Senior Medical Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the senior physician for CAR T-cell therapy clinical trials focusing on autoimmune diseases.

• Direct clinical development strategies and oversee study execution for neuroimmunology, autoimmune diseases, and cell therapy initiatives.

• Spearhead the design, implementation, analysis, and reporting of clinical trials, which includes determining endpoints, biomarkers, imaging strategies, sample sizes, enrollment processes, timelines, and governance structures.

• Serve as the representative for Clinical Development in interactions with leadership teams, key opinion leaders (KOLs), investigators, strategic partners, and external stakeholders.

• Supervise medical monitoring and interact with site investigators and external medical monitors.

• Provide medical and scientific insights for development plans, protocols, investigator brochures, and regulatory submissions.

• Draft and review protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), safety updates, annual reports, Biologics License Application (BLA)/Clinical Trial Application (CTA) materials, and responses for health authorities.

• Analyze and interpret data related to safety, efficacy, MRI/imaging, biomarkers, laboratory results, relapse occurrences, and disability progression.

• Engage in the identification, selection, training, and onboarding of investigators and site engagement.

• Collaborate with Contract Research Organizations (CROs) and vendors to ensure effective study execution, enrollment performance, operational excellence, and readiness for inspections.

• Guarantee adherence to Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, regulatory standards, corporate policies, local laws, ethical approvals, and study oversight.

• Assist in monitoring patient safety, tracking adverse events, managing escalations, and following up on protocol deviations.

• Contribute to the scientific communication strategy and the dissemination of clinical data.

• Aid in the preparation of slide decks, abstracts, posters, manuscripts, publications, congress presentations, and regulatory reports.

• Prepare and review responses to inquiries from healthcare professionals and scientific exchange requests.

• Participate in publication committees, advisory boards, scientific committees, and major congresses.

• Represent Clinical Development at advisory boards, regulatory meetings, investigator meetings, and scientific congresses.

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

• Contribute to organizational design, talent development, onboarding processes, coaching, and capability enhancement.

• Identify opportunities to enhance clinical development processes, operational efficiency, and scientific integrity.

• Keep abreast of advancements in neuroimmunology, autoimmune diseases, and cell therapy.

⛳️ Requirements

• MD, DO, or equivalent qualification from outside the United States is required.

• Minimum of 5 years of clinical research experience is necessary.

• At least 4 years of industry experience in clinical development, specifically in clinical trial design and execution, is essential.

• Experience in late-stage clinical development is highly preferred.

• Specialized training in neurology, rheumatology, nephrology, and/or industry experience in the clinical development of cell therapies and/or treatments for autoimmune diseases is strongly preferred.

• Capability to interpret, discuss, and present efficacy and safety data effectively.

• Extensive knowledge of GCP/ICH, clinical trial design, clinical development workflows, and regulatory requirements is essential.

• Ability to independently manage complex projects within a fast-paced, highly matrixed organization is crucial.

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

• Preference for experience in investigator-initiated and/or collaborative research trials.

• Exceptional verbal, written, presentation, and interpersonal communication skills are required.

• Ability to cultivate relationships with internal stakeholders, investigators, KOLs, regulators, and scientific collaborators is essential.

• Experience in dynamic and rapidly evolving biotech environments is preferred.

🏝️ Benefits

• Eligibility for bonuses.

• Comprehensive health and welfare benefits.

• Participation in the company's stock plan.

• Up to 15% travel flexibility for congresses, investigator meetings, advisory boards, and clinical site visits.