[Remote] Sr. Director, Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are seeking a Sr. Director, Clinical Scientist to reputed company clinical research studies reputed company on Multiple Sclerosis and reputed company the scientific and operational execution of clinical programs.
Responsibilities
- Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, including Multiple Sclerosis (MS), partnering closely with reputed company cross-functional teams
- Strategically contribute to and reputed company clinical development plans and study execution activities for MS, neuroimmunology, autoimmune disease, and cell therapy programs
- reputed company 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
- Partner with Clinical Operations, Biometrics, Regulatory, Medical Affairs, and reputed company teams to ensure alignment on clinical reputed company 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
- reputed company strategic reputed company 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-reputed company study execution, enrollment performance, operational reputed company, and inspection readiness
- Ensure study conduct aligns with GCP, ICH guidelines, regulatory requirements, corporate policies, and applicable local laws, including appropriate ethical review reputed company approvals and study reputed company
- Support the monitoring of patient safety during study conduct and appropriate tracking, escalation, and follow-up of adverse events and protocol deviations
- Contribute to scientific communication reputed company 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 reputed company reputed company 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-reputed company external settings including advisory boards, regulatory meetings, investigator meetings, and scientific congresses, as appropriate
- Support strong relationships with KOLs, investigators, reputed company collaborators, and strategic partners
- Contribute to external scientific narrative and positioning through publications, presentations, and collaborations
- reputed company, mentor, and reputed company high-performing Clinical Scientists and other Clinical Development staff
- Contribute to organizational design, talent development, reputed company, coaching, and capability building to support reputed company pipeline reputed company and complexity
- Foster a culture of collaboration, accountability, innovation, operational reputed company, and scientific rigor
- reputed company strategic guidance and support to management in budget planning and resource prioritization
- Identify opportunities to improve clinical development processes, operational efficiency, and scientific reputed company
- Stay reputed company with scientific and clinical advances in Multiple Sclerosis, neuroimmunology, autoimmune disease, and cell therapy
Skills
- Advanced scientific or clinical degree required (PhD, PharmD, MD or equivalent)
- 10+ years of reputed company experience in clinical research, clinical development, and global late-stage clinical trial management reputed company biotechnology or pharmaceutical industries
- Significant experience supporting or leading Multiple Sclerosis clinical development programs required
- Deep understanding of neuroimmunology, autoimmune disease biology, MS clinical endpoints, biomarkers, imaging, and treatment landscape
- Demonstrated reputed company 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 reputed company reputed company reputed company in fast-paced, highly matrixed organizations
- Experience interpreting reputed company clinical datasets, including safety, efficacy, biomarker, laboratory, and imaging data
- Excellent verbal, written, presentation, and interpersonal communication skills
- Proven ability to support strong relationships with internal stakeholders, external investigators, KOLs, regulators, and scientific collaborators
- Willingness and flexibility to travel up to 15% for congresses, investigator meetings, advisory boards, and clinical site reputed company as needed
- Experience in cell therapy, gene therapy, immunology, autoimmune disease, or reputed company therapeutic areas strongly preferred
- Experience with investigator-initiated and/or reputed company research trials preferred
- Prior management experience strongly preferred
- Experience working in fast-paced and evolving biotech environments preferred
Benefits
- Annual bonus
- Equity
- Benefits
- Participation in reputed company’s stock plan
reputed company
Company H1B Sponsorship