This Role is responsible for:
• Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan.
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.
• Participating and providing clinical input into safety and regulatory interactions.
• Provide clinical/scientific input during the development and execution of clinical trials.
• Interpret clinical trial data with particular emphasis on internal consistency and adherence to study protocol for individual study patients.
• Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols).
• Interact with external company vendors and consultants.
• Participate in safety assessments.
• Review and provide clinical scientific input to TLGs and safety narratives.
• Review scientific literature and integrate into practice and documents.
• Initiate database analyses to support commercial/clinical objectives.
• Contribute to the preparation of clinical study reports and regulatory submissions.
• Participate in interactions with regulatory agencies.
• Interact with key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Chief Medical Officer.
• Identify new clinical research opportunities
• PhD or MD level scientist
• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Two (2) or more years of clinical research experience and/or basic science research.
• Ophthalmology clinical research experience highly desirable.
• Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
• Medical knowledge in the relevant therapeutic area, i.e., ophthalmology.
• Sound scientific and clinical judgment.
• Familiarity with regulatory agency organization, guidelines, and practices.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Primarily an office-based position involving sitting, walking to meetings, making presentations, etc. Ability to travel ~20%.
EEO & Employment Eligibility
pSivida is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. pSivida also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.