Vice President, Clinical Development (MD)

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical 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 (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule 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, Mass. 

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

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. 

The ideal candidate will have deep expertise in early to late-stage clinical development and a demonstrable track record of advancing precision medicines from bench to bedside to approval with strong scientific rigor and a thorough 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 

Qualifications

• 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 pharmacology and technical, business, and regulatory approaches 

• Outstanding interpersonal and communication skills both