Senior Director/Director, Medical Affairs Strategy

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, MA USA

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/Director, Medical Affairs Strategy will function as a scientific and medical expert for Medical Affairs, as well as other cross-functional groups across the company. This individual will be responsible for developing and executing medical affairs strategies, integrated evidence plans, and tactical plans for Bicycle asset(s). This person will provide strategic medical input into the Global Product Teams (GPTs) and represent medical affairs on GPTs as assigned by the Senior Director, Global Medical Affairs Strategy Lead. This candidate will have a successful track record of developing and driving medical strategy, including the effective communication of scientific data through publications, medical communications, scientific engagement, advisory boards, congress activities, and medical information. In addition, this individual will support data generation, life cycle management, and launch readiness activities as well as develop relationships with Key Opinion Leaders (KOLs) in support of assigned programs. This individual should have a strong background and prior experience in the field of solid tumors, with the ability to translate scientific goals into actions that align with cross-functional partners and business objectives.

• Responsible for global and/or U.S. medical affairs strategic and tactical planning, in coordination with the Global Medical Affairs Strategy Lead and other cross-functional team members
• Lead U.S. medical affairs launch readiness planning, activities, tracking, and execution
• Lead a cross-functional Global Medical Affairs Team (GMAT) for assigned Bicycle asset(s), which includes developing, coordinating, and executing on medical strategies and tactics
• Ensure strategic alignment with the field medical affairs team and support scientific communication material development to support KOL engagement
• Develop and align scientific messages with cross-functional partners, including investor relations and corporate communications
• Facilitate the utilization of scientific data generated by preclinical, clinical, and Real-World Evidence (RWE) studies in scientific exchange
• Assist in the development, roll-out, and operation of an Investigator-Sponsored Trial (IST) program and strategy for assigned Bicycle asset(s)
• Serve as a medical reviewer on the Bicycle Medical Review Committee and promotional review processes
• Assure close but appropriate coordination of medical affairs strategies and activities with clinical development, clinical operations, commercial, translational, research, corporate communications, investor relations, and other key Bicycle stakeholders
• Provide medical perspectives and assist in the development and strategic timing of publications (i.e., abstracts, presentations, manuscripts) and clinical guidelines submissions
• Lead the development and execution of advisory boards, including presentation of scientific content and facilitation of meetings
• Engage Key Opinion Leaders (KOLs) in coordination with the field medical team and as needed

Qualifications

• Prior biopharmaceutical industry experience is required (7+ years of experience preferred) in medical affairs and oncology drug development
• Advanced degree in health-related field (MD, PhD, or PharmD strongly preferred)
• Strong leadership skills with track-record of leading with and without authority
• Ability to think strategically and translate scientific information into medical affairs strategies
• Ability to understand complex information and simplify into concise scientific messages
• Ability to navigate and succeed in a dynamic environment with collaboration and teamwork
• Open, engaging, and transparent with ability resolve conflict
• Strategic thinking with strong business acumen and the ability to prioritize
• Excellent communication and presentation skills with the ability to influence key stakeholders
• Proficiency in clinical trial data review and interpretation
• Knowledge of U.S. and ex-U.S. healthcare systems and understanding of region regulatory requirements
• Occasional business travel required (~25%)

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.