SSO Portfolio Team Lead (Remote)

Job Description

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO

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 milestones, 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 responsibilities include, but are not limited to:
• 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.
• 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.
• Ensures Country study site selection, activation, enrollment, data flow and timeline commitments are delivered and reported per established study milestones and Country commitments.
• Collaborates with the SSO Site Partnership Manager and relevant medical/clinical functions to enhance Novartis relationship with clinical sites, to ensure optimal site relationship management and delivery on study commitments.
• 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.
• Manages CPM and SSO Feasibility Manager adherence/compliance to SOPs and required training curricula
• Supports CO/site audits and inspections (as appropriate) related to CAPA follow-up and implementation of study level identified issues
• 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.
• Ensures CPMs and SSO Feasibility Managers have the required level of project management and therapeutic area knowledge and skills to successfully deliver study and protocol requirements
• Is responsible for managing and addressing CPM performance targets per defined key trial milestones (including country/OPC country trial commitment), and serves as an escalation of study issue resolution in collaboration with the CRA Managers and their CRAs
• Ensures country study budgets (Trial Commitment Forms, TCFs) are managed per established study key performance indicators and study objectives
• Ensures study milestones to allow timely payments to stakeholders (invoiceable items and vendors) for clinical trial activities

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you’ll bring to the role:
• A degree in scientific or health discipline required and advanced degree with experience in project management, is preferrable
• Fluent in both written and spoken English
• 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)
• Communicate effectively in a local/global matrixed environment

#GCO

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

US 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 send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

The pay range for this position at commencement of employment is expected to be between $201,600 and $302,400 annually; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.