VP, Biometrics at Bicycle Therapeutics

Lexington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Oct, 26

Salary

325000.0

Posted On

15 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Clinical Study Design, Oncology Drug Development, Regulatory Advocacy, CRO Management, Adaptive Designs, Bayesian Trial Design, CDISC Standards, SAS, R, Python, Data Governance, Radiopharmaceutical Methodology, Clinical Programming, Statistical Analysis Plans, ICH GCP

Industry

Biotechnology Research

Description

Company Description About Bicycle Therapeutics 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 nuzafatide pevedotin (formerly BT5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents;; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle® technology to develop therapies to treat diseases in a range of therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA. For more information, visit bicycletherapeutics.com 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 Vice President, Biometrics will build, resource, oversee, and play a hands on role for the Biometrics organization. This leader holds ultimate accountability for clinical study designs, statistical methodologies, data analysis, and interpretation of results in close collaboration with partner functions across Clinical Development, Operations, and Regulatory Affairs. As a key member of the Development Leadership Team, the VP provides strategic statistical input into Bicycle's drug development portfolio, representing the company in interactions with global Health Authorities (FDA, EMA, MHRA, RoW agencies) and contributing to the advancement of our oncology and radiopharmaceutical clinical pipelines. Additionally, this role supports early-stage research and translational sciences as required. The ideal candidate possesses deep global clinical development expertise in oncology, combined with an outstanding track record of managing complex portfolios, driving innovation in applied statistical methodologies (including adaptive designs), and leading teams in a high-growth, agile biotechnology environment. Experience in Bayesian Trial design and radiopharmacology experience is preferred. KEY RESPONSIBILITIES Operational Leadership: Ensure highly effective and compliant global operations in biostatistics and clinical/statistical programming, establishing industry-best standard operating procedures (SOPs). Maintaining inspection-ready documentation and ensuring ICH GCP compliant, demonstrable data flow and data governance stewardship across the portfolio Strategic Input: Lead and actively contribute to Biometrics participation in clinical development plans (CDPs), clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications. Statistical Integrity: Drive the development, implementation, and execution of robust statistical analysis plans (SAPs) that support clinical protocols, ensuring absolute data integrity, accuracy, and regulatory compliance. Radiopharmaceutical and BRC Support: Provide specialized statistical guidance for the expanding Bicycle® Radioconjugate (BRC®) portfolio, incorporating imaging endpoints, dosimetry analysis, and theranostic study designs. CRO & Vendor Management: Oversee the strategic selection and management of CRO partners, holding accountability for the quality, consistency, and timeliness of external programming deliverables (such as SDTM/ADaM datasets and TFLs). Regulatory Advocacy: Represent Bicycle as the lead statistical expert in interactions with global regulatory bodies (FDA, EMA, MHRA), aligning statistical strategies with current guidelines (including Project Optimus). Team Building & Mentorship: Recruits, retains, and mentors a high-performing biostatistics and programming team, fostering a culture of scientific excellence, accountability, and continuous professional development. External Engagement: Cultivate strong collaborative relationships with external investigators, steering committees, and academic thought leaders, actively contributing to the broader biostatistics community. Qualifications Background: Proven experience leading a biometrics function, with a PhD qualification or a Masters with equivalent industry experience. A hands on leader who is able to support day to day statistical tasks. Clinical Expertise: Proven track record in oncology drug development (Phase I through Phase III). Experience or strong familiarity with radiopharmaceutical/imaging clinical trial methodology is highly desirable. With the ability to successfully operate in a matrixed clinical development environment. Regulatory Acumen: Comprehensive, up-to-date knowledge of ICH, FDA, EMA, and global regulatory guidance documents, with direct experience presenting statistical strategies to regulatory agencies. With the ability to bring a target through development lifecycle to a successful MMA. Statistical Methodologies: Deep expertise in advanced theoretical and applied statistics, including adaptive designs, Bayesian approaches, and master protocols. Technical Proficiency: Expert-level understanding of statistical software (SAS, R, Python) and industry data standards (CDISC), with experience leading open-source package validation and modern submission standards. Leadership & Influence: Highly collaborative leader with exceptional interpersonal, communication, and negotiation skills; a proven ability to lead by example and thrive in a fast-paced, cross-functional environment Urgency & Quality: An entrepreneurial self-starter who balances a strong sense of urgency and rapid clinical execution with rigorous scientific standards and ethical integrity., with full compliance of ICH GCP. Additional Information 401(k) plan with a 4% Company match and immediate vesting 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 Employee assistance program (EAP) Time off (eligibility to accrue up to 23 paid time off days per full year worked, the option to buy up to 5 additional days & 10 company nominated holidays) 10 Company holidays Competitive reward including annual company bonus Employee recognition schemes Enhanced parental leave policies Flexible working environment Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 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. 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. Department: Development Compensation: USD 260000 - USD 325000 - yearly

Responsibilities

The VP of Biometrics will lead the biometrics organization, overseeing clinical study designs, statistical methodologies, and data analysis for oncology and radiopharmaceutical pipelines. This role involves representing the company before global health authorities and managing CRO partners to ensure regulatory compliance and data integrity.