Reporting to the Chief Medical Officer, the Vice President, Medical Affairs will create and provide strategic vision, leadership, and management for key medical affairs activities, including consistent and aligned medical and scientific communications, cross-functional medical strategy, development and execution of Advisory Boards, KOL and other key customer identification and engagement, Medical Science Liaison leadership and guidance, publication strategy and planning, CME topics of interest and grant administration, and fostering relationships with key societies, physician networks, oncology cooperative groups and academic institutions. The successful candidate will be someone who has demonstrated success in combining strategic visionary and tactical operational skills and in building medical affairscapabilities from the ground up, defining the optimal strategy, and able to effectively execute on that strategy with their team and the cross-functional organization.
- Lead and direct a world-class Medical Affairs function and infrastructure
- Collaborate closely and interface with fellow Clinical and Commercial team members and all other functions at AVEO to support our mission to develop great new cancer therapeutics and make them available to patients in need
- Leadership role in Clinical Development strategies, clinical trial design, and identification of unmet needs for investigator-sponsored, company-sponsored and cooperative group trials
- Work collaboratively with and influence AVEO external partners on global medical affairs strategies and provide oversight for execution and management of those strategies to meet worldwide needs and to enhance the value of AVEO therapeutics
- Provide senior leadership and global direction to a Medical Science Liaison team (US & EU) to support product life cycle activities, scientific/medical communications, and external scientific engagements
- Establish strong professional rapport with key internal and external customer segments
- Develop and oversee publication planning (in collaboration with clinical development), support protocol drafting, as requested, and contribute to development of evidence-based internal and external scientific/medical content.
- Lead medical review of promotional and advertising strategies and implementation
- Lead strategy and administration of external educational grants and continuing medical education support activities
- Represent the Medical Affairs function in Executive Leadership Team meetings through demonstration of organizational value (KPIs), key activities, opportunities and challenges
- Advanced Scientific or Medical degree (s)
- Demonstrated substantial Medical expertise in Oncology through clinical, research, and business activities
- Minimum of 10 years of pharmaceutical/biotechnology industry experience, at least 8 of which should be in medical affairs
- Experience building and/or running the entire Medical Affairs function in a commercialized company is required
- Demonstrated success in building effective teams, systems, and processes; proven ability to identify, select and manage a variety of external resources related to execution of medical affairs functions
- Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate
- Strategic and analytical thinking with the ability to plan and design effective medical affairs brand and life cycle strategies
- Experience and expertise in clinical trial design, interpretation of scientific data, market research, competitive intelligence tools, and medical marketing strategies
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to “roll up the sleeves” as necessary, and an appetite to lead all activities within the medical affairs functions
- Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills
- Available for domestic and international travel – up to 40% pre-COVID
- Adept in using virtual and other “not-in-person” means to engage with internal and external stakeholders
The Company’s lead candidate is tivozanib, an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective, long half-life inhibitor of all three VEGF receptors, which AVEO is seeking to develop and commercialize in North America as a treatment for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. On June 1, 2020, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory RCC and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2021. Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced RCC in the European Union plus Norway, New Zealand and Iceland. AVEO is leveraging or seeks to leverage partnerships to develop and commercialize its pipeline of products and product candidates, including tivozanib in oncology and other indications in various geographies, and ficlatuzumab (HGF MAb) in head and neck cancer and pancreatic cancer. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) drug candidates being developed for various oncology indications.
Tivozanib, ficlatuzumab, AV-203, AV-380 and AV-353 are investigational drugs and have not yet been approved by the U.S. Food and Drug Administration (FDA).