Senior Director, Clinical Operations, Hemavant

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

Hemavant is an incubating private biotech company within the Roivant Sciences company portfolio. Hemavant is dedicated to developing novel targeted therapeutics to improve the lives of patients with blood disorders and hematological malignancies.  Hemavant will leverage novel biology and cellular dependencies to identify transformative therapies. Hemavant is headquartered in Basel, Switzerland with offices in New York City, US.

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 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. Traditionally, Roivant provides all the capital required for Vant operations until the Vant becomes a public company. Roivant attracts, retains, and motivates entrepreneurial company builders that have deep domain expertise with competitive compensation and benefits, including stock option grants and terms comparable to venture-backed, pre-IPO biopharma companies.

Position Overview

The Senior Director of Clinical Operations will play a key role in advancing the clinical development of programs across the Hemavant current and future portfolio. They will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission. This individual will drive the successful execution and timelines for clinical trials and programs drawing on a high level of expertise with clinical and regulatory requirements for clinical operational processes and requirements. They 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
  • Represent the clinical operations program on strategic governance bodies (e.g., Safety Team, Project Team, etc.)
  • 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

  • Bachelor's Degree in a scientific discipline; advanced degree preferred;
  • 10 – 15+ years of clinical operations management experience, including trial leadership experience
  • 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
  • Highly analytical, scientific mind with exceptional problem-solving skills
  • Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
  • Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy
  • Strong communication and presentation skills 

Hemavant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.

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