At Roivant, we are passionate about discovering and developing new drugs to impact patients' lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world's leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
The Head 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 will establish program and trial execution strategies and priorities in alignment with company goals and in collaboration with the CMO and Head of Program Management. This individual must be self-motivated and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate.
- Responsible for clinical operations strategy, initiation and execution of clinical trials, including (but not limited to) CRO selection, contracts & budgets, CRO oversight, and proactive risk management to ensure the quality conduct of trials with a high level of data integrity
- Work cross functionally to drive the strategy and oversee 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 intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; Heavy emphasis on early stage experience
- Serve as Clinical Operations point of contact for portfolio planning and business development opportunities
- Lead Clinical Study teams in gathering and reporting key study data in support of regulatory filings
- Represent the clinical operations program on strategic governance bodies (e.g., Safety Team, Project Team, etc.)
- 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
- Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
- Provide scientific/clinical expertise in the design and interpretation of clinical studies
- Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
- Provide direct line management and training/mentoring of Clinical Operations team members
- Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
- Create and oversee program budget(s) and long-range planning/forecasting activities
- Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
- Contribute as required to the authoring of key regulatory documents, study protocols, investigator's brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
- Participate in business development and process improvement/quality initiatives, as needed
Skills, Qualifications, and Requirements
- 15+ years of experience in clinical research and/or clinical trial operations in Biotech, Pharma or CRO, and a minimum of 5+ years in a supervisory role managing clinical operations staff.
- BA/BS in life sciences or healthcare field required; Advanced degree (Pharm D, Ph.D.) preferred.
- Thorough knowledge of GCP, ICH guidelines, US and international clinical regulatory requirements.
- Excellent track record of effective performance in cross-functional environment, including successful relationships with data management, biostatistics, medical writing, and regulatory affairs.
- People management and team motivation skills to motivate staff and cultivate quality processes.
- Experience in execution of complex clinical trials, including experience ranging from small Phase 2a studies to large multi-center global Phase 3 programs.
- Well versed in ICH/GCP and applicable FDA/EMA regulations required
- Recognized leader with demonstrated operational excellence, innovative thinking and scientific mindset.
- Demonstrated ability to develop and implement business strategies across multiple disciplines and proven success leading change/transformational efforts.
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.