Idera’s CMC Technical Operations Lead is an opportunity for a dynamic, experienced, and highly collaborative individual to lead and develop CMC and related technical operations capabilities for Idera’s strategic and highly promising Ph2/3 oligonucleotide-based asset targeting PD-1 resistant melanoma and potentially other cancers. Scope of responsibilities for this critical role include drug substance manufacturing, formulation/process development, drug product manufacture, supply of clinical trial materials, and building the commercial supply chain. Ability to also manage CMC regulatory strategy development/execution and regulatory submission management for late-stage (phase 3, registration, post-approval) programs and based on U.S. and International requirements is desirable. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, collaborative entrepreneurial environment with broad responsibilities and opportunities. S/he will also embrace, espouse, and foster Idera’s core values of Caring, Courage, Excellence, Unity, and Passion.
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.
This role is an opportunity for a motivated, highly collaborative, and organized individual to impact the long-term value of Idera’s portfolio through efficient delivery of strategically-guided regulatory submissions. This role will also work closely with the cross-functional study/project team in contributing to the development of regulatory and overall product development strategies.
The Clinical Scientist role is an exciting opportunity for a highly motivated individual to contribute to the development and execution of the clinical strategy and plans for Idera’s Oncology programs.
Through extensive interaction with the Oncology Medical Lead and the rest of the clinical development team, this individual will have an opportunity to make an impact through strategic and scientific input as well as scientific support of Idera’s clinical programs. He/she will use their scientific knowledge and experience to help Idera build clinical expertise in the Oncology therapeutic area.
More specifically, this role collaborates with the Oncology Medical Lead and others on the team to design, plan, and implement the overall direction of clinical research projects including writing protocols, informed consent documents, Investigator’s Brochures. This individual will also coordinate activities to ensure compliance with protocol and overall clinical objectives as well as evaluate and analyze clinical data.