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Senior Vice President, Safety and Pharmacovigilance
2 months ago
Bicycle Therapeutics is a pioneering clinical-stage biopharmaceutical organization focused on developing an innovative class of therapies known as Bicycle molecules. These fully synthetic short peptides are uniquely structured with small molecule scaffolds, forming two loops that enhance their binding affinity and selectivity for therapeutic targets. The company is advancing several promising candidates, including BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4; BT5528, a BTC aimed at the historically challenging target EphA2; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) that targets Nectin-4 while stimulating CD137. In addition, Bicycle Therapeutics is exploring Bicycle Radio Conjugates (BRCTM) for radiopharmaceutical applications and is leveraging partnerships to expand its therapeutic reach beyond oncology.
Bicycle Therapeutics operates with a strong emphasis on culture, with all employees embodying our core values:
- Adventurous: We believe in taking bold steps to achieve remarkable outcomes for our patients.
- Dedicated to our Mission: Our determination drives us to make a meaningful impact.
- One Team: Collaboration is essential for our success.
Reporting directly to the Chief Development Officer, the Senior Vice President of Drug Safety & Pharmacovigilance will spearhead the strategic vision for safety and pharmacovigilance within the organization. This role requires a seasoned and forward-thinking leader who will contribute significantly to the overarching clinical development strategy.
Key Responsibilities
- Formulate and execute a comprehensive strategy for drug safety and pharmacovigilance that aligns with the mission and objectives of Bicycle Therapeutics.
- Collaborate with executive leadership to ensure drug safety and pharmacovigilance considerations are integrated into business strategies and clinical development plans.
- Oversee the patient safety and pharmacovigilance operations, ensuring the organization evolves into a best-in-class entity.
- Ensure that the necessary resources, systems, and processes are established for the evaluation and reporting of safety information in compliance with global regulatory standards.
- Provide expert guidance and strategic direction for the global pharmacovigilance function, aligning it with organizational needs and R&D strategies.
- Work closely with internal stakeholders to develop safety and pharmacovigilance strategies for ongoing projects, proactively identifying and addressing potential safety issues.
- Supervise the processing of Serious Adverse Events (SAEs) and ensure compliance with regulatory requirements and Good Clinical Practice (GCP).
- Maintain up-to-date knowledge of ICH guidelines and health authority expectations to ensure compliance in all activities.
- Lead ongoing safety surveillance of drug products, utilizing both internal and external resources to deliver high-quality pharmacovigilance services.
- Develop risk management strategies to be included in relevant clinical documentation.
- Represent Bicycle Therapeutics in discussions with regulatory agencies and industry groups regarding drug safety.
- Monitor industry best practices and changes in global safety regulations.
- Provide leadership for departmental policies, systems, and vendor management to ensure global regulatory compliance.
- Medical Doctor (MD/MBBS/DO) degree.
- Extensive experience in global drug safety and pharmacovigilance, including the development of systems for adverse event reporting.
- Proven leadership experience with a track record of developing and motivating teams.
- Exceptional ability to influence stakeholders and drive consensus.
- Experience interacting with regulatory authorities.
- Ability to articulate a clear vision for drug safety and pharmacovigilance that aligns with long-term goals.
- Experience in a leadership role within a development function, contributing to strategic clinical development plans.
- Strong interpersonal and communication skills, with the ability to convey complex information clearly.
- Effective collaboration skills to achieve results and resolve conflicts.
- Flexible working environment.
- Competitive compensation package including annual bonuses.
- Comprehensive medical, dental, and vision insurance for employees and their families.
- 401(k) plan with company matching.
- Generous paid time off policy.
- Employee assistance program and recognition schemes.
- Eligibility for stock options in Bicycle Therapeutics plc.
