Senior Medical Director
Reporting to VP of Medical Affairs, the Senior Medical Director is accountable for developing and executing an integrated global medical strategy for our DMD portfolio. This role functions as therapeutic area expert and will lead the implementation of integrated evidence generation, medical communication, and external stakeholder engagement plan.
Critical to the success of this role is close partnership with colleagues in discovery research, clinical development, pharmacovigilance, regulatory, commercial, public affairs, legal and others to maximize value proposition of our therapies.
- Develop and implement global medical strategy for successful launch and life cycle management of therapies in our DMD portfolio;
- Partner with Med Comm team to develop and implement the communications plan supporting the scientific needs and core strategy (i.e. planning for medical conference presence, abstracts, and publications, writing of abstracts/publications, as appropriate and required). Accountable for all medical communication aspects of scientific and clinical studies and regulatory submissions;
- Partner with Commercial to provide strategic medical insights to shape the portfolio strategy; provides strategic medical and scientific input and day-to-day advice to the commercial team and other relevant functions. Provide medical support for access strategy, including presentations. 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;
- Work with field and regional medical teams to develop region-specific launch-readiness strategy and tactical plan;
- 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 exchange including conferences, industry groups, Ad Boards, etc.; develop or adapt internal strategies to reflect the output of external scientific 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 Wave's policies, procedures, and local regulatory/legal requirements;
- Review and ensure compliant management of investigator-initiated studies, CME proposals, and medical education grant applications;
- Collaborate with brand marketing team(s) to ensure alignment on overall product and portfolio strategy;
- Maintain fiscal responsibility for the therapeutic area medical affairs budget
- MD (preferred), DO, PhD, PharmD or equivalent with 5-10 years of biotech/pharma industry experience. Neurology or rare disease experience preferred, but not required;
- 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 having played a central role (from a medical perspective) 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 drug development principles;
- Demonstrated ability to maintain scientific credibility while being commercially supportive, 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.