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; 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.

Position Summary

Roivant is seeking a Vice President, Clinical Operations to play a key role in delivering high quality clinical results across multiple indications for a strategically important program. The individual in this position will have the unique opportunity to grow and shape the clinical team at a rapidly growing biotechnology company. This position will contribute to the Vant’s success by managing the clinical operations activities while working closely with other functional area leads and third-party CROs and vendors.

He/She will provide strategic and operational leadership across multiple clinical programs including clinical operations strategy, risk management, and compliance with regulatory guidelines. This role will ensure that corporate objectives are met to specification, identifying, and resolving program/cross-program level issues and risks, and maintaining process and quality expectations.

Responsibilities

Cross-indication management of clinical trials including scope, timelines, quality, risk management, and budgets with adequate governance processes.
Serve as the point of contact for senior management and Operations Leads including preparation of clinical content for the Board of Directors meetings and financial disclosures.
Participate in developing the overarching strategy for the Clinical Development and Operations including Sponsor Oversight and Governance for key CROs and other vendors.
Develop and implement enterprise-level standardizations where appropriate, while retaining a level of flexibility that allows for speed of execution and creative innovations.
Participate in developing and managing the long-range plan for the Clinical Development and Operations that anticipates future needs (resources and technology) and maximizes the team’s ability to work efficiently while delivering high quality, customer-focused solutions.
Own all aspects of the Quality System related to the Neruoscience Clinical Operations with Quality Unit oversight including drafting and maintaining SOPs, and driving quality improvements.
Actively monitor progress on the functional-level scorecard that aligns to the R&D research goals and priorities including leading indicator metrics that monitor results against the approved plan.
Develop the resourcing strategy for the function including management of hiring, performance management and succession planning of direct reports. Also, build relationships with our external partners to supplement internal staffing.
Ensure effective external partnerships with study sites, investigators, KOLs, pharma trade associations, and alliance partnerships.
Cultivate effective relationships with health authorities to ensure the successful outcomes of inspections.

Skills, Qualifications, And Requirements

Bachelor’s degree or higher within life sciences plus a minimum of 10 years Clinical Operations Management in Pharmaceutical/Biotech industry
Proven record of implementing Project Management processes, methodologies, practices and infrastructure, as related to the Biopharmaceutical Industry
Proven project management experience in the planning, conduct and management of clinical programs (Phase I-post-marketing)
Demonstrated ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
In depth knowledge of Drug Development with strong understanding of other functions relevant to the position which include: Nonclinical, Manufacturing, Commercial and Regulatory
Direct experience in managing projects to registration and launch
Experience interfacing with regulatory agencies (e.g., FDA, EMA)
Previous supervisory and leadership experience
In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
Demonstrated organizational and planning skills and independent decision-making ability
Strong organization and time management skills and ability to effectively manage multiple competing priorities
Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, Project)
Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
Demonstrated communication, problem-solving, and negotiation/decision-making skill
Ability to think outside of the box and challenge the status quo
Natural entrepreneurial spirit with unrelenting dedication to delivering results
Desire to work in a fast-paced, innovative environment
Natural collaborator who enjoys working on a cross-functional team
Knowledge of GDPR a strong plus
Strong analytical and organizational skills
Excellent written, verbal and interpersonal communication skills
Ability to professionally interface with senior-level executives, staff, external partners and consultants
Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
Ability to take initiative, prioritize and execute tasks and special projects with minimal direction or supervision, maintaining a high-level of confidentiality, integrity and discretion at all times
Travel requirements: approximately 30% (both national and international)

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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