Senior Medical Affairs leader responsible for the development and implementation of the strategy and plan of the Global Medical Affairs program(s) for a specific disease area under the leadership of the respective GMA Franchise Head. Leads a team of Global Medical/Scientific Directors who work directly on the specific compounds and programs within assigned disease area.
Leader of cross functional IDMT and core member within GPT and IDAPS to lead the development of an integrated medical affairs strategy and plan encompassing complementation of the registration, preparation for launches and life cycle management plans for the assigned disease area.
Accountable to efficiently manage budgets and resources, including budget planning for future activities within assigned disease area.
Leads strategic discussion and gains alignment across regions and functions, through generation and successful implementation of IDAPS.
Accountable for all operational aspects and drives execution of Global Medical Affairs clinical trials in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates.
Accountable for ensuring Medical leadership to CTT s for Novartis sponsored GMA trials.
Accountable prioritization and review of investigator-initiated trials and Local/Regional NVS sponsored Medical Affairs trials for assigned product(s).
Provides medical oversight for educational events (e.g. stand-alone meetings, scientific symposia) and scientific congresses within legal and compliance regulations.
Responsible and accountable for review and approval of key scientific communications, medical information documents and commercial documents within P3 legal and compliance regulations.
Provides medical input on overall publication strategy and is a key member of publication planning team providing GMA medical input on individual publication plans.
Provides medical leadership in interactions with key external stakeholders e.g., leads advisory boards.
Ensures career development of functional reports as well as other GMA colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of ICT members as appropriate.
Accountable for developing clinical components of key documents regulatory & safety from GMA studies supporting submissions and post-marketing commitments to HA s, when applicable.
Deliver on product strategy through execution of clinical trials, scientific communications and medical information based on medical plan.
Development of external/internal insights to drive innovative medical plans.
People and talent management.
Effective use of budget and resources in delivering high-quality Medical Affairs program.
Direct reports: 3-5
Overall lifetime clinical budget for respective disease area. Forecast and management of budget and adherence to targets
Effective interaction with key external stakeholders, and decision makers (regulatory authorities, medical experts, pricing and reimbursement bodies).
Optimized value proposition of disease area portfolio throughout the life cycle.
Effective management of a broad range of MA programs including management of budget and resources.
Strong alignment between Global and Regional / local medical affairs organizations.
Strong alignment within Brand team and within GPT.
Delivery of high quality reporting of clinical trials and robust educational programs for external and internal.
Recruitment and development of talent to achieve a high performing organization.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education (minimum/desirable): MD required for GGMD role, GGSD requires advanced life sciences degree (PharmD, PhD, etc.)
More than 10 years advanced knowledge in medical/scientific area. Oncology, Hematology, Endocrinology) required.
Fluency in written and spoken English
Technical / Functional Skills
Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting). Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area.
Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products.
Effectively engage external stakeholders across a broad range of audiences and activities.
5 years of experience in pharma at local, regional and/or global level.
Excellent communication skills, fluent in English
Operational / Executional Skills
Can effectively manage and optimize resources and budget to meet business needs; have excellent project management skills.
Provide medical expertise to ensure successful product launches across functions.
Lead and manage different activities:
NVS sponsored trials,
Review and coordinate IITs
Implement patient access programs.
Review promotional materials
Provide training to external and internal customers.
Define publication strategy and contribute to publication planning
People & Relationships
Build and lead high performing cross-functional teams collaboratively; effectively use rewards and recognition to create a culture of engagement and inclusion.
Acquire, develop, and retain exceptional talent.
Display a passion for building talent pipeline; provide feedback and coaching to team members on an ongoing basis.
Expertly lead and manage large, cross-functional, global teams to achieve high performance.
Build strong internal and external relationships with diverse stakeholders that maximize alignment and organizational effectiveness.
Can effectively manage different and diverse projects (clinical program, publication, medical education, Advisory boards).
Effectively develop, communicate, and drive a long term vision and plan for medical affairs program, anticipating and addressing potential issues.
Display enterprise leadership in all aspects of the role by gaining alignment across functions and divisions.
Integrate medical expertise with commercial perspective.
Expertly manage ambiguity and highly complex situations.
Maintain an external focus to optimize and maximize treatment options and compound life cycle management.
Have excellent communications skills and ability to convey complex scientific and clinical concepts simply and effectively.
5 years of experience in pharma, with minimum of 3 years in medical affairs in regional or global level
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