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
- 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.
Top Skills
What We Do
We are Bicycle Therapeutics, a clinical-stage biopharmaceutical company. We didn’t wait for the next advance against cancer. We created it.
Based on groundbreaking work conceived in the laboratory of Sir Greg Winter with the help of Professor Christian Heinis, we are pioneering the development of bicyclic peptides, or Bicycles® – a novel class of versatile, chemically synthesized medicines. Bicycles are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches. Bicycles represent a unique therapeutic class, combining the pharmacological properties normally associated with a biologic with the manufacturing and pharmacokinetic advantages of a small molecule, yet with no signs of immunogenicity observed to date.
Bicycles can be used as Bicycle conjugates to deliver toxin payloads and to precisely target local immune activation within tumors and as Bicycle T-cell modulators, which activate cytotoxic T-cells while circumventing the limitations of antibody and biologic therapies and better enabling combination therapy. Our lead product candidate, BT1718, is a Bicycle toxin conjugate currently being investigated in a Phase I/IIa open label dose escalation and expansion clinical trial sponsored by Cancer Research UK. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which is highly expressed in many solid tumors.
Our strategic collaborations are based on the ability of Bicycles to address a wide variety of targets. Through collaborations with AstraZeneca, Oxurion, Innovate UK and the Dementia Discovery Fund, we work with companies that have deep therapeutic expertise outside of oncology to enable us to more efficiently develop novel medicines for patients.
