About the role
The SSO Portfolio Team Lead is responsible for the Clinical Project Managers (CPMs) and SSO Feasibility Managers and their study specific activities, including the hiring, training, development, and assignment to ensure adequate and timely portfolio execution. The SSO Portfolio Team Lead assures that CPMs coordinate their activities across all CRAs working on the same trials/projects in collaboration with the CRA Managers/FSP line managers.
The SSO Portfolio Team Lead is responsible for CPMs and SSO Feasibility Managers compliance of study management activities and for the delivery of study achievements, in close collaboration with the CRA Managers/ FSP line managers and aligned with Global and local medical strategy, in the country structure. The Portfolio Team Lead is responsible for overall portfolio execution related performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP’s, and local regulations.
Your Key Responsibilities:
Portfolio Execution strategy
• Collaborates with Country Head, Country Portfolio Head and CRA Managers/FSP line managers to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Portfolio Execution country leadership
• Identifies and leads innovative solutions to further advance the Project Management in GDD portfolio, in collaboration with Study & Site Operations country leadership
• Supports the Country Portfolio Head in implementation of the global strategy within the country structure (incl. escalation & risk mitigation, as well as study allocation to CPMs)
Allocation, initiation and conduct of trials
• Develops opportunities in collaboration with SSO Feasibility Manager, Country Portfolio Head and relevant medical/clinical functions to build a competitive advantage for GDD trials within the country, ensuring alignment with the local medical standard of care, local business drivers and site relationship management
• Ensures that SSO Feasibility Managers provide comprehensive proposals and timelines for country allocation, including early identification of risk and opportunities for the clinical program/trial
• Operationally supports allocation of new trials in collaboration with Study & Site Operations Country leadership, during trial feasibility/allocation
Delivery of quality data and compliance to quality standards
• Collaborates with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
• Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated.
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Management of people and resources management
• Is responsible for the hiring, training, development, and retention of a team of Clinical Project Managers (CPMs) and SSO Feasibility Managers to ensure study milestones are delivered for the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Together with the country Portfolio Head performs ongoing assessment and allocation of CPMs, and SSO Feasibility Manager resources within Country and Hub to ensure balanced workload
EEO Statement
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
Role Requirements
• Minimum 8 years’ experience in clinical research and/or project management and evidence of team management and leadership capabilities; 4 years of people management experience
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent project management capabilities with demonstrated capability to problem solving and mediate complex compliance issues
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining
to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $201,600 – $302,400/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 f