awareness, with the ability to recognize personal strengths and weaknesses, seek feedback, and demonstrate resilience to enhance effectiveness.
- Strong collaboration and communication skills, with a proven ability to build positive relationships, convey complex information, and solve problems proactively.
- Proven leadership and mentoring skills, with experience managing and developing high-performing teams, including recruitment, empowerment, and cross-functional collaboration.
- Strong organizational skills, with the ability to prioritize and adapt in a fast-paced environment.
- Ability to provide clear direction and vision to foster a collaborative and high-performance team environment.
- A commitment to driving innovation and continuous improvement, with a proactive approach to personal and professional development within the team.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is included in Hunt Scanlon's list of Top 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms .