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 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, MA. 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
Reporting to the Senior Director, Clinical Operations, the Director, Clinical Operations will provide strategic direction for assigned clinical program(s) and will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Director will work closely and collaboratively in partnership with Clinical Development Operations Leadership, other development functions within Bicycle Therapeutics, and our CROs and vendors partners to ensure top quality execution of assigned program(s). Additionally, you will be responsible for optimizing cost efficiencies and continually seeking to improve clinical trial processes and resource utilization in close collaboration with all clinical partners and support functions. Lead the development strategy for assigned clinical program from a clinical operations perspective Act as the clinical operations representative to the Global Product Team(s), providing operational feasibility of clinical development plans and scenarios, including timeline, budget and resource requirements for assigned program(s) Provide support and oversight of study teams working under assigned program and ensure defined deliverables are met by proactively tracking and monitoring study specific trial management activities/systems. For early-stage programs, direct study management may be required Constantly challenge the status-quo and identify innovative solutions and improved processes for a more efficient and streamlined clinical trial execution. Provide continuous evaluation of Clinical Trial Operations processes to identify and address strengths and weaknesses to maintain competitive advantages. Participate in conferences / events / bid defense meetings and other initiatives to promote continuous departmental growth Ensure clinical trials within assigned program(s) are successfully executed with measurable results to include Key Performance Indicators. Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained Communicate with therapeutic thought leaders associated with assigned clinical program for feedback on study protocols, development plans, publications, etc. Ensure that Global and Local SOPs and ICH - GCP Guidelines / FDA Regulations are implemented in clinical trials and work closely with the Development and Quality Leadership to review current SOPs and develop new ones as needed Evaluate resourcing needs on an ongoing basis. Hire, supervise and train clinical operations personnel. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations Other duties as assigned to support the clinical operations function and the clinical development organization Qualifications
Essential: Demonstrated success in the strategic planning and operational execution clinical trials (phase 1-3) Demonstrated continuous growth of responsibilities in clinical operations Demonstrated experience in strategic program level management Demonstrated effective planning and project management skills, including risk assessment, contingency planning, and ability to prioritize Ability to handle a high volume of highly complex tasks within a given timeline Ability to lead and motivate others in a cross-functional team in a matrix environment Excellent interpersonal and negotiation skills Excellent verbal and written communication and presentation skills Excellent organizational and problem-solving skills Willingness to adapt and work under rapidly changing conditions Demonstrated track record of successful line function leadership Thorough understanding of GCP, ICH and FDA guidelines, including 21 CFR Desirable: Experience working in registration enabling trials through product approval Experience in working on oncology trials Experience in working in radiopharmaceutical clinical trials Experience contributing to regulatory documents and deliverables in a cross functional environment Experience preparing for and participating in regulatory inspections (including clinical sites) Additional Information
State-of-the-art campus environment with on campus restaurant and Montessori nursery Flexible working environment Competitive reward including annual company bonus Employee recognition schemes 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually Employer contribution to pension (employee does not have to contribute) Life assurance cover 4x basic salary Private Medical Insurance, including optical and dental cover. Group income protection Employee assistance program Health Cash Plan Access to company subsidized gym membership. Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. Cycle to work scheme Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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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 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, MA. 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
Reporting to the Senior Director, Clinical Operations, the Director, Clinical Operations will provide strategic direction for assigned clinical program(s) and will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Director will work closely and collaboratively in partnership with Clinical Development Operations Leadership, other development functions within Bicycle Therapeutics, and our CROs and vendors partners to ensure top quality execution of assigned program(s). Additionally, you will be responsible for optimizing cost efficiencies and continually seeking to improve clinical trial processes and resource utilization in close collaboration with all clinical partners and support functions. Lead the development strategy for assigned clinical program from a clinical operations perspective Act as the clinical operations representative to the Global Product Team(s), providing operational feasibility of clinical development plans and scenarios, including timeline, budget and resource requirements for assigned program(s) Provide support and oversight of study teams working under assigned program and ensure defined deliverables are met by proactively tracking and monitoring study specific trial management activities/systems. For early-stage programs, direct study management may be required Constantly challenge the status-quo and identify innovative solutions and improved processes for a more efficient and streamlined clinical trial execution. Provide continuous evaluation of Clinical Trial Operations processes to identify and address strengths and weaknesses to maintain competitive advantages. Participate in conferences / events / bid defense meetings and other initiatives to promote continuous departmental growth Ensure clinical trials within assigned program(s) are successfully executed with measurable results to include Key Performance Indicators. Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained Communicate with therapeutic thought leaders associated with assigned clinical program for feedback on study protocols, development plans, publications, etc. Ensure that Global and Local SOPs and ICH - GCP Guidelines / FDA Regulations are implemented in clinical trials and work closely with the Development and Quality Leadership to review current SOPs and develop new ones as needed Evaluate resourcing needs on an ongoing basis. Hire, supervise and train clinical operations personnel. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations Other duties as assigned to support the clinical operations function and the clinical development organization Qualifications
Essential: Demonstrated success in the strategic planning and operational execution clinical trials (phase 1-3) Demonstrated continuous growth of responsibilities in clinical operations Demonstrated experience in strategic program level management Demonstrated effective planning and project management skills, including risk assessment, contingency planning, and ability to prioritize Ability to handle a high volume of highly complex tasks within a given timeline Ability to lead and motivate others in a cross-functional team in a matrix environment Excellent interpersonal and negotiation skills Excellent verbal and written communication and presentation skills Excellent organizational and problem-solving skills Willingness to adapt and work under rapidly changing conditions Demonstrated track record of successful line function leadership Thorough understanding of GCP, ICH and FDA guidelines, including 21 CFR Desirable: Experience working in registration enabling trials through product approval Experience in working on oncology trials Experience in working in radiopharmaceutical clinical trials Experience contributing to regulatory documents and deliverables in a cross functional environment Experience preparing for and participating in regulatory inspections (including clinical sites) Additional Information
State-of-the-art campus environment with on campus restaurant and Montessori nursery Flexible working environment Competitive reward including annual company bonus Employee recognition schemes 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually Employer contribution to pension (employee does not have to contribute) Life assurance cover 4x basic salary Private Medical Insurance, including optical and dental cover. Group income protection Employee assistance program Health Cash Plan Access to company subsidized gym membership. Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. Cycle to work scheme Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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