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 and 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; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched 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.
The Head of Clinical Operations will be responsible for establishing the clinical operations function for an incubating portfolio company (Vant) focused on development of first- and best- in class treatments in pulmonary diseases. S/he will lead and oversee execution of clinical programs to progress programs forward within the portfolio. S/he will proactively identify and mitigate risks, lead from the front and collaborate with the CMO and VP of Program Management to improve timelines and budgeting for the pipeline. This is an opportunity to play an instrumental role in bringing a novel therapy to market with blockbuster commercial potential while providing better treatment options for patients.
- 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 quality and data integrity
- Responsible for the successful planning and execution of Phase 2 and 3 trials
- Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement.
- Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
- Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs.
- 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 late-stage development experience
- Develops and optimizes critical SOPs needed for program success and compliance.
- Serve as Clinical Operations point of contact for portfolio planning and business development opportunities
- 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
- Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
- Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
- Create and oversee clinical program budget(s) and long-range clinical 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
- Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience.
- Extensive clinical operations management experience, including program leadership or TA leadership at a minimum.
- Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously. Experience in Respiratory/Pulmonary diseases preferred.
- Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
- 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
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy. Strong coaching and mentoring skills leading to the success and development of subordinates
- Willingness to work across all levels to support Clinical Operations success.
- 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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