Senior Director, Global Medical Affairs Strategy

5 days ago

Cambridge, Massachusetts, United States Bicycle Therapeutics Full time
Job Title: Senior Director, Global Medical Affairs Strategy

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. Our company is evaluating zelenectide pevedotin, 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, we are developing Bicycle Radio Conjugates (BRCTM) for radiopharmaceutical use and, through various partnerships, are exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.

Our company is headquartered in Cambridge, UK, with many key functions and members of our 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, Global Medical Affairs Strategy is a key member of the Medical Affairs leadership team and will function as a scientific and medical expert for Medical Affairs, as well as other groups across the company. This individual will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for the current and future Bicycle portfolio. This role will include overseeing the development of global medical affairs plans and cross-functional integrated evidence plans. This leader will provide strategic input into the Global Product Teams (GPTs), either directly or through oversight of the medical affairs representation on GPTs. The successful candidate will have a successful track record of developing and driving medical strategy for multiple assets, including the effective communication of scientific data through publications, medical communications, scientific engagement, advisory boards, congress activities, and medical information. In addition, the Senior Director will support data generation and life cycle management activities as well as develop relationships with global thought leaders in support of programs. This individual will be an experienced people manager, who will lead the global medical affairs strategy function and effectively collaborate across the company.

  • Lead the development and execution of annual and long-range global medical affairs strategies and tactics to support the clinical development of the portfolio and prepare for future launch readiness
  • Develop and execute strategy for the utilization of scientific data generated by preclinical, clinical, and Real-World Evidence (RWE) studies
  • Establish the Global Medical Affairs Team (GMAT) structure and cadence at Bicycle to develop and execute on medical strategies and tactics
  • Lead cross-functional GMAT teams directly or through oversight of other medical strategy team members to develop and implement integrated medical strategy for Bicycle products
  • Ensure medical affairs strategy collaboration and strategic alignment with the field medical affairs team and support scientific communication material development to support KOL engagement
  • Take accountability for the Investigator-Sponsored Trial (IST) strategy for Bicycle programs and serve as a key individual in the development, roll-out, and operation of IST programs
  • Provide advice to the Medical, Legal, and Regulatory (MLR) review team and resolve escalations
  • 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 strategic oversight and assist as needed, in the development of publications (i.e., abstracts, presentations, manuscripts), integrated evidence plans, lifecycle management plans, congress plans, medical education plans, SOPs, ISTs, budgets, and RWE/HEOR plans
  • Present at scientific advisory boards and internal/external meetings
Requirements
  • Prior biopharmaceutical industry experience is required (10+ years of experience preferred) in medical affairs and oncology drug development
  • Advanced degree in health-related field (MD, PhD, or PharmD preferred)
  • Strong leadership skills with track-record of building and managing effective teams
  • 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, fast-paced environment with a high degree of collaboration and teamwork
  • Open, engaging, and transparent with ability resolve conflict
  • Global perspective and mindset with ability work with colleagues and stakeholders from various cultures, backgrounds, and geographies
  • 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
  • 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.

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