Head of Clinical Operations

Location: Roivant Sciences, Inc., 151 West 42nd Street, 15th Floor, New York, NY 10036

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:  launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019.  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 first large 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. 

Position Summary: 

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.  This individual must be self-motivated and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate.

Responsibilities:

  • 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

Requirements:

  • Bachelor's Degree in a scientific discipline; advanced degree preferred; PMP Certification strongly preferred
  • 10 – 15+ years of clinical operations management experience, including trial leadership experience
  • Experience managing CROs required
  • Experience developing clinical study protocols in conjunction with a study team required
  • Managing clinical trial staff experience preferred
  • Early and late phase investigational product development experience preferred
  • 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
  • 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 communication and presentation skills

 

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