POSITION OBJECTIVE: Athenex Oncology is seeking a highly qualified Medical Affairs Leader. The successful candidate for this position will be accountable for ensuring strategic and operational excellence of the Medical Affairs function. This individual will be responsible for medical strategy, IST development and implementation, medical information, publications, communications, and medical expert engagement for the Athenex Oncology product pipeline. Athenex Oncology is actively in the process of launching its first drug, oral paclitaxel and encequidar. This will be a highly visible and critical key position reporting to the Senior Vice President, Global Oncology.
The Vice President of Medical Affairs will partner closely with colleagues in research, development, regulatory, commercial, corporate strategy, communications, legal and compliance and senior management to develop and execute short and long-term strategies for products.
Essential Job Functions/Responsibilities
- Oversee the development of medical strategies for Athenex Oncology products that can be used to guide development of robust medical plans that meet the needs of patients and the business.
- Ensure integration and optimization of the product communication strategy at the portfolio level.
- Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required). Responsible for all medical communication aspects of scientific and clinical studies, regulatory submissions, and post-approval market support;
- 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.
- Establish and maintain strong working 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 oversight for medical information activities, ensuring that responses are fully reflective of current data knowledge.
- Provide strategic input and medical due diligence to M&A and licensing activities where warranted.
- Partner with the Legal Department to ensure that all Medical Affairs activities are conducted in a manner that is compliant with Athenex's policies, procedures, and local regulatory/legal requirements
- Develop and implement Investigator Sponsored Trial program
- Able to travel up to 30% (typically required for product launch)
Required Education & Qualifications
- MD, PharmD, or PhD required with 10 to 15 years of biotech/pharma industry experience. Hematology or Oncology experience strongly preferred, but not required.
- Demonstrable executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization.
- Track record of having played a central role in product launches.
- Solid 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) 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 customers and/or consultants.
- Ability to manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations.
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient.
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, within and beyond their team, including with management and external stakeholders.
- Demonstrated ability to focus on the goal and a strong ability to analyze complex issues and drive to timely, thoughtful and realistic solutions and recommendations.
- Possesses strong written and verbal communication skills, ands ability to teach and mentor others in their team.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.