Sr. Director, Clinical Scientist

Responsibilities

Clinical Development Strategy & Leadership

• Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, including Multiple Sclerosis (MS), partnering closely with internal and external cross-functional teams.

• Strategically contribute to and lead clinical development plans and study execution activities for MS, neuroimmunology, autoimmune disease, and cell therapy programs.

• Lead the design, execution, interpretation, and reporting of clinical trials across assigned programs, including study endpoints, biomarkers, imaging strategies, sample size considerations, patient enrollment approaches, timelines, and governance interactions.

• Represent Clinical Development for assigned programs with cross-functional leadership teams, key opinion leaders (KOLs), investigators, strategic partners, and external stakeholders.

• Serve as a scientific subject matter expert in Multiple Sclerosis, neuroimmunology, autoimmune disease biology, and cell therapy.

• Maintain deep understanding of preclinical and clinical data relevant to the therapeutic platform, competitive landscape, and evolving MS treatment landscape.

• Contribute to clinical development strategies incorporating biomarkers, MRI/imaging, translational endpoints, relapse assessment, and disability progression measures relevant to MS disease activity and progression.

Clinical Trial Execution & Oversight

• Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and Commercial teams to ensure alignment on clinical strategy and execution.

• Write and review scientific content of key clinical and regulatory documents including protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), safety updates, annual reports, BLA/CTA submission materials, and responses to Health Authorities.

• Provide strategic oversight of informed consent language and patient risk communication.

• Review and interpret safety, efficacy, MRI/imaging, biomarker, laboratory, relapse, and disability progression data throughout study conduct.

• Participate in investigator identification, selection, training, and site engagement activities, with emphasis on leading MS clinical trial sites and investigators.

• Collaborate with CROs and vendors to ensure high-quality study execution, enrollment performance, operational excellence, and inspection readiness.

• Ensure study conduct aligns with GCP, ICH guidelines, regulatory requirements, corporate policies, and applicable local laws, including appropriate ethical review board approvals and study oversight.

• Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations.

Scientific Communication & External Engagement

• Contribute to scientific communication strategy and dissemination of clinical data across the MS, neuroimmunology, autoimmune disease, and cell therapy communities.

• Support development of scientific materials including slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reports.

• Prepare and review scientific responses to healthcare professional inquiries, scientific exchange requests, and external communications.

• Participate in Publication Steering Committees (PSC), advisory boards, scientific committees, and major congresses relevant to neurology, immunology, autoimmune disease, and cell therapy.

• Represent Clinical Development in high-impact external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses, as appropriate.

• Support strong relationships with KOLs, investigators, academic collaborators, and strategic partners.

• Contribute to external scientific narrative and positioning through publications, presentations, and collaborations.

Leadership & Organizational Development

• Lead, mentor, and develop high-performing Clinical Scientists and other Clinical Development staff.

• Contribute to organizational design, talent development, onboarding, coaching, and capability building to support future pipeline growth and complexity.

• Foster a culture of collaboration, accountability, innovation, operational excellence, and scientific rigor.

• Provide strategic guidance and support to management in budget planning and resource prioritization.

• Identify opportunities to improve clinical development processes, operational efficiency, and scientific quality.

• Stay current with scientific and clinical advances in Multiple Sclerosis, neuroimmunology, autoimmune disease, and cell therapy.

Qualifications

• Advanced scientific or clinical degree required (PhD, PharmD, MDor equivalent).

• 10+ years of progressive experience in clinical research, clinical development, and global late-stage clinical trial management within biotechnology or pharmaceutical industries.

• Significant experience supporting or leading Multiple Sclerosis clinical development programs required.

• Experience in cell therapy, gene therapy, immunology, autoimmune disease, or related therapeutic areas strongly preferred.

• Deep understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and treatment landscape.

• Demonstrated success developing and executing clinical strategies across multiple programs, including late-stage global clinical trials.

• Strong knowledge of GCP, ICH guidelines, global regulatory frameworks, regulatory requirements, and clinical trial methodology.

• Strong operational acumen with the ability to independently lead complex projects in fast-paced, highly matrixed organizations.

• Experience interpreting complex clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data.

• Experience with investigator-initiated and/or collaborative research trials preferred.

• Prior management experience strongly preferred.

• Excellent verbal, written, presentation, and interpersonal communication skills.

• Proven ability to support strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaborators.

• Experience working in fast-paced and evolving biotech environments preferred.

• Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site visits as needed.