Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients ad their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; 10 consecutive positive phase 3 trials; 6 FDA approvals; >10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic areas; successful commercial launch of VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) working hand in hand with Business Development to establish the scientific rationale and creating/underwriting a development strategy for in-licensing opportunities, with a focus on oncology, immunology and rare diseases; 2) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
To learn more about our story and company culture, please visit us at https://roivant.com/
Position Summary:
The Vice President of Clinical Operations will play a key role in advancing the clinical development of programs across the Roivant portfolio and supporting the launch of newly created biotech subsidiaries (Vants) across a diverse range of therapeutic areas. This person, together with the Clinical Operations team, will establish and execute innovative and expedient program/trial execution strategies and priorities in alignment with company goals and in collaboration with the cross functional teams within and outside R&D. This individual must be highly self-motivated, optimization-minded, and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate, with a deep sense of personal ownership of deliverables. They will also need to have excellent communication skills across diverse audiences, including executive leadership within Roivant and vants, technical, business, and operational groups, and with contract research organizations and vendors. They need to enroll trials expeditiously across disease areas with high data quality through their own work and that of their team.
Key Responsibilities:
- Leadership responsibility for Clinical Operations strategy, initiation and execution of clinical trials across all phases, including (but not limited to) CRO/vendor selection, site engagement, contracts & budgets, CRO oversight, and proactive risk management to ensure the quality conduct of trials with a high level of data integrity
- Provide excellent direct line management and training/mentoring of Clinical Operations team members, creating a nimble, versatile, world-class, high performing operations team
- Scoping geographic region and site specific approaches with substantial experience in global clinical trial execution for successful incubation of trials during diligence and launch post transaction is highly critical
- Demonstrate leadership in preemptively identify and develop outlines of indication- and phase-specific operations plan before and during diligence to arrive at the most realistic estimates of enrolment and data availability timelines in the integrated development plan underwritten in the Investment Thesis
- Work cross functionally to drive the strategy and own implementation for clinical programs and manage the integrated development plans to deliver against company goals
- Lead and supervise all aspects of study progress from concept to close-out to assure adherence to Good Clinical Practice, intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines;
- Serve as Clinical Operations point of contact for strategic governance bodies (e.g., Safety Team, Project Team), as well as portfolio planning and business development opportunities
- Lead Clinical Study teams in gathering and reporting key study data collection and presentation to use in support of regulatory filings, as well as project team and management communications
- Oversee identification, qualification and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
- Establish governance procedures for CROs and key clinical vendors ensuring continuous performance oversight and process improvement
- Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
- Liaise effectively with vant staff, including management and execution team
- Provide scientific/clinical expertise in the design and interpretation of clinical studies
- Build and implement repeatable and scalable approaches to enrollment projections, geostrategy and patient enrollment essential for future vant planning and execution
- Implement novel technologies, platforms, tools to improve and scale core capabilities such as enrollment projections, geostrategy and patient enrollment essential for future vant planning and execution
- Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
Requirements:
- Bachelor's Degree in a scientific discipline; advanced degree preferred
- 15+ years of clinical operations management experience, including trial leadership experience
- Experience managing CROs and key clinical vendors required
- Experience developing clinical study protocols in conjunction with a study team required
- Track record leading clinical operations teams to deliver on time execution and results, including outsourced support
- Early and late phase investigational product development experience required
- Demonstrated ability to set and prioritize goals and objectives; excellent time management, negotiation, problem-solving and organizational skills
- Proven excellence in clinical operations strategy including simultaneous oversight of multiple trials, and ideally experience managing multiple vendors in dispersed project team environments
- Experience in building infrastructure (including SOPs) required
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
- Entrepreneurial mindset, bringing in creative ideas to challenge the status quo of clinical trial execution
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
- Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy
- Strong communication and presentation skills
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.
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