Senior Director - Isotope Supply

4 days ago

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Logo of Bicycle Therapeutics

Bicycle Therapeutics

Drug Discovery • Phage Display • Peptide Therapeutics • Biotechnology

201 - 500

💰 $175M Post-IPO Equity on 2021-10

Description

• Lead global isotope supply chain development from candidate selection to launch. • Manage vendor selection and supply optimization for clinical manufacture. • Assure quality and regulatory compliance for isotope supply covering IMP and product launch. • Collaborate with various functions for isotope development and manufacturing priorities. • Ensure lottery compliance with regulatory guidance throughout isotope development.

Requirements

• 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, environmental and sustainability regulatory requirements. • Wide ranging experience of working with complex radiopharmaceuticals from candidate selection through to regulatory submission and subsequent commercial launch. • Strong leadership skills with the ability to inspire and develop diverse teams internally. • Highly collaborative, strong relationship building skills with a high level of integrity and emotional intelligence. • First class communication and influencing skills with the ability to manage multiple stakeholders. • Resilient and able to work effectively in a demanding and fast-paced environment.

Benefits

• Flexible working environment • Competitive reward including annual company bonus • Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company • Health and Dependent Care Flexible Spending Accounts • 401(k) plan with a 4% Company match and immediate vesting • Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days • Employee assistance program • Employee recognition schemes • 10 Company holidays • Competitive Family Leave Policy • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

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