The Executive Director / Head of Evidence Generation Excellence is a senior leadership role responsible for the operational oversight of medical affairs processes within US Medical Affairs. This position ensures the efficient, compliant, and innovative execution of the evidence generation portfolio, including clinical trials, HEOR studies, and other medical operations. The role is pivotal in driving operational excellence, fostering cross-functional collaboration, and upholding the highest standards of review and compliance.

Key Responsibilities:

Central Review/Compliance (IITs, RCs, HEOR/IS studies): 

• Responsible for providing US research portfolio oversight and partners with medical leadership to review/approve new and ongoing USMA priority programs. 

Drug Supply Management: 

• Provides oversight of US drug supply for all USMA programs. 

Governance: 

• Responsible for CIA Governance teams, partnering with ERC, legal, Medical SMEs to address CIA requirements and inquiries. 
• Oversees and supports audits conducted within the organization, including driving corrective action plans. 

Operational Efficiency/Process Excellence: 

• Designs and drives novel simplified and innovative optimization strategies that improve efficiencies. 
• Critically analyzes core components of USMA processes and establish continues process improvement/implementation across programs. 
• Develops and manages strategy and processes to improve and measure operational effectiveness and procedural accuracy in US Medical Affairs. 

Systems Management/Oversight/Metrics: 

• Oversees all clinical operation systems and tools (e.g., GEMS, HORIZON, SUBWAY, reports, enhancements, process steps, etc.). 

Contracts/Business Solutions: 

• Provides medical operational services to business partners across Novartis divisions; including alignment of operational business requirements, clinical trial start-up (SSU) innovation, vendor intelligence, innovative strategic sourcing expertise, productivity, and risk mitigation. 

Team Leadership/People Management: 

• Provides effective coaching and development to team members to build technical and leadership skills in line with Novartis Leadership aspiration. 

​Minimum Requirements:

Work Experience:

• Minimum 20 years clinical research experience that provides the required knowledge, skills and abilities and experience mentoring or training others. 
• Minimum 5 years people management experience including hiring, performance management, and inspirational leadership. 
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures including industry compliance and ethical requirements. 
• Ability to utilize problem-solving techniques applicable to constantly changing environment. 
• Demonstrated track record of managing cross functional projects. 
• Strong Influencing, Instigator, and Integrator Skills/Capabilities. 
• Demonstrated ability to effectively interact and work collaboratively with multiple cross functional teams.  

Education:

• Advance degree in a science related field or equivalent certification/licensure from an appropriately accredited institution.

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between $225,400 and $418,600 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.