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

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Job Description

The Head of Compliance & Ethics will play a critical strategic role in building and leading the company’s compliance and ethics program, reporting to the Chief Legal Officer & General Counsel and working closely with the Executive Team. You will ensure that all corporate activities—especially those related to clinical development, medical affairs, and commercial operations—adhere to the highest legal and ethical standards. You will work cross-functionally to embed compliance into everyday operations, mitigating risk while fostering a culture of ethics and integrity across the organization as we scale and approach potential commercialization.

Key responsibilities:

• The Head of Compliance & Ethics serves as the key contact on issues relating to the implementation of and compliance with Bicycle’s Code of Business Conduct & Ethics and related policies
• Develop, implement, and maintain a comprehensive compliance and ethics program, ensuring alignment across all functions, including clinical development, medical affairs, and commercial teams
• Ensure compliance with global regulatory requirements, industry standards, and internal policies across all functions
• Partner with cross-functional teams to embed ethical decision-making into clinical trials, product development, and commercial strategies
• Lead compliance training programs tailored to the unique needs of the company
• Oversee risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
• Collaborate with leadership to integrate compliance into strategic decision-making processes
• Manage reporting, investigations, and resolution of compliance violations
• Working closely with Regulatory Affairs teams, stay up to date with international and regional laws and regulations and ensure the company's adherence to these requirements

Qualifications

• Proven experience in compliance leadership within the biotech or pharmaceutical industry
• Strong understanding of compliance requirements, including across clinical development, medical affairs, and commercial operations
• Exceptional strategic thinking, with the ability to build and integrate compliance programs across multiple functions
• Demonstrated ability to work cross-functionally and influence diverse teams and leadership
• Strong knowledge of global regulatory and compliance standards (e.g., FDA, EMA) and healthcare laws
• Excellent leadership, communication, and interpersonal skills

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Job Description

The Senior Director of Isotope Supply is a remote role responsible for leading the development and establishment of robust, global isotope supply chain that takes the Bicycle Therapeutics portfolio from candidate selection through to registration and product launch. A key aspect of the role will be the leadership of vendor selection, optimization, supply for clinical manufacture, scale-up and validation of commercial supply through a period of significant growth.  In addition the role will lead the development, production, and commercialization of novel isotope generators.

This role leads the isotope supply elements of integrated development programs that deliver high quality, safe and robust radiopharmaceutical medicines for patients. In this role, you will assure quality, regulatory compliant isotope supply covering IMP, registration and product launch.

Key responsibilities

• Serve as both the strategic and operational leader to direct, oversee and manage all isotope development and supply activities
• Provide vendor management and technical oversight for the development, manufacture and supply of novel radioisotope generators in collaboration with third parties.
• Provide leadership, direction and mentorship across all levels of the organization to assure isotope development and supply strategies are understood and implemented.
• Collaborate with various functions to determine appropriate isotope development, manufacturing priorities and plans.
• Lead the development, implementation and subsequent maintenance of a phase-appropriate, isotope supply that meets internal company standards and external regulatory requirements.
• Establish a robust isotope supply that enables the launch and continued supply of Bicycle Therapeutics innovative radiopharmaceutical medicines.
• Ensure compliance to regulatory guidance through all stages of isotope development and supply.
• Ensure processes are developed, maintained, and reviewed so that ensure Bicycle sponsored GMP activities are conducted, data generated, documented, and reported in compliance with the protocol, GMP, and applicable regulatory requirement(s).
• Partner with regulatory affairs to assess new and emerging regulations and apply in a fit for purpose manner to Bicycle’s chosen isotopes and anticipate any changes that may impact the development strategies for programs.
• Collaborate with Regulatory Affairs and Quality to ensure regulatory submissions compliant to GxP and global regulations.
• Coordinate the preparation, and management of isotope aspects of regulatory agency dossiers, support Pre-Approval Inspections with CMC, Quality and Regulatory.

Qualifications

• Strong background in radiopharmaceuticals and isotope supply with a strong understanding of both FDA and EU regulations, from discovery to launch and into commercial supply.
• Ability to apply technical expertise to align the isotope supply strategy with Bicycle’s company strategy, to set functional and improvement goals.
• Exceptionally strong and wide-ranging understanding of contemporary isotope production, environmental and sustainability regulatory requirements.
• Wide ranging experience of working with complex radiopharmaceuticals from candidate selection through to regulatory submission and subsequent commercial launch.
• Strong leadership skills with the ability to inspire and develop diverse teams internally.
• Highly collaborative, strong relationship building skills with a high level of integrity and emotional intelligence.
• First class communication and influencing skills with the ability to manage multiple stakeholders.
• Resilient and able to work effectively in a demanding and fast-paced environment.   

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