The Role:

The Clinical Development Leader – Neurology is a key role within Immunovant’s Neurology portfolio. This Clinical Development Leader will lead clinical trials for one or more of Immunovant’s development programs in neurology. Specifically, this role will be directly responsible for Immunovant’s ongoing major study for IMVT-1402 in CIDP.

For this critical position, the Clinical Development Leader will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, site feasibility assessment, protocol development, clinical trial enrollment, sponsor medical monitoring, review, and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.

The successful candidate is driven, curious, patient focused, collaborative, with a bold ambition to contribute to Immunovant’s mission to enable normal lives for people living with autoimmune diseases.

Key Responsibilities: 

• Provide clinical scientific leadership for the clinical study team.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide medical safety oversight of CRO medical monitors.
• Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
• Collaborate closely with partners in Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Lead the design and writing of clinical protocols and associated clinical documents.
• Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
• Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
• Assume primary responsibility for presentations related to clinical trial data and assist in the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
• Contribute to the writing of manuscripts and publications.
• Comply with Immunovant's SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, IMVT BOD meetings, etc.
• Develop and maintain strong, collaborative relationships with the broader Immunovant organization.
• Represent Immunovant externally and build successful relationships with multiple stakeholders including trial site Investigators, KOLs, and others.
• Excellence in verbal and written communication, teamwork, and collaboration is a must.

Requirements:

• A minimum of 8 years’ experience in early to late-stage development in an industry (CRO and/or Pharma) setting.
• Proven ability to: Plan and conduct clinical trials.
• Deliver high-quality results within established timelines.
• Demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
• Prior late phase clinical trial experience in neurology is highly desirable.
• Ability to thrive in a fast-paced environment.
• Proven ability to successfully manage multiple tasks and prioritize accordingly.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Excellent analytical, problem-solving, and strategic planning skills.
• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies would be desirable.

Education

• MD, DO, or non-US equivalent of MD degree.
• Board certification in Neurology is strongly preferred.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (20%)

The Role:

The Senior Director, Regulatory Affairs Strategy is a senior individual contributor and people leader responsible for shaping, influencing, and executing global regulatory strategies across one or more complex development programs. This role serves as a critical bridge between program-level execution and portfolio-level strategic alignment.

The Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. The role requires strong strategic judgment, the ability to navigate ambiguity, and comfort operating in a fast-paced, evolving biotech environment.

Key Responsibilities: 

Regulatory Strategy & Leadership

• Lead the development and execution of innovative global regulatory strategies to expedite development, maximize probability of success, and mitigate regulatory risk across assigned programs.
• Serve as a core regulatory strategist for complex and/or high-priority programs, with accountability for overall regulatory direction and outcomes.
• Anticipate and proactively address regulatory challenges, translating external regulatory trends and guidance into actionable strategies.
• Ensure alignment between program-level strategies and broader portfolio and corporate regulatory objectives.

Health Authority Engagement

• Lead and/or play a prominent role in interactions with FDA and other global Health Authorities, including briefing document development, meeting preparation, negotiation strategy, and follow-up.
• Provide strategic oversight and guidance on responses to regulatory questions, information requests, and post-meeting commitments.

Cross‑Functional Partnership

• Act as the primary regulatory partner on cross-functional development teams, influencing decision-making across R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial functions as appropriate.
• Clearly communicate regulatory risks, opportunities, and recommendations to senior management and key stakeholders.
• Represent Regulatory Affairs Strategy on cross-functional governance forums and committees as needed.

People Leadership & Mentorship

• Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders.
• Support performance management, talent assessment, and succession planning in partnership with Regulatory leadership.
• Foster a culture of accountability, collaboration, and continuous learning within the Regulatory Affairs organization.

Operational Excellence & Oversight

• Oversee and contribute to the planning, preparation, and review of high-quality global regulatory submissions, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing packages.
• Ensure regulatory deliverables are strategically sound, internally aligned, and completed within established timelines.
• Manage or oversee external consultants and vendors to ensure efficient execution and high-quality outcomes.

Requirements:

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) strongly preferred.
• Minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, with demonstrated progression in scope and complexity.
• Significant experience developing and executing global regulatory strategies for biologics across clinical development and, preferably, marketing applications.
• Demonstrated leadership in Health Authority interactions, including FDA and major ex‑US agencies.
• Strong understanding of global regulatory requirements, guidance, and processes (FDA, EMA, ICH, and other key regions).
• Experience leading or contributing to INDs and BLAs; MAA experience preferred.
• Proven ability to think strategically while remaining hands-on as needed.
• Excellent written and verbal communication skills, with the ability to influence senior leaders and cross-functional partners.
• Experience mentoring and developing regulatory talent in a matrixed, fast-paced environment.
• Comfort operating with ambiguity and shifting priorities in a high-growth biotech setting.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-20%)

Geographical areas of focus: Southeast (AR, LA, MS, AL, GA, FL, TN, SC, NC, KY, VA, WV, DC, MD, DE)

The Role:

Reporting to a Senior Medical Director, Medical Affairs, this position is responsible for establishing, developing, and maintaining scientific exchange with key opinion leaders (KOLs), health care professionals (HCPs), clinical trial investigators and payers, aligned with organizational strategic objectives. You will work with clinical research sites and investigators within assigned disease states in our development program(s) to provide clinical support and answer unsolicited requests for information related to our ongoing clinical trial program. You will collaborate closely with cross-functional counterparts, including Site Relations Managers (SRM), Clinical Development, and Commercial colleagues. This role's responsibilities are to ensure the accurate exchange and distribution of clinical and scientific information, collection of key medical insights, and ensure response to medical inquiries in a timely, ethical, and customer-focused manner.

Key Responsibilities: 

• Facilitate scientific exchange between industry and the scientific community to help shape the future of healthcare, providing needed information that addresses important clinical and scientific questions.
• As a core responsibility, establish themselves as a reliable and trusted resource of unbiased, accurate, up-to-date medical and scientific knowledge requested by their KOLs.
• Connect KOLs and represent their voice to internal business partners as appropriate and identify possible research or external collaborations.
• Demonstrate strategic analysis, planning, and prioritization to maximize efficiency and adhere to all Immunovant and field medical affairs policies and procedures.
• Enhance professional expertise through attendance of select scientific meetings and professional conferences for the purpose of scientific exchange with key opinion leaders, gathering competitive intelligence, generating clinical trial awareness, and maintaining clinical and scientific expertise
• Expertise in geography management to coordinate KOL engagements and development, and Immunovant clinical trial support through a KOL engagement plan
• Interact with investigator sites and other parties to support clinical trial execution. The MSL provides regional and country-specific insights and site feedback to support site identification, patient recruitment, and retention initiatives. In close collaboration with the study team,  and the SRMs, the MSL acts as a medical resource for sites to facilitate resolution of issues related to requests for clinical trial and scientific information, attends and may present at Investigator meetings, and may monitor workshops/training.
• Demonstrate strategic analysis, planning, and prioritization to maximize efficiency and adhere to all Immunovant and field medical affairs policies and procedures.
• Actively contribute and engage with internal Medical Affairs colleagues in team meetings and presentations, share competitive intelligence updates, assist with the training of new MSLs, and share feedback on new educational materials/training.
• Compliantly collaborate with internal stakeholders, including but not limited to MSL field partners, site relationship managers, clinical operations, and commercial teams.

Requirements:

• An advanced degree in health sciences (PharmD, DNP, MD, or PhD) is required, as well as at least 3 years of relevant industry experience as an MSL.
• Master’s or bachelor’s level degree in science-related fields (e.g., BS, BSN, RPh, PA, NP) considered if 5 or more years of industry experience as an MSL in a relevant therapeutic area is present.
• Global Medical Affairs experience highly preferred.
• Learning agility to comprehend and effectively communicate large amounts of complex scientific content in a clear and concise fashion.
• Self-directed and able to work alone in the field, effectively managing multiple priorities and projects.
• Advanced presentation and computer skills with expertise in literature identification.
• Effective strategic and critical thinking is needed to analyze, assess, and evaluate information and interpret its impact or relevance to future disease states.
• Effective verbal and written communication skills.
• Strong teamwork and interpersonal skills, including high emotional intelligence and the ability to engage in professional relationship-building and networking.
• Extensive experience in professional networking with mutual experience in a field-based working environment is highly valued.
• Familiarity with health systems, academic communities, medical research, and medical education process.
• A field-based position covering regional geography requires the ability to travel (estimated at 60% +/- and work up to 4 to 6 weekends a year).
• Flexibility to have changing therapeutic area focus as needed as our company and research focus continue developing.

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment.
• The Immunovant headquarters is in Durham, NC, and the regional office is in New York City. The position is remote with field-based regional geography coverage.
• Domestic travel required (estimated at 60% +/- and up to 4 to 6 weekends a year).

The Role:

The Head of Commercial Operations leads all operational functions that enable effective commercialization across the organization. This role oversees sales operations, marketing operations, medical operations, and launch planning to ensure seamless execution, data‑driven decision‑making, and cross‑functional alignment. This role will initially oversee market research and analytics. The leader will partner closely with Commercial, Medical Affairs, Market Access, Finance, and Supply Chain to support strategic planning and operational excellence

Key Responsibilities:

Commercial Strategy & Leadership

• Drive the operational strategy supporting U.S. commercial business objectives, ensuring alignment across sales, marketing, medical, and analytics teams.
• Serve as a strategic advisor to senior leadership on commercial performance, resource allocation, and market dynamics.
• Build and lead a high‑performing Commercial Operations organization with clear accountability and development pathways.

Sales Operations

• Oversee forecasting, demand planning, and sales performance reporting to support revenue goals.
• Manage CRM systems, field force tools, incentive compensation design, and territory alignment.
• Ensure timely and accurate reporting of sales, orders, bids, and pricing decisions.
• Partner with Sales Leadership to optimize field execution and operational efficiency.

Marketing Operations

• Lead the development and execution of marketing operations infrastructure, including campaign management, digital platforms, and promotional material workflows.
• Ensure compliant review and approval processes in partnership with Regulatory, Legal, and Medical.
• Oversee budget tracking, vendor management, and performance analytics for marketing initiatives.

Medical Operations

• Support Medical Affairs in operational planning, including advisory boards, scientific congresses, and medical education programs.
• Oversee systems and processes for compliant HCP engagement, medical information workflows, and scientific content operations.
• Partner with Medical leadership to ensure alignment between commercial and medical strategic priorities.

Launch Planning & Operations

• Serve as the operational lead for product launches, ensuring cross‑functional readiness across Commercial, Medical, Market Access, Supply Chain, and Compliance.
• Develop and manage launch plans, KPIs, timelines, and risk mitigation strategies.
• Coordinate with CMC, clinical, and supply teams to support launch readiness activities.

Cross‑Functional Collaboration

• Partner with Finance on revenue planning, pricing strategy, and gross‑to‑net modeling.
• Collaborate with Supply Chain to ensure demand alignment and inventory planning.
• Work with IT to maintain and enhance commercial systems, data infrastructure, and analytics platforms.

Governance, Compliance & Process Excellence

• Ensure all commercial operations adhere to industry regulations, including FDA, OIG, and company compliance standards.
• Establish SOPs, governance frameworks, and operational best practices across commercial functions.
• Drive continuous improvement initiatives to enhance efficiency, scalability, and data quality

Interim Market Research & Analytics

• Lead the generation of actionable insights through primary and secondary research, competitive intelligence, and advanced analytics.
• Build dashboards and reporting frameworks to support real‑time decision‑making across the commercial organization.
• Translate data into strategic recommendations for brand planning, forecasting, and lifecycle management.

Requirements:

• BA/BS required; MBA and/or other relevant graduate degree strongly preferred
• Minimum 15+ years of experience in pharmaceutical/biotech industry or related healthcare industry, small/biotech company experience preferred
• Proven leadership experience managing cross‑functional teams in a commercial or launch‑focused environment.
• Strong understanding of U.S. pharmaceutical commercialization, including sales models, medical affairs, analytics, and launch processes.
• Demonstrated ability to translate data into strategic insights and operational plans.
• Excellent leadership and interpersonal skills; should be an effective team player who can engender credibility and confidence
• Previous experience managing a team
• Excellent oral, written and presentation skills
• Experience supporting launch products
• Strong cross-functional and interpersonal skills
• Ability to effectively manage multiple competing priorities

Work Environment:

• Hybrid, Two-three days in Immunovant’s NYC
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (20% - 25%)

The Role:

The Director of Product Marketing is critical to the success of the commercial launch of IMVT-1402 and the successful transformation of the company from a clinical-stage company to a commercial-stage company.  Reporting to the Senior Vice President of Commercial, this position helps build strategic and tactical launch plans for IMVT-1402 in Graves’ Disease.

Key Responsibilities:

Product Marketing

• Develop an insight driven marketing strategy and positioning for the brand through the application of a strategic framework that relies on key leverage points and strategic choices to determine targeting scenarios.
  • Lead cross functional team, build and shape all launch plans to ensure organizational readiness and success
• Partner closely with Business Analytics to develop robust market research plan to ensure market insights and competitive intelligence are included in all plans and forecast assumptions.
  • Partner with Analytics to shape market research, inform key performance metrics, and measure the effectiveness of marketing initiatives.
• Develop and implement tactics aligned to the brand strategic choices and key leverage points. Ensure alignment with product positioning, and messaging across targeted HCP and consumer tactics while maintaining a high standard of quality and compliance for Immunovant.
• Lead the implementation of a disease educational campaign shaping the market for a new entrant and catalyzing a change in Graves’ Disease understanding and treatment approach
• Lead implementation of brand/launch strategies through development of effective promotional materials for key customer segments (e.g., HCPs, patients, KOLs, allied health professionals, market access stakeholders) and across multiple channels.
• Partner with digital marketing to establish all multi-channel specific strategies and tactics including those necessary to support the Customer Engagement team e.g.: face to face, digital, CRM etc.
• Maintain expertise in disease state, competitive landscape, and market dynamics, informing potential pivots in strategic and executional approach as needed
• Responsible for the management and evaluation of key agencies and vendors

Requirements:

• BA/BS required; MBA and/or other relevant graduate degree preferred
• 8+ years of marketing experience in a biotechnology or pharmaceutical organization. Launch experience required
• Track record of enterprise influence - able to lead through ambiguity, align diverse stakeholders, and drive decisions across functions outside of direct reporting lines.
• Strong communication skills; able to synthesize complex inputs into clear recommendations for senior leadership.
• Demonstrated analytical and problem-solving skills, leading to the development of innovative marketing initiatives.

Work Environment:

• Hybrid; Immunovant’s NYC office 3 days/week
• Dynamic, interactive, fast-paced, and entrepreneurial environment 
• Domestic or international travel are required (20% - 25%)

The Role:

The Senior Director, Clinical Pharmacology is responsible for developing clinical pharmacology plans and overseeing the execution of these plans across therapeutic areas and in all phases of clinical development. This leadership role will have direct reports and is an integral member of the project team and serves as the clinical pharmacology and pharmacometrics lead for individual asset(s). This person designs and interprets clinical pharmacology studies and writes relevant sections of regulatory documents, protocols, and study reports. They use exploratory data analyses techniques, modeling, and simulations to accelerate development and support dosing, study designs, and development plans. They perform pharmacometrics analyses or provide scientific oversight of pharmacometrics analyses performed by external resources.

Key Responsibilities:

• Serve as the head of clinical pharmacology and leader of the function for all indications
• Develop clinical pharmacology strategy for all Immunovant compounds and design, interpret, and conduct clinical pharmacology studies
• Provide clinical pharmacology support for Ph 1, 2, and 3 studies
• Support clinical pharmacology aspects of regulatory submissions including writing and review of relevant sections
• Provide data analyses, modeling and simulation to support asset development; perform pharmacometrics analyses or provide scientific oversight of pharmacometrics analyses performed by external resources.
• Collaborate closely with Regulatory to provide CP support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of relevant BLA sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings).
• Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed.

Requirements:

• PhD, PharmD, or MD with training in CP, PK/PD, Pharmacology, and Pharmaceutical Sciences.
• 8-10 years of experience in the application of CP within the context of drug development in the healthcare industry.
• Experience in leadership of CP regulatory submission and approvals of at least one original or major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional)
• Proven track record of clinical pharmacology and pharmacokinetic / pharmacometrics support for regulatory submissions (e.g., EoP2, IND, NDA, MAA, PIP)
• Experience and expertise with pharmacokinetics / pharmacometrics methods and software (e.g, NONMEM, WinNonlin)
• Deep understanding of drug development and the integration across the various functions including nonclinical, clinical, CMC, regulatory, finance and legal.
• Knowledge of regulatory expectations for clinical pharmacology
• Excellent written and oral communication skills with meticulous attention to detail.
• Thrives in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
• Natural collaborator who enjoys working on a cross-functional team.

Work Environment:

• Immunovant’s headquarters is located in New York City.  The position is flexible for remote work.
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel may be required (<10%).

The Role:

The Vice President of Drug Safety and Pharmacovigilance (VP, DSPV) will serve as the global leader for Immunovant product safety and report to the Chief Operating Officer. The individual will provide strategic vision and operational oversight across all aspects of drug safety while ensuring regulatory compliance globally.

The VP, DSPV will lead all pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as with external regulatory authorities. The VP, DSPV oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management. The VP, DSPV is also responsible for managing the organizational planning, budget and operations of the department.

Key Responsibilities: 

• Authority and accountability to develop, organize, manage and maintain a highly compliant PV system for Immunovant
• Medical expert accountable for overall DSPV strategy and all deliverables of the DSPV function, including responsibilities for pharmacovigilance-related documents (e.g., DSUR) as well as safety sections of key documents (e.g., IBs, RSI, ICFs, study protocols, CSRs) and other applicable activities (IND/CTA, requests for information, regulatory responses)
• Strategic decision maker accountable for providing medical and scientific expertise for product safety and risk assessments at all stages of product lifecycle
• Responsible for oversight of the DSPV department, including building and managing a team of DSPV professionals (operations and safety science) to execute the development strategy and support registrational/post-marketing activities in a compliant and collaborative environment, in accordance with long-term strategic goals
• Serves as lead safety representative in regulatory interactions and interactions with internal governance frameworks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
• Collaborate with appropriate (clinical, medical, quality, and regulatory counterparts and others across the business), to provide input and oversight for all safety and PV issues
• Responsible for leading relevant Safety committees and teams
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Ensure ongoing audit and inspection readiness of the DSPV function.
• Responsible for department planning and forecasting efforts in relation to resources and overall management of PV budget.

Requirements:

• MD or equivalent degree; additional training/experience with rare diseases is preferred
• 12 + years of relevant industry experience in biotech and/or pharmaceutical settings with significant time spent in senior leadership roles, including 5+ years of direct experience in Drug Safety and Pharmacovigilance (development and commercial stage)
• Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments
• Extensive knowledge of regulatory and compliance requirements governing drug safety and pharmacovigilance, as well as an overall understanding and knowledge of BLA global filing requirements
• Proven prior experience with guiding a Drug Safety and Pharmacovigilance team through BLA and commercialization
• Experience in building out DSPV marketed product infrastructure
• Demonstrated thorough knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management )
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication

 Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)