Medical Affairs Director II

Job Description Summary
As a Global Medical Affairs Director, you will contribute to the development and implementation of the medical strategy across the life-cycle of our assets in ASCVD with a focus on evidence generation and execution as well as providing the foundation for a compelling and cohesive scientific narrative. In addition, you will provide medical leadership for GMA and cross-functional teams in addressing and delivering strategic pre-launch, launch and post-launch activities directed at clinical adoption and access for patients.

Job Description

• Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GMA supportive functions (Real World Evidence, SciComms, Field Medical), Clinical, Biomedical Research, Marketing, Novartis local medical organizations, as well as external customers e.g. medical experts (MEs), healthcare system stakeholders and patient advocacy groups.
• For assigned Medical Affairs studies (Phase IIIB-IV without regulatory impact) within program/disease area provide medical scientific input and/or develop study protocols and/or deliver MA studies as the Medical Lead in the Clinical Trial Team.
• Provide medical scientific input for the assigned program/disease area to co-develop with the appropriate functions an integrated Product Strategy (IPS), MA strategy and related MA plan as well as develop the medical affairs section of the clinical development plan.
• Provide medical scientific input into the development and dissemination of scientific data internally and externally, e.g. MSL training, Congress activities.
• Contribute to the review of scientific documents i.e. Scientific Review Committee, abstracts, posters, manuscripts.
• Provide guidance to CPOs related to their MA study program; review, approve and follow up on local MA studies.

Key performance indicators:

• Achievement of annual targets for medical activities.
• Evidence generation and communication vs. quality / time target.
• Medical Affairs / Program budget execution vs. target.
• Compliance standards adherence.

Minimum Requirements:

• MD with specialty with board certification or equivalent, with ≥ 3 years of clinical research experience required or PhD with unique knowledge for successful clinical program development and execution, with ≥ 3 years of clinical research experience required.
  • Medical Affairs and/or Market access experience.
  • Medical and/or scientific expertise within disease area required.
  • Experience in having launched a medication in a regional/global market.
  • Demonstrated ability to establish strong scientific partnership with key investigators in assigned TA, academic institutions and scientific societies.
  • Advanced medical/scientific writing and communication skills.
  • Strong track record of collaboration in a matrix environment.
  • Fluent English (Oral and Written).

Skills:

• Agility.
• Clinical Development.
• Clinical Practices.
• Cross-Functional Collaboration.
• Data Analysis.
• Health Sciences.
• Healthcare Sector Understanding.
• Influencing Skills.
• Innovation.
• Integrated Evidence Generation.
• Medical Affairs.
• Medical Communication.
• Medical Education.
• Patient Care.
• Priority Disease Areas Expertise.
• Product Launches.
• Product Strategy.
• Real-World Evidence (RWE).

Skills Desired:
Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies.#J-18808-Ljbffr