Senior Director, Isotope Supply

Company Description

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (previously BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. 

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Massachusetts.  

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.  
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together. 

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, environm