Reporting to: Vice President, Medical Affairs
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work by The Boston Globe , X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.
With the April 2024 U.S. approval of our first drug XOLREMDI™ (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for X4, we invite you to share with us your aspirations and career goals.
At X4 you will find…
- A team that values grit and passion of innovative science.
- The opportunity to leverage your knowledge of Medical Affairs to support our innovative science and allow you to have a major impact on our mission to support our patients.
- A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
Your Responsibilities
Reporting to the Vice President, Medical Affairs, the Senior Medical Director is accountable for developing and executing an integrated global medical strategy for Combined Primary Immunodeficiency (PID). This role functions as therapeutic area expert and will lead the implementation of integrated evidence generation, medical communication, and medical collaborations with key external experts in Immunology, Hematology, and Genetic Testing.
Critical to the success of this role is close partnership with colleagues in discovery research, clinical development, pharmacovigilance, regulatory, commercial, patient advocacy, legal and others. This individual must be able to provide medical leadership in a matrixed environment.
- Develop and implement global medical strategy for life cycle management of therapies in PID
- Partner with Med Comm and publications team to develop the publication strategy and implement the communications plan.
- Provide medical expertise and content on regulatory submissions where appropriate.
- Partner with Commercial to provide strategic medical insights and provide medical review of product-related materials, as required (medical and promotional).
- Work cross-functionally with clinical development, HEOR, RWE, market access, and discovery teams to develop and implement an integrated evidence generation plan to support product launch(s).
- Develop and implement a well-defined and evidence-based Phase IV/life cycle management (LCM) strategy when appropriate.
- Work with field and regional medical teams to develop region-specific launch-readiness strategy and tactical plans.
- Establish and maintain strong professional relationships with key external stakeholders (medical experts, medical societies and managed care organizations, patient advocacy groups, clinical/medical stakeholders).
- Oversee the planning and implementation of external scientific advisory boards.
- Provide strategic input and medical due diligence to business development activities as needed.
- Partner with the Regulatory and Legal Department to ensure that all Medical Affairs activities are conducted in a manner that is compliant with X4’s policies, procedures, and local regulatory/legal requirements.
- Review and ensure compliant management of investigator-initiated studies, continuing medical education (CME) proposals, and medical education grant applications.
- Maintain fiscal responsibility for the therapeutic area medical affairs budget.
What You Will Bring
- MD , DO, PhD, PharmD, MSc or equivalent with 10+ years of biotech/pharma industry experience. Immunology, Hematology or Rare Disease experience required. MSc degree requires 15+ years of biotech/pharma industry experience.
- History of developing medical plans for above therapeutic areas.
- Track record of working with cross-functional colleagues to implement medical affairs plan.
- Demonstrable strategic leadership experience in Medical Affairs in a pharmaceutical/biotech organization.
- Track record of medical leadership in product launches.
- Good understanding of the US regulations that govern Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits.
- Advanced understanding of clinical medicine/clinical pharmacology, and associated disciplines (e.g., biostatistics) and medical affairs principles.
- Demonstrated ability to maintain scientific credibility and to communicate scientific results and effectively respond to data queries from HCPs, and other external stakeholders.
- Strong analytical and communication skills to appropriately interpret and communicate clinical data.
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!
About Us
Pipeline
X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
