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Clinical Operations Quality Compliance Senior Manager
2 months ago
Company Overview
Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These fully synthetic peptides, constrained by small molecule scaffolds, exhibit high affinity and selectivity for their targets, making them promising candidates for drug development. The company is actively advancing several clinical trials for its proprietary products, including BT8009, BT5528, and BT7480, and is exploring additional therapeutic applications through strategic partnerships.
Organizational Culture
At Bicycle Therapeutics, we prioritize a culture that embodies 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 effect meaningful change.
- One Team: Collaboration is essential for our collective success.
Position Summary
Bicycle Therapeutics is seeking a skilled and collaborative Senior Manager of Clinical Operations Quality Compliance to join our Clinical Operations team. This role involves working closely with various departments, including Clinical Quality, Clinical Development, Medical Affairs, and Safety, to uphold compliance with established processes and ensure adherence to regulatory standards. The Senior Manager will play a vital role in enhancing Clinical Operations by contributing to process improvements and supporting the implementation of organization-wide initiatives.
Key Responsibilities
The Senior Manager will be responsible for:
- Providing expertise in ICH/GCP clinical compliance to Clinical Operations and stakeholders, ensuring familiarity with current guidelines and internal procedures.
- Building strong relationships with cross-functional teams to promote process enhancements, risk management, and readiness for inspections.
- Collaborating with Clinical Quality to ensure that operational documents align with best practices and evolving organizational needs.
- Setting benchmarks for excellence in documentation related to GCP investigations, inspection readiness, and corrective actions.
- Assisting the clinical operations team in root cause analysis and ensuring timely closure of corrective action commitments.
- Supporting initiatives aimed at developing innovative processes and technologies for compliant operations.
- Facilitating inspection readiness activities within Clinical Operations.
- Providing assistance during regulatory inspections and internal audits related to clinical operations.
- Identifying and escalating significant quality and compliance risks to relevant leadership.
- Participating in due diligence and process improvement efforts as directed by management.
Qualifications
Essential:
- Bachelor's degree in a scientific or life sciences discipline.
- Experience in clinical operations or quality assurance within a CRO or pharmaceutical setting.
- Strong understanding of ICH/GCP regulations and their application to clinical trials.
- Familiarity with current regulatory requirements governing clinical research.
- Excellent strategic thinking, organizational, analytical, and project management skills.
- Commitment to quality and accuracy.
- Ability to thrive in a fast-paced environment as a self-starter and team player.
- Strong communication skills, both written and verbal.
- Attention to detail and effective follow-up abilities.
- Capability to operate effectively in a cross-functional environment.
Desirable:
- Experience with regulatory inspections, including at clinical sites.
- Background in oncology clinical trials.
- Experience in drafting SOPs and controlled documents within a clinical development framework.
Additional Information
We offer a flexible working environment and a competitive compensation package, including an annual bonus, comprehensive medical benefits, a 401(k) plan with company matching, and generous paid time off policies. Bicycle Therapeutics is committed to fostering a diverse workforce that reflects the communities we serve, and we welcome all qualified applicants.
