Strategic Feasibility Expert

Novartis • Cambridge, MA

3d • $204,400 - $379,600 • Hybrid

About The Position

Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial. Applicable to Clinical Scientific Expert Group Head: The CSE Group Head (CSE GH) supervises Clinical scientific experts (CSE I/ CSE II). Responsible for competency building of the team by coaching the Clinical Scientific Expert. The CSE GH facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands. Responsible for allocating/ balancing resources aligning with Clinical Development Functional Heads (CD-FH), Global Program Clinical Heads (GPCH), Therapeutic Areas Heads (TA Heads) and based on the Development Unit/portfolio needs.

Requirements

• Bachelor’s degree required; Master’s degree or equivalent preferred
• Degree in Science, Medicine, or Business strongly preferred
• Minimum of 8–10 years of experience in the pharmaceutical, biotechnology, or CRO drug development environment
• Strong understanding of the drug development process, with preference for early clinical development experience
• In-depth knowledge of clinical trial site selection, including global and country-specific requirements, timelines, and execution challenges
• Demonstrated expertise in project management, with strong analytical and problem-solving capabilities
• Excellent oral and written communication skills, including the ability to convey complex information clearly
• Proven ability to work effectively within a global, matrix organization and to build strong, positive working relationships
• Strong customer and team orientation; collaborative team player with excellent interpersonal skills
• Advanced computer literacy
• Strong organizational skills with the ability to manage multiple priorities, respond to shifting demands, and handle unexpected events while maintaining a positive and professional attitude
• Ability to work independently, with a demonstrated willingness to make decisions and take accountability
• Excellent influencing and negotiation skills

Nice To Haves

• Budget Management
• Clinical Research
• Clinical Trial Protocols
• Clinical Trials
• Coaching
• Cross-Functional Teamwork
• Data Analysis
• Learning Design
• Lifesciences (Inactive)
• Risk Management
• Risk Monitoring

Responsibilities

• Provides early, strategic feasibility input (including early medical and operational feasibility) for a given therapeutic area (TA), indication, or study, through the utilization of relevant tools, databases, and historical metrics.
• Accountable within the CTT for appropriate site identification and anticipating and relaying hurdles/delays for consideration in ultimate selection and timelines.
• Consolidates feasibility feedback and potential site list for CTT decision making.
• May act as the point of escalation when a site selection or sourcing challenge is identified which can impact the trial timelines.
• Engages internally and externally to identify new investigators /sites.
• Maintains knowledge of investigators /sites mapping in alignment with TA /indication strategy.
• Maintains awareness of site performance data e.g. recruitment, time to contract, master agreements (MSAs).
• Identifies and maintains relationships with key strategic key strategic investigators, sites, and networks for a given indication, program, or TA.
• Identifies and establishes strategic partnerships as appropriate.
• Initiates and ensures confidentiality disclosure agreements (CDAs) and consultancy agreements (CSAs) for assigned TA, according to ethics and compliance standards and to team timelines.
• Works closely with the CTT during protocol development to understand site specifications and to provide robust input into the study operational plan.
• Works closely with the Clinical Finance Manager (CFM) to provide input to site budget, timelines, and TTG impact.
• Requests Grant Plan.
• Conducts /advises patient recruitment strategy, enrolment projections and scenario modeling in order to improve the reliability of forecasting at trial, country and/or site level.
• Maintains awareness of country related impacts on recruitment and budget to help guide clinical trial global footprint and optimize most effective recruitment.
• May work in close collaboration with the Global Development Operations-Trial Monitoring Organization (GDO-TMO), ensuring a timely handover of the strategic feasibility information package for the site-specific operational feasibility.
• Organizes regular TA portfolio reviews for early planning and communication.
• Liaises with other line functions, e.g., Early Regulatory Affairs, Patient Engagement & Advocacy, for alignment and input into feasibility considerations.
• Participates in assigned TA Milestone monthly meetings and CTT study planning meetings (from kick-off to all sites contracted) as team member.
• Lead cross-functional process improvement initiatives and develop best practices for feasibility and site selection activities.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior