Reporting to the Chief Medical Officer, the Vice President of Medical Affairs will be responsible for establishing and building the Medical Affairs function at Achaogen as well as developing and implementing the strategic medical affairs plan for the company’s lead product, plazomicin, an antibiotic that has recently successfully completed Phase 3 studies. The ideal candidate will have a deep understanding of the imperatives of a successful medical affairs group, strong leadership experience in the pharmaceutical industry, coupled with strong team management skills, and the ability to develop collaborative relationships with colleagues, KOLs, and advocacy associations.
Achaogen’s lead compound, plazomicin, will be the cornerstone product upon which the foundation for the Medical Affairs group will be built. An understanding of effective message development and medical communications planning for marketed products as well as products in clinical development is crucial. Long-term budget planning and resource allocation skills are necessary, in addition to expertise in the rules and best practices governing medical education and publications.
- Develop the Medical Affairs vision, strategy and resource requirements to successfully prepare the medical community for the launch of Achaogen’s products.
- Work closely with the commercial and clinical science teams to elicit scientific feedback from the medical community regarding Achaogen programs, including conducting Advisory Boards, participation in medical symposia, developing a publication strategy, etc.
- Identify, recruit, develop and retain key talent in the Medical Affairs functional area including building and leading a field-based MSL team.
- Collaborate with clinical sciences to direct and guide life cycle development to achieve optimal performance and results, including involvement in Phase 4 protocol design, investigator selection, trial monitoring, data management, analysis, and communication of results.
- Work closely with commercial to bring medical perspective to commercial strategies and tactics and collaborate on most efficient and effective ways for field forces to work together.
- Represent (or delegate as appropriate) Medical Affairs on the Program Teams and lead the Medical Affairs Sub Teams for Achaogen’s programs.
- Lead and collaborate on implementation of post approval data generation activities, including registries as appropriate.
- Identify, develop, and maintain relationships with current and future thought leaders, including leaders of important policy initiatives.
- Collaborate with thought leaders to develop potential clinical therapeutic ideas that will support Achaogen's vision and also develop concepts for and coordinate/supervise investigator initiated, non-registration pre-clinical and/or clinical studies.
- Drive internal and external communication strategies for disease information and clinical messaging.
- Lead team responsible for health economic and outcome research (HEOR) activities.
- Supervise and support medical information services for commercial products and sit on or supervise participation on promotional review committee.
- Regularly interact with and present to the Executive Committee and the Board of Directors and represent medical affairs on cross-functional teams.
- Infectious Diseases/Anti-infective expertise, especially in the in-hospital arena. Alternatively, experience with products in the hospital acute care area.
- 10 + years’ experience within a pharmaceutical, biotech, or healthcare organization in medical affairs, including hands-on involvement in registration dossier preparation/submission review and post marketing Phase IV and Investigator Initiated Studies.
- 10 + years’ experience presenting clinical and pre-clinical data to external audiences.
- Demonstrated success in building and leading effective home-office and field-based medical teams.
- Strong communication skills (written and verbal); individual should be a skilled communicator and relationship-builder who effectively networks internally and externally.
- Strong track record of building effective organizations and developing employees.
- MD, PharmD or PhD in a relevant field.
- Strong leadership, communication, and presentation skills.
- Proven ability to think strategically and have strong analytical skills.
- Demonstrated ability to build strong internal, cross functional as well as external relationships.
- Able to effectively handle multiple tasks and priorities in a fast-paced environment.
- Strong interpersonal skills and ability to work with others in a positive, collaborative manner.
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
- Current US work authorization required.
- Ability to travel domestically and internationally.