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Strategic Feasibility Expert

$204.4k - $379.6k

U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.

Band Level 5 Job Description Summary Position Location: Cambridge, MA #LI-hybrid. This role is based in Cambridge, MA. Please apply only if this location is accessible for you. Role Overview Oversees all operational aspects of clinical trials end-to-end, including planning, execution, interpretation of clinical trial research, data collection activities, and clinical operations. Provides complete oversight of budget and resource allocation within the assigned trial, drives operational excellence through process improvement and knowledge sharing across trials within the program or franchise, and enables an empowered organization capable of navigating a matrix environment and adjusting quickly to business needs. Acts as the point of escalation for resolution of trial management operational issues. Applicable to Clinical Scientific Expert Group Head The CSE Group Head (CSE GH) supervises Clinical Scientific Experts (CSE I/ CSE II) and is responsible for competency building of the team by coaching the Clinical Scientific Expert. The CSE GH facilitates allocation across Development Programs/Brands for planning and tracking all activities pertaining to one or more Development Programs or Brands. Responsible for allocating/balancing resources in alignment 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. Major Accountabilities Provides early, strategic feasibility input (including early medical and operational feasibility) for a given therapeutic area, 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 or 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 or sites. Maintains knowledge of investigators and sites mapping in alignment with TA/indication strategy. Maintains awareness of site performance data such as recruitment, time to contract, and master agreements (MSAs). Identifies and maintains relationships with 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 the 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 or advises patient recruitment strategy, enrollment 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 the 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 a team member. Leads cross‑functional process improvement initiatives and develops best practices for feasibility and site selection activities. Role 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. Compensation and Benefits The salary for this position is expected to range between $204,400 and $379,600 per year. The final salary offered is determined based on factors such as relevant skills and experience, and upon joining Novartis it will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance‑based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US‑based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time‑off package including vacation, personal days, holidays and other leaves. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. 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 strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e‑mail to View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #J-18808-Ljbffr U175 (FCRS = US175) Novartis Institutes for BioMedical Research, Inc.

Vacancy posted 2 days ago
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