Location: Remote
Contract Length: 12 Months
Pay Rate: Dependent on location
Purpose:
With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- With appropriate supervision, manages design & implementation of study protocols for clinical development program in support of the overall Product Development Plan, based on medical & scientific principles, knowledge of compliance & regulatory requirements, customers, markets, business operations, & emerging issues. Oversees project-related education of investigators, study site personnel, & study staff. Responsibility may extend from early translational development until maturity.
- Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
- Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Qualifications:
- Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable. Experience in rheumatic diseases especially lupus is preferred.
- Ability to run a clinical research study with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Must possess excellent oral and written English communication skills.
