Executive Medical Director, Clinical Development Lead – Hematology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Upper Providence • Massachusetts • Pennsylvania • United States
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Job Level
About the role
- Act as the single point of accountability for clinical development plans (CDPs) of an asset.
- Oversight of disease strategies, indications and associated clinical trial program/study data and integrity.
- Participate as a core member of the Medicine Development team or Early Development Team.
- Accountable for overall benefit:risk of a clinical program.
- Lead cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program.
- Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP execution.
- Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies.
- Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries.
- Prepare for governance discussions in close collaboration with cross-functional Medicine Development Leader (MDL).
Requirements
- Medical degree with completion of a formal primary medical clinical training program
- Advanced pharmaceutical clinical research experience in field of Hematology/Oncology.
- Experience in clinical research and drug development with a focus in multiple myeloma
- Matrix team experience within a clinical development setting
- Experience preparing clinical oncology sections for regulatory submissions and responding to health authority questions
- Experience working with oncology external investigator networks and leading advisory or investigator meetings.
- Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions.
- Cross-functional oncology medicine development knowledge and business acumen.
- Track record of scientific publications, abstracts or presentations from clinical studies.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical development plansclinical trial programclinical data interpretationregulatory submissionsoncology clinical developmentdrug developmentclinical researchsafety analysesscientific publicationsclinical study design
Soft Skills
leadershipcross-functional integrationcollaborationstrategic guidancecommunicationcoordinationcustomer insightaccountabilityalignmentproblem-solving
Certifications
medical degreeformal primary medical clinical training