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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 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 and selective binding to targets, making them promising candidates for drug development. The company is actively advancing several clinical trials for its product candidates, including BT8009, BT5528, and BT7480, which target various tumor antigens.
Organizational Culture
At Bicycle Therapeutics, we value a culture that emphasizes our core principles:
- Adventurous Spirit: We believe in taking bold steps to achieve remarkable outcomes for our patients.
- Commitment to Our Mission: We understand that making a difference requires unwavering determination.
- Collaborative Teamwork: Our success is rooted in our ability to work together effectively.
Position Overview
Bicycle Therapeutics, Inc. is in search of a skilled and collaborative Senior Manager of Clinical Operations Quality Compliance. This role is integral to ensuring adherence to compliance standards within Clinical Operations. The Senior Manager will work closely with various departments, including Clinical Quality, Clinical Development, Medical Affairs, and Safety, to uphold regulatory compliance and maintain the highest quality standards.
Key Responsibilities
The Senior Manager will:
- Provide guidance on ICH/GCP clinical compliance to Clinical Operations and stakeholders, ensuring alignment with current regulations and internal procedures.
- Foster strong relationships with Clinical Operations and Clinical Quality teams to enhance process improvement and inspection readiness.
- Collaborate with Clinical Quality to ensure that standard operating procedures and related documents are updated to reflect best practices.
- Set benchmarks for excellence in documentation related to GCP investigations, inspection preparations, and corrective actions.
- Assist the clinical operations team in conducting root cause analyses and ensuring the completion of corrective actions.
- Support initiatives aimed at improving compliance processes and operational efficiency.
- Lead inspection readiness activities 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 projects as directed.
- Perform additional duties as necessary.
Qualifications
Essential:
- Bachelor's degree in a scientific or related field.
- Experience in clinical operations or quality assurance within a CRO or pharmaceutical setting.
- In-depth knowledge of ICH/GCP guidelines and their application to clinical trials.
- Familiarity with current regulatory requirements governing clinical research.
- Strong strategic thinking, organizational, and project management skills.
- Commitment to quality and detail-oriented work.
- Ability to thrive in a fast-paced, collaborative environment.
- Excellent communication skills, both written and verbal.
- Proficient in managing multiple priorities effectively.
Desirable:
- Experience with regulatory inspections and oncology clinical trials.
- Proficiency in authoring SOPs and controlled documents.
Additional Information
We offer a flexible working environment, competitive compensation, comprehensive health benefits, and a supportive culture that values diversity and inclusion. All qualified applicants will be considered for employment without regard to race, religion, gender, sexual orientation, age, disability, marital status, or veteran status.
