Director, Medical Information

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

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 Global Medical Information Director, Medical Affairs, plays an integral role in supporting Bicycle Therapeutics’ programs.  To that purpose, the Director will lead the global development and dissemination of medical information to healthcare professionals and other key stakeholders by developing internal and external communications materials, and the Director will be responsible for the processes and systems to generate evidence-based responses to external requests (product, study, safety events, etc.) throughout the lifecycle of an asset.  The Director drives global alignment of medical information in pre- and post-launch plans with cross-functional partners including Medical Affairs, Commercial, Clinical Development, Regulatory Affairs teams, and Legal teams.  In addition, the Director will provide essential medical and scientific expertise, advice, review, and oversight to support development of high-quality scientific materials, internal training materials, and communications.  Opportunities for direct ownership over key business processes and team leadership roles for eligible outstanding performers. 

This full-time position resides within the Medical Affairs function and will report to the Senior Director, Head of Medical Strategy and KOL Engagement.

• Directs the global medical information function for Bicycle Therapeutics in a matrixed environment and responsible for the development, implementation and communication strategies supporting the entire portfolio.
• Drive an integrated global medical information strategy including comprehensive scientific review, external presentations, and educational materials:
  • Including scientific statements, lexicon, and scientific narrative
  • Work with the Heads of Medical Affairs Strategy, Scientific Communication and Field Medical Affairs to develop externally facing resources, including but not limited to Standard Response Documents.
• Execute corporate strategy for data sharing and external communication tactics, particularly around program milestones.
• Leads the development, review, and approval of medically accurate, up-to-date and compliant medical information communication resources (e.g. Standard Response Documents, Frequently Asked Questions) that address the healthcare community’s knowledge gaps in information (BTC, BRC and TICA) and application of clinical data to ensure consistency in scientific exchange by US and Global Medical teams.
• Defines the medical information processes, roles/responsibilities, and technologies used to ensure operational effectiveness.
• Collaborates with Scientific Communications, Field Medical and Clinical Development to develop/maintain current, broad, and in-depth knowledge of pathophysiology, treatment, and clinical outcomes associated with all Bicycle investigational medicines.
• Leads planning, prioritization, and execution in alignment with cross-functional partners to ensure product launch preparedness in the dissemination of medical information.
• Manages, trains, and mentors Specialists, Fellows, Interns and/or others contributing to Medical Information to ensure alignment with operational objectives, excellence in execution, maintenance of quality performance, and compliance with policies and procedures.
• Develops/maintains current, broad, and in-depth knowledge of US and ex-US regulatory and advertising compliance requirements/limitations applicable to responding to unsolicited requests for medical information.
• Assists in the development/maintenance of departmental policies, standard operating procedures (SOPs), working practice documents (WPDs) and work instructions (Wis)

Qualifications

• Advanced scientific degree in biological sciences (PhD), pharmacy (PharmD) or medicine (MD)
• Vast experience in medical information or related experience in the pharmaceutical and/or biotech industries
• Experience in Medical Information/Scientific Commu