Unknown Company
Job Summary
- Lead planning and direction of clinical research activities in Oncology (Hematology) for new or marketed medicines.
- Manage late-stage clinical development lifecycle from Phase 2–Phase 5 (strategy/design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and conference presentations).
- Lead cross-functional product development teams; provide internal scientific leadership; interact with external scientific leaders.
Responsibilities may include
- Evaluate pre-clinical/translational work; develop early clinical plans and IND applications.
- Develop and execute clinical development strategies; plan and lead clinical trials and clinical subteams.
- Monitor and manage conduct of clinical trials.
- Analyze/summarize clinical findings to support safety/efficacy decisions, regulatory submissions, reports, and publications.
- Support business development assessments; collaborate across commercialization, regulatory, statistics, and manufacturing.
- Lead governance presentations between stage gates; manage Clinical Directors/Senior Clinical Directors.
Scientific/Professional maintenance
- Maintain awareness of scientific developments; identify investigators; communicate with clinical investigators; attend scientific meetings.
Education
M.D. or M.D./Ph.D.
Required qualifications/experience & skills
- 3+ years clinical medicine experience.
- 5+ years industry drug development with success overseeing multiple studies/protocols.
- Experience authoring regulatory documents; leading regulatory discussions.
- Strong scientific scholarship and biomedical research background.
- Advanced interpersonal/collaboration in matrix environments; clear verbal/written/presentation communication.
Preferred
- Board Certified/Eligible in Oncology or Hematology; lymphoma experience; prior clinical research and publication record; product registration experience.
Benefits/compensation & application
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days).
Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma in pa at Unknown Company
This position is listed as full time and onsite.