Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant advances its pipeline by creating nimble subsidiaries or Vants to develop and commercialize medicines and technologies. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 11 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms. In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. To learn more about our story and company culture, please visit us at Launch your career at the intersection of science and strategy. Join a 2-year, hands-on Clinical Operations Fellowship designed for leaders eager to shape the future of drug development. Work side-by-side with seasoned clinical leaders on active trials across Roivant's portfolio, gaining deep exposure to study execution, regulatory frameworks, cross-functional collaboration, and global operations. Why Clinical Operations: Clinical Operations is where science meets strategy and clinical operations leaders are the front line for successful clinical trial execution. With increased development costs, trial complexity, and competition for sites and study participants, clinical operations plays a pivotal strategic role in enabling successful clinical research. By ensuring that complex trials are executed efficiently, compliantly, and on budget they can accelerate the path from development to market and drive meaningful value creation for biopharmaceutical companies. However, costly delays remain pervasive: industry estimates indicate that roughly80% of clinical trials fail to meet their initial targets and timelines, and more than 20% of participants who enroll in a study won't see it through to completion. These delays are often attributed to preventable operational issues - underperforming sites, missed enrollment milestones, poor protocol design/development, or a lack of operational set-up/support for participants. Nimble, strategic clinical operations leaders avoid costly delays, accelerate trial timelines, and ensure that safe and effective therapies are delivered to participants while preserving the ROI. The Clinical Operations Fellowship is a two-year, hands-on leadership development program designed for those ready to do more-faster, with quality. This isn't an observe and learn program-it's a launchpad. You'll gain direct operational experience, a powerful network, and the opportunity to help shape the future of clinical operations excellence and innovation. Come ready to lead, build, and make an impact from day one. As a Clinical Operations Fellow, you will:
- Own impact: Apply your intellect to drive operational excellence in timelines, budgets, and site engagement
- Build Key Relationships: with KOLS, PIs, site research teams, and advocacy groups
- Lead from day one: Collaborate with Clinical Development and Operations Teams, Site Leads, and external partners to deliver high-quality trials on time and on budget
- Think globally: Learn ICH-GCP standards and navigate regulatory pathways with confidence
- Develop as a leader: Access executive mentorship and build a fast track towards R&D and broader operational leadership roles
Responsibilities: Trial Set-up and Oversight:
- Initiation and execution of clinical trials, including (but not limited to) CRO/vendor selection and setup, site strategy, contracts & budgets, CRO/vendor oversight, system integration (eTMF, EDC, CTMS, IRT, etc), tool, template, and process development, and proactive risk management
- Involvement in study/program budget development, resource allocation, and long-range planning
- Lead and supervise all aspects of study progress to meet intended timelines and achievement of study and corporate goals while ensuring quality in accordance with regulatory guidelines
- Leverage and optimize skills and resources, working with internal and external stakeholders, to ensure program success
- Collaborate in design and implementation of clinical protocols, clinical data collection, and quality management
- Collaborate on clinical documents (e.g., Investigator Brochures, IND annual updates, safety reports, protocols, clinical study reports, informed consents, etc.)
- Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
- Provide operational input on overall product development planning in coordination with the development team
- Drive patient recruitment and retention strategies to meet or exceed enrollment targets
- Partner closely with Regulatory to align clinical trial timelines and site activation with overall submission strategies
- Participate in decisions on data analysis and data presentation in order to fulfill corporate needs
- Participate in business development and process improvement/quality initiatives, as needed
Relationship Management:
- Develop and maintain strong, collaborative relationships with vendors, CROs, and other external partners in support of timely clinical trial execution
- Build and maintain professional relationships with KOLs/HCPs, sites and site personnel in alignment with clinical development strategy and timelines
- Provide support for activities including but not limited to site identification, qualification, and selection, site initiation visits, study team training, medical congresses, and advisory boards
- Collaborate effectively with the members of the cross-function project teams
Skills, Qualifications, and Requirements:
- Advanced degree (MD, PhD, or PharmD required)
- 2+ years of management consulting experience preferred
- Intellectually curious, execution-driven, and relentlessly resourceful
- Strong communication, analytical thinking, and a bias toward action
- Interest in strategy, clinical development, and biotech innovation
- Demonstrated force of will
- Self-starter with a strong sense of ownership and ability to work autonomously
- Desire to work in a lean, fast-paced, nimble environment; comfort with associated uncertainty and rolling up your sleeves to get things done
- Willingness to travel
Base salary for this role will be determined during the interview process and will vary based on multiple factors, including but not limited to prior experience, relevant expertise, current business needs, and market conditions. The expected base salary for the role will generally be between $135,000 - $150,000 per year at the commencement of employment, but the final salary offered may be outside this range based on individual circumstances and business and market conditions. Base salary if hired is only part of the total compensation package, which, depending on the position, may also include other components such as discretionary bonuses, equity, and Company-sponsored benefit programs. This position is at-will and Roivant 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 and business and market conditions. Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!