Senior Medical Director Global Companion Diagnostics amp Biomarker Lead

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Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at
****Astellas is announcing a Senior Medical Director, Global Companion Diagnostics & Biomarker Lead
opportunity.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The Senior Medical Director, Global Companion Diagnostics and Biomarker Lead will lead the Medical Affairs related strategic support for all biomarker and companion diagnostics (CDx) relevant products both in the Early Stages of Development and pre/post launch phases globally. Responsible for creating and executing effective medical and scientific strategies for successful CDx development and launch.
Provides a strategically focused Medical Affairs perspective to CDx plans with the aim of ensuring that each product requiring a biomarker and CDx is most efficiently launched to bring added value to the relevant patient groups. The individual will work in collaboration with all relevant MA colleagues and cross functional stakeholders across brands.
As a Senior Leader within Medical Affairs the Diagnostic/Biomarker Lead pprovides overall global vision and direction for the diagnostic-related strategy and eensures that all activities align with the CMP and are vetting through the CMT. In addition, all activities must comply with all Astellas policies and SOPs globally and the diagnostic/biomarker lead is accountable for the optimal allocation and management globally of Medical Affairs resources for the relevant products where a diagnostic is being developed.
This position is fully accountable for timely execution of these MA deliverables within budget, and proactively manages the risk of not meeting timelines and budget.
Essential Job Responsibilities:
Lead the development and coordination of the overarching biomarker and CDx global medical strategy for all applicable brands
Collaborate with internal stakeholders in providing a Medical Affairs perspective to CDx and Biomarker identification, development and launch for Oncology current priority products and future portfolio.
Partner with counterparts in Development, Commercial and RA to define the CDx strategy for the TA portfolio.
Provide external medical and business environment perspectives to all MA CDx strategies and processes; share and implement new insights on evolving CDx implementations in TA.
Lead and build out relationships with Global Diagnostic partners, testing labs and KEEs in the Diagnostics field.
Support ESMA team and Core Medical Teams (CMT) with appropriate CDx and Biomarker strategies and the execution of key tactics.
Support regions and affiliates for training, planning and executing CDx and Biomarker related launch plans, Core Medical Plan (CMP) and related tactics
Plan for and oversee CDx and Biomarker evidence generation activities and publications for TA compounds
Assess, plan and support execution of internal and external medical education needs for CDx of TA products in new disease areas/innovative treatment modalities with biomarker and CDx requirements.
Provide CDx and Biomarker medical expertise related to new product licensing and acquisition opportunities
Support and be a role model for a matrix leadership culture to ensure effective and transparent cooperation and communication across the TA and Medical Affairs and drive a continuous improvement approach to MA.
Be able to lead or co-lead company projects across disciplines.
Foster a culture of 100% compliance that embodies the One-Astellas Way
Quantitative Dimensions:
The Senior Medical Director, Companion Diagnostic and Biomarker Lead is accountable for development and execution of relevant MA CDx and Biomarker Strategic Plans within budget and timelines.
Direct accountability for ESMA and CMP CDx/biomarker deliverables (specific tactics) within timelines and budget and will demonstrate solid leadership and executive presence with both internal and external executive leaders.
Budget accountability for approximately $10M with cross-functional stakeholder responsibility for 30 people supporting the biomarker/CDx globally
Support and provide expertise to regional medical and commercial activities involving biomarkers/CDx inclusive of vendor support
Global leadership of all relevant biomarker publications in collaboration with the pubs team (includes development studies as well as regional medical and HEOR)
Organizational Context:
Reports to the VP Therapeutic Area Head
Works closely with MA and matrix teams including ESMA, CMT, CPED.
Collaborates with:
Medical Affairs:
Executive Director/Vice Presidents TA Heads in MA groups, Executive Director HEOR TA Lead, ESMA Lead, CMT Leads
Development:
VP Medical Sciences -- Oncology, Senior Director/Executive Director Global Development Project Leads, Core/Project Team members, Global Medical Leads.
CPED:
Sr. Director, Group Lead Biomarkers/CDx, Exec Dir CPED Science Oncology
RA and PV:
Executive Director TA Heads
Commercial:
Senior Vice President SBM Global TA Head, GPST co-leads, Senior Director Companion Diagnostics
Portfolio Strategy:
Senior colleagues
Requirements
Qualifications:
Required:
Medical Degree (MD) or equivalent (PhD., PharmD). Holds an appropriate degree and certification recognized by one of the leading governing bodies from around the globe.
Significant diagnostics and biomarker experience: At least 5 years total experience in CDx development, launch and/or Academic/teaching. At least 2 years of Pharma experience.
Has in-depth knowledge of TA/disease/product and is able to operate across multiple products within TA. Able to effectively communicate knowledge (TA/disease/product) to others.
Has a good understanding of the regulatory environment and be able to contribute to CDx strategies.
In depth knowledge of all stages of drug development and launch with biomarkers and CDx.
Advanced knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities.
Fluent in written and verbal business English.
Experience in managing project budgets with demonstrated ability to apply pro-active risk management on budget and timelines.
Has worked in global matrix structure.
Preferred:
Medical specialty and/or experience in relevant therapeutic area.
Work experience across multiple cultures and countries / regions.
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
*LI-CH1
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Location
IL, Northbrook
Category
Medical Affairs

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