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Vice President, Clinical Development

3 months ago

Baltimore, United States Bicycle Therapeutics Limited Full time

Vice President, Clinical Development (MD)

Full-time Contract type: Permanent 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: Weare DedicatedtoourMission .Youcan’tchangetheworldifyoudon’thavedetermination. Weare OneTeam .Weonlysucceedwhenweworktogether. Bicycle Therapeutics is seeking a motivated physician leader with oncology drug development experience to serve as Vice President Clinical Development, based in either Cambridge, UK or Cambridge, MA. This leadership role sits within a growing clinical development organization in the oncology space involving several highly novel Bicycle (bicyclic peptide) therapeutics, designed from our proprietary platform. You will report to the Chief Development Officer and directly influence the development of novel molecules of our portfolio in oncology and help to define the broader clinical development strategy. You will interface with sites, CROs, investigators and advisors. You will collaborate internally with clinical, translational and scientific groups. This role is strategic with key interactions at the highest leadership levels and will also require you to be hands-on at the program level. You will be responsible for study conduct, program activities and clinical development plans across the portfolio. Theidealcandidate will havedeepexpertise inearly to late-stage clinical development and a demonstrable track record ofadvancingprecisionmedicinesfrom bench to bedsideto approvalwith strong scientific rigor andathorough understanding of target and disease biology. As a key member of the Development Leadership Team, you will be responsible for providing scientific, clinical and product development leadership and support for development programs across the Bicycle portfolio. Provide indirect leadership to a cross-functional, matrix team of physicians, clinical scientists and other development teams Provide specific therapeutic area expertise to enhance innovation and efficiency in clinical trial design and execution Responsible for the generation and continual refinement of the clinical development plans for Bicycle’s portfolio from IND to POC to NDA Provide key contribution to IND, NDA, PMA submissions via overseeing medical documentation and active participation in meetings with regulatory agencies Clinical lead for early development study conduct including study design, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses and study reports. Establish and develop relationships with investigators, thought leaders, in close collaboration with the Medical Affairs function Assist in scientific advisory boards, conference activities, external collaborations and partnerships Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives Medical Doctor (MD/MBBS/DO) degree Ideally a medical oncologist, or possess a deep knowledge and understanding of oncology, including companion diagnostics, precision oncology drug development paradigms, clinical pharmacologyand technical, business, and regulatory approaches Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information clearly and succinctly Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders In depth understanding of phase I-IV drug development You are passionate about clinical development and precision, and are well connected to external experts and highly credible advisors in the oncology space You have talent and ability in forging and nurturing key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs 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 10 Company holidays Competitive Family Leave Policy Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. All your information will be kept confidential according to EEO guidelines. 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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