Senior Director, Global RWE/HEOR Lead

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, Massachusetts US. 

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 Senior Director, Global Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) Lead will be responsible for building, leading the function within medical affairs, and cultivating partnerships with cross-functional leaders in clinical development, program management, legal, regulatory, and commercial. As an essential part of this growing organization, this role will oversee the strategy and execution of activities that are integral to developing and disseminating the clinical, humanistic, and economic value proposition of our therapies. This role will work to ensure that patients can have maximized access to our therapies by generating and communicating evidence to support registration, inform healthcare decision-making, and appropriately educate payers on the value of our medicines. Developing effective collaboration and communication processes with internal and external stakeholders will be a key component of this role. This position will report into the VP, Head of Global Medical Affairs.

• Create and lead the RWE/HEOR function within medical affairs
• Develop comprehensive RWE/HEOR strategic plans and budgets for assets in development
• Develop clinical, humanistic, and economic value propositions
• Evaluate gaps in product value propositions and identify strategies and activities to fill those gaps
• Lead payer-focused research in the U.S. and ex-U.S. to obtain feedback on product profiles, value propositions, evidence gaps, and evidence generation plans
• Direct the design, conduct, and analysis of studies or other fit for purpose evidence generating activities including economic models (e.g., budget impact, cost-effectiveness) and other projects (e.g., chart reviews, systematic literature reviews, patient reported outcomes studies, payer dataset analyses) needed to secure reimbursement or differentiate our products
• Collaborate with regulatory affairs to identify, evaluate, and execute real-world evidence-generating activities that could support regulatory filings
• Lead the external dissemination of RWE/HEOR-relevant information including publications, presentations, and professional society and payer communications
• Appropriately engage with various U.S. and ex-U.S. payers (including HTA submissions) to meet requirements required to secure reimbursement
• Be an integral part of various internal teams to lead cross-functional activities that enable evidence-based healthcare decision-making
• Oversee the development of a Global Value Dossier/AMCP Dossier in partnership with cross-functional colleagues
• Identify, engage, and manage external partners (vendors) to maximize strategic planning and execution of the workflows described above
• Perform all activities in strict compliance with international governmental regulations and consistent with industry best practices and consensus recommendations
• Occasional business travel required (~20%)

Qualifications

• Advanced degree (e.g., PharmD, PhD, or MD) and background in public health, health services research, epidemiology, health economics, or a related discipline
• Prior biopharmaceutical industry experience is required (10+ years of experience preferred) in RWE/HEOR related oncology roles
• Experience launching therapies in oncology (U.S. required, ex-U.S. highly desirable)
• Comprehensive and up-to-date understanding of fundamental RWE/HEOR strategies and research methodologies
• Demonstrated excellence in developing short- and long-range strategic RWE/HEOR plans that are cross-functionally aligned and consistent with overarching business goals
• Familiarity with regulations addressing the use of RWE to support regulatory decision-making
• Proven ability to direct, with vendors, the strategic development and tactical execution of studies (e.g., chart reviews, registries) and/or the development of models (e.g., budget impact, cost-effectiveness) necessary to support regulatory or payer decision-making
• Digital fluency and familiarity of applications to support RWE/HEOR projects
• Prior management experience is desirable in anticipation of future team growth and direct reports

Additional Information

• 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. 

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.