Contribute to the clinical development strategy for a drug or program.
Ensure execution of clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials.
Lead clinical development activities from a therapeutic area and clinical trial perspective.
Provide clinical and medical oversight of ongoing clinical trials.
Lead clinical trials and asset-level activities in a matrix team structure.
Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
Contribute to development of the Integrated Evidence Strategy (IES).
Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and trials.
Contribute to clinical development discussions and teams at global regulatory interactions.
Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA).

Requirements

Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Medical.
Experience in the global pharmaceutical/biotechnology industry
Experience in clinical research and drug development
Experience in medical monitoring activities and oversight.
Experience in leading regulatory submissions and managing global clinical trials.
Experience with ICH and GCP guidelines and regulatory requirements
Matrix team experience within a clinical development setting.

Benefits

health care and other insurance benefits (for employee and family)
retirement benefits
paid holidays
vacation
paid caregiver/parental and medical leave

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical development strategyclinical development plansclinical trials managementmedical monitoringregulatory submissionsICH guidelinesGCP guidelinesdrug developmentIntegrated Evidence Strategyclinical trial oversight

Soft Skills

strategic oversightleadershipteam collaborationcommunicationproblem-solvinganalytical thinkingproject managementinterpersonal skillsadaptabilitycritical thinking

Certifications

medical degreeclinical specialty trainingboard qualification in Internal Medicineregistration in Primary Medical