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Executive Director, Global Medical Affairs – Companion Diagnostic Lead
BeOne MedicinesExecutive Director leading Global Medical Affairs Companion Diagnostic program for BeOne. Engaging with cross-functional teams to support successful LPs and ensuring optimal CDx strategy execution.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develop a Global CDx medical Affairs Strategy
- Support and implement cross-functional plan for successful CDx launch programs
- Generate clinical and real-world evidence (eg IITs, testing utilization studies, diagnostic accuracy studies, clinical utility studies)
- Work closely with GMA disease lead to integrate the CDx strategy with the overall Medical Strategy.
- Lead and oversee any data generation efforts utilizing LDTs of follow-on CDx testing, aligning with overall global CDx strategy.
- Provide global (inclusive of regional) insights into pipeline programs requiring CDx
- Engage key opinion leaders (KOLs) in pathology and oncology to ensure successful launch of CDx
- Cross-functional support of market launch readiness, aligning with commercial CDx activities.
- Engage in feedback and advice from KOLs (oncologists and pathologists) on minimizing barriers and optimizing utilization of CDx, as well as validate future data generation needs.
- Internal training of medical teams and field teams, with right-size training on CDx.
- Support scientific publications
- Provide medical review of diagnostic materials (PRC, MRC etc)
- When appropriate be the GMA representative at Alliance partnerships
- Develop, track, execute and report on goals and objectives.
- Support budget planning and management.
- Be accountable for compliant business practices.
Requirements
What you’ll need- Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology.
- Extensive experience in pharma/biotech in solid tumors is required.
- 8 plus years of experience within other biotech/pharmaceutical company.
- Clinical solid tumor oncology experience and former CDx medical experience is mandatory for this role.
- Previous experience in Medical Affairs in a CDx role is strongly preferred.
- Expert understanding of incorporation of biomarker and development of CDx in a global clinical study.
- Deep understanding of LDTs and extent of data generation to support launch of CDx and utilization of companion-drug.
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Knowledge of GCP and ICH Guidelines.
- Flexibility to work with colleagues in a global setting.
- Able to engage in work-related travel approximately 25%.
- Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
- Experience with the development and support of related SOPs and policies is expected.
- Knowledge of industry standard Clinical Development IT solutions expected.
Benefits
Comp & perks- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Global CDx Strategy DevelopmentClinical Evidence GenerationBiomarker IncorporationData Generation for CDxDiagnostic Accuracy StudiesClinical Utility StudiesTesting Utilization StudiesMedical Review of Diagnostic MaterialsSOP DevelopmentBudget Planning and Management
Soft Skills
High Level of Communication SkillsInterpersonal SkillsOrganizational SkillsCross-Functional CollaborationFlexibility in Global Settings