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Associate Director, Global Medical Affairs Myeloid

Newark Metro Area, NJ

Posted: 08/21/2018 Job Type: Scientific Job Number: JN -082018-22366
Description:
Global Medical Affairs will report to the (Associate) Scientific Director or VP Global Medical Affairs- Myeloid. He/she will be headquarters based, and will provide scientific/medical support for compounds in various stages of clinical development, as well as approved products within a therapeutic area. This individual will support the implementation of a strategic disease area medical plans, under the direction of (Associate) Scientific Director or Global Disease Lead, and in coordination with the Disease Strategic Team (DST), G3Ms in Myeloid related compounds. They will also support data analysis, publication and clinical studies. They will also assist in the evaluation and support of investigator-initiated trials. They will support Global Medical Affairs Advisory Boards. They will also support Global Medical Affairs- Myeloid Diseases Sub Teams in making agenda, taking minutes and writing reports and distributions. They will also support compassionate use or related patient access programs as directed within GMA-Myeloid.

Responsibilities will include, but are not limited to, the following:

1. Supporting responsibilities: Strategic and Tactical
Represent Global Medical Affairs in cross functional teams/meetings, e.g. Project Teams, Clinical Sub-teams, and Medical sub teams if required
Collaborate with all Regional Disease representatives and functional teams in Medical Affairs on Disease strategy and tactics
Support Medical affairs cross-functional sub team meetings
Support in the execution of Global advisory boards and steering committee meetings, but also be involved in assisting the regions on critical globally impactful advisory boards
Perform, as needed, research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning
Conduct research and provide directed analytics and valuable backgrounders, as well as provide recommendations to guide Medical Leadership Investigator Initiated Trials (IITs) decisions
Support company at professional meetings, congresses, and local symposia
2. Deliverable responsibilities: Strategic and Tactical
Assist with Global Franchise Disease Strategy and Plans
Track and coordinate with Regional & Affiliate Medical Affairs tactics in Disease Plans
Partner with Scientific Communications on developing Disease publication strategy, gap analysis, key messages in coordination with the Regions
Tracking and/or requesting of Compassionate Use or other early (expanded) access programs
High quality scientific/clinical input and review of (as needed):
o Disease strategy/plans
o Abstracts, posters, slides, manuscripts in disease area
o Educational materials in disease area including slides, webcasts, etc
o Cooperative group proposals, study concepts, and IIT proposals and protocols in disease area
o Key Opinion Leader (KOL) Steering committee meeting objectives, materials
o Clinical Development Plans (CDPs), Commercial Brand Plans, Integrated Disease Plans
o Open Research Questions process (ORQs) in disease area
o Scientific educational grant requests
o Patient advocacy grant requests in collaboration with the Advocacy team, serving as matter of expert
Support the planning and execution of Global Medical Affairs Sponsored Trials, within appropriate standards for compliance, quality, timeliness, and budget
o Seek input from experts in the field on protocol design
o Complete full protocol in collaboration with Medical writing
o Collaborate with Project Team and Clinical Operations on study start-up, to include site selection, Informed Consent development, Investigator meeting(s)
o Medical Monitoring plan, and review data on an ongoing basis
o Develop activities to enhance patient recruitment
o Review of ongoing tables, figures and listings along with patient profiles to determine safety and efficacy endpoints for company sponsored and/or registry studies.
o In collaboration with statistics review data, prepare abstracts and publications, and prepare Clinical Study Reports
Assist with scientific searches, data summaries, preparation for site visits/corporate visits/payor presentations
Track priority Medical Affairs tactics and performance to goals/budget

3. Actively engage/interact with key stakeholders, including:
Internal:
o Med Affairs partners in disease area
o Global Medical Affairs Leadership
o Marketing
o Market Access
o Clinical Research & Development
o Biostatistics
o Translational Development
o Regulatory Affairs
o Project Leadership
External:
o Investigators, Study Chairs, KOLs
o Global Study Steering Committees
o Global Scientific Advisory Boards and Regional Advisory boards with global impact (Registries)
o Advocacy groups
o Cooperative groups



Skills:
Advanced degree (MS, Pharm D, or PhD or others) in molecular biology, genomics, cancer biology or other relevant life sciences area
****Some experience in clinical /translational research and or oncology in academic medicine and/or industry ****
Minimum 1 years experience in Medical Affairs
Demonstrated understanding on Myeloid Diseases

Excellent analytical skills and some experience in translating medical/clinical information into medical affairs strategies. Experience with mining of information from tumor databases and other bioinformatics skills will be a strong plus
Proficiency in scientific and clinical data review and interpretation
Previous experience with cross-functional teams in matrix environment
Strong organization skills
Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions
Demonstrated customer focus orientation & credibility with customers.
Knowledge/application of data sources, reports and tools for the creation of solid plans.
Hard working with a can-do attitude
Possess experience creating and managing budgets
May require travel as needed.

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