Director, Clinical Business Operations

Reports To: Senior Director, Clinical Business Operations (Trial Support/SOP and Process Improvement )

Location: Remote

 

Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. The Company’s investigational product, batoclimab, is a fully human, monoclonal antibody that targets and binds to the neonatal Fc receptor (FcRn).

 

The Role:

This position is responsible for leading major initiatives across the clinical operations organization at Immunovant. They will create, drive, and improve businesses processes that are innovative in their approach to drug development and compliant with global regulations and financial obligations. This person will also support a broad range of ad hoc clinical operations projects for Immunovant.

 

Key Responsibilities: 

Trial Support

  • Liaise with legal to review and update contract templates, including the strategy around use of MCTAs and any ancillary agreements for Clinical Operations
  • In collaboration with the Clinical Operations Lead, liaise with the CROs to develop contract execution strategy
  • Conduct assessment on study-level budgets at the time of development and provide any guidance on adjustments to the Clinical Operations Leads.  Provide oversight and management of internal personnel responsible for site budget and contract reviews across indications
  • Liaise with Legal team on contract negotiation trends and manage CRO contract playbook
  • Oversee fair market value assessments for budget line items and perform cost analysis of site budget trends by country and study level.
  • Periodically review investigator payments from the CRO to ensure that investigator grants are made in accordance with executed contracts and in alignment with Immunovants expectations
  • Collaborate with Finance team to provide insights on investigator grant accruals and provide support on forecasting trial level investigator grant costs

SOP and Process Improvement 

  • Develop and manage the clinical organization’s SOPs and partner with subject-matter experts to modify and improve upon existing SOPs when required.​
  • Provide project management support to cross functional team members in development of other departmental SOPs
  • Lead Quality Steering Committee Meetings, in collaboration with Quality organization
  • Develop and implement training from new processes / process improvements
  • Drive and support inspection-readiness across the clinical organization by collaborating with Clinical Quality, promoting excellence in execution and training compliance in the Quality Management System, developing tools to support teams, creating reports with KPIs and providing recommendations and implementing applicable remediation tactics.​
  • Provide support for internal audits by serving as the Clinical Subject Matter Expert and manage any CAPA/Process improvements that come out of internal audits
  • Review SOPs, training documentation resulting from new process roll out to determine effectiveness
  • Provide support in the development of onboarding and training -related needs within the clinical operations organization

Both

  • Lead and drive operational excellence initiatives within the clinical operations organization, including the creation and delivery of tools, processes, templates, training, and guidance to drive efficiency, compliance, and best practices, while ensuring quality is integrated into the processes​
  • Host periodic meetings with Clinical Operations Leads, Sr/CTMs and CTAs to share lessons-learned, better understand internal/external best practices and escalate recommendations for process improvements for vetting/implementation
  • Collaborate with internal and external stakeholders to optimize cross functional synergies and improvements
  • Build collaborative relationships with key internal stakeholders

 Requirements:

  • Bachelor’s degree required
  • Minimum of 12 years progressive experience in clinical or business operations with thorough understanding of cross functional clinical processes including clinical trial operations, clinical supply, data management, biostatistics, and medical writing
  • Experience in project management is required
  • Direct supervisory experience is required
  • Deep experience and expertise in the conduct and execution of end-to-end global clinical trials, including process and experience within one or more key functions is required
  • Experience in working with and managing CROs is preferred
  • Working knowledge of clinical trial systems (CTMS, IRT, EDC, eTMF) preferred
  • Experience in training and process improvement preferred

 Experience:

  • Experience in managing cross functional team members during trial execution
  • Strong knowledge in GCP and ICH and of the application process to conduct clinical trials
  • Ability to function in a fast pace, dynamic environment
  • Ability to deal with ambiguity
  • Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
  • Strong interpersonal and negotiation skills
  • Proven complex problem solving and decision-making skills
  • Must be a demonstrated self-starter and team player with strong interpersonal and communication skills
  • Excellent written and verbal skills
  • Must display strong analytical and problem-solving skills
  • Must be able to travel

 

Work Environment:

  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Remote based, will have access to Immunovant’s NY /  NC offices
  • Domestic travel may be required (up to 10%)

 

Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $190,000.00 - $225,000.00.

 

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