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.ontribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team.
Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team.
Write and coordinate finalization of clinical study documents (e.g., protocols, informed consent documents, and clinical components of investigator brochures) in compliance with regulatory standards.
Organize expert panel, consultant, or advisory board meetings as appropriate to provide input to clinical plans
Provide clinical input to CRF design, statistical analysis plan, and drug supply planning
Collaborate with Clinical Operations in the identification and, evaluation, and selection of clinical sites and investigators, with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner.
Participate in site initiation visits as needed
Write protocol amendments, as necessary, to address safety, efficacy, or operational issues
In collaboration with Clinical Operations and the Medical Lead, Review protocol deviations (PD) reported by sites to identify cause and appropriate resolution. Review PD trends and take appropriate actions, as needed.
RN, MS, PhD or PharmD, with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred.
At least 3 - 5 years of technical operational experience in all phases of clinical trial planning, start up, conduct, reporting and publishing required.
Experience in clinical oncology is required.
Extensive, direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required.
Experience with interacting with medical monitors, development operations) and clinical investigators
Thorough understanding of ICH, GCP, and relevant regulatory requirements is required.
Internal Number: 2018-1071
About Idera Pharmaceutical
Idera Pharmaceuticals is a clinical-stage patient-focused bioharmaceutical company developing novel nucleic acid therapeutic approaches for the treatment of certain cancers and rare diseases. Idera’s immunotherapy approach is based on the modulation of toll-like receptors (TLRs) while our third-generation antisense technology is designed to inhibit the production of disease-associated proteins by targeting RNA.Our talented scientists are passionate about what matters most—people. It’s what motivates the Idera team, and it’s why we’re laser-focused on translating our pioneering nucleic acid science and technologies into medicines that will target diseases unlike any other treatment available!