Job Description

Reporting to the Chief Development Officer, the VP, Drug Safety & Pharmacovigilance will be responsible for leading the overall strategic direction for Safety and Pharmacovigilance and, through leadership of the team, oversee the operational delivery of safety and pharmacovigilance activities at Bicycle.

You will be a highly experienced and visionary member of the Development Leadership Team and will actively contribute to the broader clinical development strategy.

Key responsibilities

• Develop and implement a comprehensive drug safety & pharmacovigilance strategy aligned with Bicycle’s overall mission and goals
• Collaborate with senior executives to integrate drug safety & pharmacovigilance considerations into overall business strategies, clinical development plans and broader decision-making processes
• Manage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best-in-class organization
• Accountable for ensuring that appropriate resources, systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all programs
• Provide expert guidance and decision-making and will help to shape the strategy and direction of the global function to meet the organizational needs and contribute toward the overall R&D strategy
• Work with key stakeholders within the organization to develop safety and PV strategy for current products under development including proactively identifying and communicating emerging potential and/or urgent safety issues and to support signal detection and risk/benefit evaluation.
• Provide oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).
• Maintain expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities. Ensure readiness for health authority inspections and partner audits, and represent Spark in inspections, audits, and other health authority meetings as required.
• Design, direct, and conduct ongoing safety surveillance of company drug products using internal and external resources to ensure delivery of high-quality pharmacovigilance services.
• Ensure risk management/reduction strategies are developed and included in relevant documents such as clinical study protocols.
• Represent Bicycle in interactions with regulatory agencies, industry consortia, and external stakeholders on drug safety matters
• Monitor industry best practices and changes in global safety regulations and guidelines.
• Provide direction and leadership for departmental policies, SOPs, systems, communications, reporting e.g., DSUR, PSUR, periodic line listings) and vendor selection/management to ensure global regulatory compliance.

Qualifications

• Medical Doctor (MD/MBBS/DO) degree
• Significant global drug safety/pharmacovigilance experience, including experience in developing systems and processes for handling, processing, analysis, and regulatory reporting of adverse event reports, including serious adverse events
• Significant people leadership experience, proven track record of successfully leading, developing and motivating teams
• Exceptional ability to influence and inspire others, build strong relationships, and drive consensus across diverse stakeholders
• Direct experience in interacting with regulatory authorities
• Ability to formulate and articulate a clear and compelling vision for drug safety and PV that aligns with Bicycle’s long-term goals
• Experience of taking an active leadership role within a development function, acting as a business leader (beyond solely representing Drug Safety/PV); collectively as a leadership team determining long-term strategic clinical development plans
• Accustomed to influencing and interacting with Executive team and Board
• Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information clearly, succinctly and persuasively
• Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
• Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.