Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials.
Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials, and study updates.
Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct.
Prepare and communicate clear overviews of trial results.
Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions to ensure resolution.
Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives.
Act as a recognized clinical expert for assigned programs.
Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for the Executive Team, Board of Directors, Advisory Boards, and the Data and Safety Monitoring Committees [DSMC])
Together with the Therapeutic Area Head for Lung, serve as a point of contact for the clinical operations personnel, clinical trial sites, and CROs for clinical science questions.
Maintains knowledge of ICH-GCP and FDA IND, and external regulations and procedures.
Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and others.
Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions.
Ability to travel, approximately 5%.

Requirements

M.S. in a biological/health science field required
Degrees such as OD, PhD, or PharmD preferred
M.S. with 8+ years Clinical science experience with 5+ years of drug development, or OD/PhD or PharmD with 5+ years of experience
Ability to interpret, analyze, and present clinical data
Thorough understanding of the drug development process
Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
Demonstrated ability to communicate and write clearly, concisely, and effectively.
Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
Understanding of trial design and statistics
Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams.

Benefits

Equal employment opportunities
No unsolicited resumes will be accepted

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial protocolsdata managementsafety monitoringmedical monitoringclinical study reportsregulatory filingsdrug developmentbiostatisticsclinical operationstrial design

Soft Skills

communicationleadershiporganizational skillsproblem-solvingcollaborationanalytical skillswriting skillspresentation skillsprioritizationtime management

Certifications

M.S. in biological/health sciencePhDPharmD