Clinical Development Executive Medical Director, Hematology

Use Your Power For Purpose

This position is foraClinical DevelopmentMedicalExecutiveDirector withinHematology.

TheClinical Development MedicalExecutiveDirectorwillbe responsible fordefining andexecuting onthe development strategyof hematology program(s). Reporting to the Global Development Product Lead the successful candidate shouldhavedemonstratedproficiencyin leading and/orsupporting development programs cross-functional collaborationandrepresent program(s)externally.

Thisposition willbe responsible forsupportingleading one or moresubteamsin clinical developmentand/or serving as the clinical lead across multiple clinical trials. The successful candidate should ideally have prior experience in clinical trialssupporting development programs health authorityinteractionsanddemonstratedleadership capabilities.

What you will Achieve

Clinical DevelopmentMedicalExecutiveDirectorResponsibilities

• May lead product specific Global Development Team

• Serves as the subject matter expert on clinical issues

• Work across the organization and onthecross-functionalGlobal Development Teamtolead develop and execute theclinical developmentplanof one or more hematology indicationsinalignment with theLifecycle Management Plan andIntegrated Product Plan

• Endorses clinical decisions in advance of GPTseniormanagementreviews orgovernancebodieswith the GDPL

• May provide oversight and management responsibilities ofmedical director(s)

• Accountable for the clinical development strategy trial design executionand delivery of trialresultswith the GDPL

• Accountable for integrating regulatorystatisticaland other internal and external stakeholderinput into study designs

• Serves as primary interface with Development Review Committee

• Oversee the development and management of clinical protocols and amendments investigator brochures and clinical study reports

• Oversee the evaluationinterpretationreportingand presentationofstudy data

• Accountable with safety for clinical evaluations and safety decisions escalating to GDPL as necessary

• Accountable with clinical pharmacologyfordefining andidentifyingoptimaldose and scheduleselection

• Accountable with regulatory for health authority interactions escalating to GDPL as necessary

• Mayparticipatein evaluating business development opportunities

• Conduct medical monitoring activities including eligibility assessment datareviewandsafety monitoring

• Leadpeer-to-peer interactions with investigator

• Serve as the point of contact for clinical issues between the study team investigators ethics committees steering committees and regulatory authorities

• Lead and contribute to development and maintenance of clinical trial and regulatory documents in collaboration with Clinical Scientist and the cross-functional team

• Overseeand provideclinical developmentleadership across several study teams

• Serves as the ClinicalDevelopmentLeadonworking groups andsubteamsincludingfor Marketing Authorization Applicationsand in business development opportunities

Strategic Guidance Clinical Insights & Interpretation

• Lead develop and execute the strategic development of therapies forone ormultiple medicines in designated therapeuticarea collaborating with theGDPL as needed

• Representsthe company in external engagements or in as committee members in joint collaborations

• Collaborate with Clinical Scientist to review and interpret clinical dataidentifykey findings and implications and communicate to internal and external stakeholders

• Maintainsa high levelof clinicalexpertiseand professional competence by staying abreast of the latest developments literature and guidelines to advise on and drive current and future clinical development plans

What You Wil Need (BASIC QUALIFICATIONS)

• Medical degreeor advanced degreewith relevant clinical/industry experience (typically 4 years).

• 7years industry experience

• 5 years of experience leading diverse teams

• Prior management responsibilitiesof medical directors or clinical scientists

Bonus To Have (PREFERRED QUALIFICATIONS)

• Board certified/eligible in oncology or equivalent

• Experience across multiple phases of clinical development and across drug classes in oncology

• Experience in leading NDA BLA or MAA

Global travel may be required

Relocation assistance may be available

Work Location Assignment:This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

Relocation assistance may be available based on business needs and/or eligibility.