The Idera Medical Affairs Lead is an opportunity for an experienced, dynamic, and highly collaborative individual to apply expertise to the development and implementation of the global strategy, organization, and team responsible for Medical Affairs, a critical function working in close partnership with and bridging between Idera’s Clinical Development and Commercial teams.
With a strategic and highly promising Ph2/3 asset targeting PD-1 resistant melanoma and potentially other tumor types, this role will be responsible for ensuring clinical investigators, patients and physicians are aware of tilsotolimod and use tilsotolimod safely and appropriately through the management of Investigator Initiated Trials, the leadership of Medical Education, Medical Communications and Publications, KOL Relationship Management and Advisory Boards, HEOR, and Medical/Clinical Science liaisons.
Leading by example, the Medical Affairs Lead will partner seamlessly with and promote productive collaboration among the cross-functional team as it pursues ambitious goals. S/He will also embrace, espouse, and foster Idera’s core values of Caring, Courage, Excellence, Unity, and Passion.
Medical Communications & Publications.
· Develop and manage a strategic, forward-looking publication plan that optimizes Idera’s presence and impact
· Ensure abstracts and publications arising from Idera studies includes clear, accurate, transparent, and scientifically rigorous communication of data that inform the medical community about Idera’s pipeline products.
· Develop medical education plans to address medical and scientific issues.
· Ensure appropriate medical information expertise is applied in providing our customers scientifically-balanced medical information
Investigator Initiated Trials/Interventional and Observational Trials
· Lead internal assessment, review and approval of IIT proposals
· Supervise the conduct of IITs to ensure compliant with Clinical Supply Agreements especially safety monitoring
· Responsible for and support company sponsored MA led interventional and observational clinical trials
· Ensure there are appropriate processes in place for patient expanded Access Programs in compliance with the 21st Century Faster Cures Act, and mange requests as received
Medical/Clinical Science Liaisons
· As a functional manager, forecast and identify appropriate resource needs
· Establish and manage a team of high-performing Medical/Clinical Science liaisons who interact with key opinion leaders, clinical investigators, and other scientific / medical stakeholders to ensure they are appropriately informed about Idera’s products and clinical trials.
· Build and maintain a high performing functional team, and contribute to high performing cross-functional teams, in accordance with company values. Set and manage to team member performance expectations and develop team members’ skills and capabilities.
KOL Relationship Management
· Maintain relationships with external investigators and opinion leaders through Advisory Boards and international meetings.
· Foster research relationships with academic key opinion leaders, community hospital centers and key US community specialist physicians.
· Provide input into physician and payer market research projects.
· Establish and manage to overall Medical Affairs budget with appropriate fiscal responsibility
· As the portfolio nears commercialization, support the development of compliant promotional materials and the training of sales representatives.
• MD, PhD, or PharmD with substantial drug development experience required, including 7 or more years in the Medical Affairs capacity.
• Small biotech experience strongly preferred.
• Meaningful experience in immune-oncology strongly preferred.
• Significant travel required.