Vice President, Translational Science and Clinical Laboratories

Job Description

About the Role

Title: Vice President, Translational Science and Clinical Laboratories

Location: Remote

Job Description:

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

The VP, Translational Science, and Clinical Laboratories leader is part of Immunovant’s Senior Leadership team and is responsible for serving as Immunovant’s in-house expert on the role of FcRN biology in autoimmune diseases and also leads Immunovant’s clinical laboratory team.

Key Responsibilities:

Lead a team of clinical laboratory leaders and scientists for biomarker method development, validation, and sample analysis in a regulated environment (GLP or CLIA).

Drive Nonclinical and translational science guiding programs by articulating a deep understanding of the underlying immunobiology and leading the development of a research agenda.

Lead the development and execution of research studies that further the understanding of the role of Immunovant’s investigational therapies in autoimmune disease.

Partner with Nonclinical, Toxicology, Clinical, and other stakeholders on the design of development plans, including clinical trial protocol development and the selection of bio-analytical assays

Ensure efficient business processes and high-quality laboratory procedures and documentation for GLP / CLIA compliance.

Ensure development teams understand the costs of testing and advocate for team decisions that would lead to a positive site and patient experience.

Lead contract laboratory workstreams for all clinical laboratory development and testing needs including strong technical support and operational effectiveness at the partner laboratories.

Author and review relevant subsections of regulatory documents and interact with regulatory authorities as requested.

Ensure review bioanalytical documentation that includes study protocols, analysis plans, data packages, validation study reports and sample analysis reports.

Present at scientific conferences and publish in industry journals.

Requirements:

PhD. is required

Experience supervising and developing scientists.

Expertise in flow cytometry data analysis in clinical trials, biomarker and bioanalytical assay development, and cutting-edge methodologies in all phase of clinical trials.

Experience managing external clinical trial vendors and CROs.

Experience providing feedback on clinical trial protocols, analysis plans, data packages, and reports.

Experience with long-term strategic planning to support non-clinical and clinical testing needs.

Experience independently planning and managing projects with a demonstrated history of successful execution.

Ability to manage upward and tailor communications based on audience.

Ability to adapt and be flexible in response to dynamic priorities.

Strong written and oral communication skills.

Strong problem-solving, analytical, and critical thinking skills.

Strong organizational skills.

Strong collaborator.

Work Environment:

The position will be a remote position.

Dynamic, interactive, fast-paced, and entrepreneurial environment.

Domestic travel 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 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 $260,000.00 – $300,000.00.