Full-Time CMC Senior Clinical Supplies Manager

Exciting opportunity for an experienced CMC Senior Clinical Supplies Manager (Radiopharm) to join the Bicycle team and support preclinical & clinical portfolio. Reports to Director, Clinical Supply Chain.

Responsibilities:

• Ensuring Investigational Medicinal Product (IMP) is labelled, packaged, released, shipped, and distributed to clinical sites timely and per cGMP/GDP/GCP guidelines for radiopharm programs.
• Managing inventory and IMP use forecasting, aligning IMP manufacturing with projected clinical usage.
• Managing clinical supply chains for international clinical studies (including radiopharm). Strong practical understanding of IMP distribution regulations.
• Ensuring continuous IMP supply for assigned trials through monitoring, liaison with CMC & clinical ops, & proactive external distribution/IRT provider management.
• Day-to-day inventory and supply chain management for all Bicycle Therapeutics clinical programs.
• Collating & managing IMP inventory (internal/external partners).
• Establishing appropriate packaging, labeling, distribution for radiopharmacy study drugs.
• Implementing & monitoring inventory management plans, including IRT, for complex radiopharmacy supply chains.
• Managing vendors.
• Staying current with cGMPs, GCPs, & regulatory requirements.
• Attending study meetings and representing Clinical Supply Chain status.
• Collaborating on cross-functional study management.
• Utilizing Clinical Trial Supply Chain best practices to suggest improvements & develop training materials.
• Additional duties as needed.

Requirements:

• Relevant education/experience.
• Demonstrated radiopharm supply chain experience.
• Project management experience.
• Experience with multiple global clinical trials.
• Vendor management experience.
• Strong interpersonal & communication skills, presentation skills to senior management.
• MS Office proficiency.
• Teamwork, motivation, leadership skills, independent work.
• Flexible, collaborative style with internal/external teams.
• Ability to handle complex information.

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