Senior Manager Medical Development Oncology - H/F
AmgenFrance - parisUpdate time: June 28,2021
Job Description
Career Category
Medical AffairsJob Description
PURPOSE
•To lead the Affiliate office-based medical team in oncology
•To drive the strategy and priorities for the Affiliate medical team
RESPONSABILITIES
•Being the single point of accountability for all Med advisors and Sci Comm in oncology
•Driving the data generation, establishing and communicating the strategy for the office –based medical team
•Developing goals and tactics for the office–based medical team
•Managing resources and budget for the office–based medical team; forecast accuracy within area of responsibility
•Directing the office–based medical team in navigating products through internal governance and external regulatory portals
•Assisting the office–based medical team in interactions and communication with external stakeholders, key organizations, and institutions
•Assessing risk and identifying issues or gaps across the portfolio
•Hiring, coaching, mentoring and developing staff and team members
•Ensuring the office–based medical team TA goal accountability
KEY ACTIVITIES
•Provide leadership and strategic direction to the office–based medical team
•Assist the TA Head in identifying and resolving clinical/scientific issues
•Ensure alignment of early-stage strategy with late-stage TA objectives
•Approve the office–based medical team TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP’s for local AST’s , ISS and early access programs
•Co-chair TA Team meeting
•Foster and improve International collaboration and coordination?
•Serve as a key interface to ensure the affiliate’s voice in the global strategy
•Partner with the Affiliate marketing lead for all product lifecycle management activities
•Establish the priorities and coordinate the MSL’s team activities with the MSL manager and the GSO team
•Partner with the Biomarker medical lead for all product lifecycle management activities
•Provide input, review, approve the Affiliate lifecycle management plan and ensure alignment across the portfolio
•Provide scientific/clinical oversight for the compilation of regulatory / market access submissions across the portfolio
•Member of the Global Medical Affairs Team (GMAT) as needed
•Member of the Global Platform medical directors Forum (GPMD) as needed
•Provide clinical oversight of product safety evaluation within the AffiliateTA
•Provide support and leadership for advisory boards
•Set Affiliate office-based medical team goals and dashboards to evaluate performance
•Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability
Qualifications
•Medical Degree (MD), Pharmacy Degree, PhD or Science Engineer
Experience
•4 or more years of medical affairs in a pharmaceutical or biotechnology company
•At least transversal leadership experience
Knowledge
•Medical knowledge in the relevant therapeutic area
•In-depth understanding of medical plans and medical needs across lifecycle management of a drug
•In-depth understanding of the clinical research coordination
•Sound scientific and clinical judgment
•Understanding of regulatory and access national rules and ability to work with all the departments involved in the product lifecycle management
•Clinical Practices (GCP)
•Understanding of resourcing and budgeting
•Proven ability to lead, manage, and motivate others in a complex environment
•Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
•History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
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