Clinical Operations Quality Compliance Senior Manager
1 week ago
Company Overview
Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address unmet medical needs in various diseases. Our leading candidates include BT8009, BT5528, and BT7480, all undergoing rigorous clinical trials. We are also exploring Bicycle Radio Conjugates for radiopharmaceutical applications.
Organizational Culture
At Bicycle Therapeutics, we prioritize a culture that embodies our core values:
- Adventurous: We strive for exceptional outcomes for our patients.
- Dedicated to our Mission: Our determination drives our ability to effect change.
- One Team: Collaboration is essential for our success.
Position Summary
Bicycle Therapeutics, Inc. is in search of a skilled and collaborative Senior Manager for Clinical Operations Quality Compliance. This role is integral to ensuring adherence to regulatory standards and maintaining the highest quality benchmarks within Clinical Operations. The Senior Manager will work closely with various departments, including Clinical Quality, Clinical Development, and Medical Affairs, to uphold compliance and support operational excellence.
Key Responsibilities
- Provide expertise in ICH/GCP compliance to Clinical Operations and stakeholders, staying updated on relevant guidelines and internal procedures.
- Foster strong partnerships with Clinical Operations and Clinical Quality teams to enhance process improvement and inspection readiness.
- Ensure that all standard operating procedures and documentation align with best practices and evolving organizational needs.
- Set high standards for GCP documentation, inspection preparation, and response strategies to ensure consistent performance.
- Assist in root cause analysis and the resolution of quality events, ensuring timely completion of corrective actions.
- Support initiatives aimed at innovating processes and technologies to enhance compliance.
- Facilitate inspection readiness and provide support during regulatory inspections and internal audits.
- Identify and communicate significant quality and compliance risks to leadership.
- Engage in due diligence and process improvement activities as directed.
- Perform additional duties as necessary.
Qualifications
Essential:
- Bachelor's degree in a relevant scientific or life sciences field.
- Experience in clinical operations or quality assurance within a CRO or pharmaceutical setting.
- Thorough understanding of ICH/GCP regulations and their application to clinical trials.
- Strong project management, analytical, and organizational skills.
- Commitment to quality and detail-oriented work.
- Effective communication skills, both written and verbal.
- A proactive team player capable of managing multiple priorities.
Desirable:
- Experience with regulatory inspections and oncology clinical trials.
- Proficiency in drafting SOPs and controlled documents.
Additional Information
We offer a flexible working environment, competitive compensation, comprehensive health benefits, and a robust 401(k) plan with company matching. Employees are eligible for generous paid time off and various recognition programs.
Bicycle Therapeutics is committed to fostering a diverse workforce that reflects the communities we serve. We welcome all qualified applicants and do not discriminate based on any protected characteristic.
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Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing a unique class of therapeutic agents known as Bicycle molecules. These fully synthetic short peptides are designed with small molecule scaffolds, creating two loops that enhance their structural stability. This innovative design allows for high-affinity...
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Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle 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...
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