Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma
Merck
13 days ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Responsibilities:
- Plan and direct clinical research in Oncology (Hematology) for new or marketed medicines.
- Manage late-stage clinical development cycle (Phase 2–Phase 5): strategy/design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentations.
- Lead cross-functional product development teams and provide internal scientific leadership across trial-support functions; serve as product development team spokesperson.
- Evaluate pre-clinical/translational work; develop clinical development strategies incorporating latest science, regulatory requirements, competitive landscape, and commercial considerations.
- Execute clinical strategy; plan trials (design, operational plans, settings); lead the clinical subteam.
- Monitor and manage clinical trial conduct.
- Analyze/summarize clinical findings for safety/efficacy decisions and for NDA/related outputs, study reports, and publications.
- Support business development assessments of external opportunities.
- Maintain scientific knowledge through ongoing awareness, investigator identification, communications with clinical investigators, and meeting attendance.
- Author/oversee development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20%.
May Manage:
- Clinical Directors/Senior Clinical Directors (therapeutic area leadership).
Required Experience & Skills:
- MD or MD/PhD.
- 3+ years clinical medicine experience; 5+ years industry drug development with success overseeing multiple studies/protocols to completion.
- Regulatory document authoring and regulatory agency discussion leadership.
- Scientific scholarship; clinical/biomedical research background.
- Strong interpersonal/collaboration in matrix environments.
- Clear, impactful communication (verbal/written/presentations).
Preferred Experience & Skills:
- Board Certified/Eligible in Oncology/Hematology (or related).
- Lymphoma experience; prior clinical research and publication record; product registration experience.
Required Skills (examples): Clinical trial planning, clinical research, drug development, regulatory requirements, scientific/strategic leadership.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee).
- Plan and direct clinical research in Oncology (Hematology) for new or marketed medicines.
- Manage late-stage clinical development cycle (Phase 2–Phase 5): strategy/design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentations.
- Lead cross-functional product development teams and provide internal scientific leadership across trial-support functions; serve as product development team spokesperson.
- Evaluate pre-clinical/translational work; develop clinical development strategies incorporating latest science, regulatory requirements, competitive landscape, and commercial considerations.
- Execute clinical strategy; plan trials (design, operational plans, settings); lead the clinical subteam.
- Monitor and manage clinical trial conduct.
- Analyze/summarize clinical findings for safety/efficacy decisions and for NDA/related outputs, study reports, and publications.
- Support business development assessments of external opportunities.
- Maintain scientific knowledge through ongoing awareness, investigator identification, communications with clinical investigators, and meeting attendance.
- Author/oversee development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20%.
May Manage:
- Clinical Directors/Senior Clinical Directors (therapeutic area leadership).
Required Experience & Skills:
- MD or MD/PhD.
- 3+ years clinical medicine experience; 5+ years industry drug development with success overseeing multiple studies/protocols to completion.
- Regulatory document authoring and regulatory agency discussion leadership.
- Scientific scholarship; clinical/biomedical research background.
- Strong interpersonal/collaboration in matrix environments.
- Clear, impactful communication (verbal/written/presentations).
Preferred Experience & Skills:
- Board Certified/Eligible in Oncology/Hematology (or related).
- Lymphoma experience; prior clinical research and publication record; product registration experience.
Required Skills (examples): Clinical trial planning, clinical research, drug development, regulatory requirements, scientific/strategic leadership.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee).