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Medical Director, Medical Affairs - NASH
Job Opportunity at
Clinical Dynamix, Inc.
Posted on Dec 1
We are currently recruiting for a NASH Medical Director, Medical Affairs within Global Medical Affairs (GMA) and the Chief Medical Office (CMO). Working under the leadership of the Global Therapeutic Area Head, this role develops a comprehensive medical strategy for several products in development to treat Non-Alcoholic Steatohepatitis (NASH). They will work closely with Clinical Development colleagues within Research & Development as well as colleagues within Global Evidence & Value (GEV), Global Medical Excellence (GME) and the Commercial organization. This leader will contribute medical practice insights to support health economic research, publications, medical education, marketing, and regulatory functions to ensure that they are developing products and strategies that will be relevant to the market - patients, payors and physicians. This includes data generation, scientific communications and synthesis of clinical insights. This leader will provide medical practice insights to support the health economics, publications, marketing, sales, and regulatory functions to ensure that strategies that will be relevant to the market - patients, payors and physicians. The Medical Director, Medical Affairs must conduct their work activities in compliance with all internal requirements and with all applicable regional regulatory requirements.
Main Areas of Responsibilities
Drive the development and implementation of the US and International strategic and tactical plans for Medical Affairs in NASH
Establishing patient-centric relationships with international NASH and GI Thought Leaders
Measure and communicate performance and progress on project milestones
Represent NASH in the US and International Medical Affairs on cross functional Teams
Ensure alignment of broader Medical Affairs functional activities to the Medical Affairs strategic plans
Provide direction to Medical Science Liaison (MSL) plans and develop educational parameters for independent medical education (if applicable)
Support international CMO colleagues to facilitate implementation of strategies and tactics
Contribute to Commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment.
Advise and support Commercial colleagues in the development of their marketing plans and materials
Lead the development and execution of Medical Affairs data generation plans
Collaborate with the External Scientific Communications team to contribute to robust publication plans for NASH
Be responsible for MSL materials and content used in communications for NASH
Establish and maintain internal organizational links with the broader R&D, Commercial and other departments to ensure appropriate support for NASH.
Establish and maintain relationships with top tier thought leaders in the NASH therapeutic area to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure thought leader development and communication is optimized. Collaborate with health outcomes to establish scientific and clinical credibility with payers, managed market/market access and healthcare decision makers.
Assess external CME, IIT proposals and concepts related to NASH to ensure alignment with strategy
Deliver portfolio-related clinical presentations and participate in prioritized scientific congresses.
Responsible for collecting external insights to inform strategy (e.g. via advisory boards, strategic insights, field insight discussions)
Strong preference for candidates with experience NASH (hepatology) as well as experience as a Medical Director. Additional experience working with late phase studies, publications and field-based medical affairs preferred.
Must have a solid understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
Substantial knowledge of Medical Affairs principles, study design and publications.
Handle and prioritize multiple
Ability to work effectively in a team/matrix environment
Ability to influence others without direct reporting relationships
Planning, organizational, project management and analytical skills
Oral and written communication
Conflict management and resolution
Interpersonal and networking skills
Cross-cultural sensitivity/Global perspective
Medical degree (MD), PhD, PharmD and/or other higher scientific degree.
Minimum of 10 years biopharmaceutical/medical device industry experience, including experience with late phase studies, publications and field-based medical affairs roles. 2 years of therapeutic area relevant experience required; Min. of 5 years Medical Affairs experience required.
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