Director, Clinical Scientist - Immunology

Socket.dev; Kendall Square (MA); On-site; USD 204,000 - 306,000; Full time

Job summary

Socket.dev is seeking a Director, Clinical Scientist, Neuroimmunology to drive study-level clinical science across the neuroimmunology portfolio, focusing on multiple sclerosis and related indications. You will own end-to-end medical oversight, reviews, and regulatory-facing deliverables, mentoring junior scientists and collaborating with cross-functional teams.

In this role, you will translate development plans into inspection-ready studies, manage documents like protocols and CSR

Qualifications

• Advanced scientific or clinical degree in life-sciences.
• At least 6 years' clinical-development experience; neurology/MS preferred.
• Experience designing and delivering clinical trials and CSR authorship.
• Deep knowledge of ICH-GCP and global regulatory expectations across Phases 1–3.
• Proficiency with clinical databases, listings review, and coding.

Responsibilities

• Lead study-level clinical-science engine and document ownership.
• Perform routine medical and data review, safety-surveillance, and logs—tracking actions and decisions.
• Draft/regulate clinical sections of regulatory documents and responses, supporting regulatory interactions.
• Mentor junior clinical scientists and coordinate with Study Physician and GCPL.
• Ensure data readiness, SAP/TLF alignment, and inspection-ready outputs.

Skills

Clinical development

ICH-GCP knowledge

Regulatory interactions

Data review & interpretation

Medical monitoring

Cross-functional collaboration

Mentoring

Education

Advanced scientific degree (PhD/PharmD/MD)

Tools

Medidata Rave

J-Review

SAS

R

Job description

Are you an experienced clinical scientist who wants to help bring transformative cell and immunotherapies to patients with serious immune-mediated neurological disease? Do you combine deep hands-on study execution, from medical and data review to endpoint integrity and document authorship, with the judgment to run the clinical-science engine of a trial with minimal escalation? Do you thrive where strategy meets day-to-day ownership, and enjoy mentoring more junior scientists? If so, we invite you to join us. We are seeking a Director, Clinical Scientist, Neuroimmunology to drive study-level clinical science across our neuroimmunology portfolio, starting in multiple sclerosis and extending to additional immune-mediated neurologic indications.

The Director, Clinical Scientist leads the day-to-day clinical-science engine of one or more studies, working synergistically with the Study Physician as the expert on the medical-scientific and operational-science aspects of our compounds and their development. You will report to the Global Clinical Head, Neuroimmunology, or their designee, and partnering closely with the Study Physician and the Global Clinical Program Lead (GCPL), you will translate the program's clinical development plan into inspection-ready, decision-enabling studies. You will own document cycles, continuous medical and data review, endpoint integrity, and the site and CRO clinical-science interface, so that routine clinical-science work is handled at the study level. You will operate in compliance with GCP, AZ quality systems, and relevant regulatory guidelines, and will help develop and mentor junior clinical scientists. The GCPL leads the program's clinical development strategy and holds program-level accountability. Medical judgement, benefit-risk, and final medical sign-off sit with the Study Physician; program strategy and cross-study trade-offs are set with the GCPL.

Typical Accountabilities

Document ownership and operational translation

• Act as lead author and reviewer for study-level documents in alignment with the clinical development plan, including protocols and amendments, IB updates, ICFs, clinical and scientific training materials, medical monitoring plans, and charters such as MRI central read and relapse adjudication. Manage version control and cross-document consistency.
• Translate protocol intent into operational deliverables such as CRFs and eCRF completion guidelines, lab and pharmacy manuals, and rater guidance. Own the protocol clarification log and ensure site workflows support endpoint quality and data timeliness.
• Ensure clinical study protocols and associated documents align with the clinical development plan and connect trial data to the Target Product Profile.

Ongoing medical and data review and safety-surveillance partnership

• Perform routine, independent review of patient profiles, listings, coded terms, and narratives. Run trend checks across safety, efficacy, and protocol compliance, and maintain issue, action, and decision logs, driving timely closure.
• Contribute to the interpretation of emerging clinical data and identification of clinically meaningful findings, trends, and questions for further evaluation by the study team.
• Own the day-to-day execution of study-level medical oversight as defined in the Study-Level Medical Oversight Plan (SLMOP), ensuring participant-level and aggregate reviews occur at
• the specified frequencies, with outcomes documented and filed to the TMF per SOP and SLMOP timelines.

• Partner with Pharmacovigilance on AE and SAE triage, reconciliation, and timely narrative drafting. Conduct AESI reviews and trending (these include CRS, neurotoxicity/ICANS, infections, IEC-HS, IEC-associated colitis, and new malignancies), prepare SRC, IDMC, and DMC safety packets, and flag emerging signals promptly with proposed next steps, bringing medical-judgement items to the Study Physician.
• Perform real-time participant-level eligibility reviews during screening, and drive query generation, coding reconciliation, and edit-check refinement with Data Management and Biostatistics.

Data readiness, SAP/TLF alignment, and decision enablement

• Lead the query and data-cleaning strategy to hit LPLV, interim, and database-lock milestones with inspection-ready documentation.
• Ensure traceability from protocol to SAP and TLF shells, review analysis populations, estimands, and endpoints, and validate mock outputs for decision quality.
• Build clear, integrated readouts across safety, efficacy, PK/PD, biomarkers, and operations, with options and recommendations for governance, and maintain decision and assumption logs.

External interface, regulatory support, and disclosures

• Serve as first-line clinical and scientific responder for routine questions from sites and CROs, providing consistent, timely clarifications, support site initiation visits and investigator meetings. Lead root-cause analysis and CAPAs with Clinical Operations and vendors.
• Draft and review clinical sections of regulatory documents and responses, including HA interactions, briefing books, IND and annual reports, PIPs, and safety updates, ensuring SLMOP-driven surveillance outputs are reflected accurately and aligned with GCP, ICH, FDA, and EMA expectations.
• Lead development, review, and quality of abstracts, posters, manuscripts, and scientific presentations, ensuring data coherence across disclosures.

Mentorship and continuous learning

• Provide study-specific onboarding and support for Study Physicians and coach junior Clinical Scientists on study background, systems, oversight processes, and effective communication and expectations.
• Track key developments in the MS, neuroimmunology, and cell-therapy literature and competitive landscape, and propose pragmatic protocol or analysis optimizations that improve probability of success without destabilizing operations.

Essential Qualifications and Skills

• Advanced scientific or clinical degree (PhD, PharmD, MD, or equivalent) in a life-sciences or related field.
• At least 6 years' clinical-development experience, with strong hands-on study execution and medical and data review. Neurology or multiple sclerosis experience preferred.
• Proven experience designing and delivering clinical trials, including protocol and ICF development, medical monitoring and safety data review, IB and DSUR contributions, clinical data review and interpretation, and CSR authorship.
• Deep working knowledge of ICH-GCP and global regulatory expectations across Phase 1 and 2, with Phase 3 a plus, and experience contributing clinical-science content to regulatory interactions and submissions such as IND/CTA.
• Proficiency with clinical databases, listings review, and coding, and effective collaboration with Biostatistics, Data Management, and Pharmacovigilance.
• Command of clinical-trial methodology and statistical concepts sufficient to support data-driven decision-making.
• Demonstrated cross-functional collaboration, the ability to influence internal and external stakeholders, learning agility, and solution-focused problem-solving.
• Attention to detail, an ownership mindset, and a track record of delivering results.

Desirable Skills

• Direct clinical-development experience in CAR-T or other engineered cell therapies, and/or T-cell engagers, across autoimmune or inflammatory indications, including operational constraints such as chain-of-identity/control and vein-to-vein logistics, and CMC-clinical interfaces.
• Understanding of end-to-end cell-therapy development across research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, and commercial.
• Experience mentoring or providing work direction to junior scientists.
• External credibility with investigators, academic partners, consortia, and CROs.
• Data-analysis and programming familiarity (for example R, SAS, Python) and clinical-review tools (for example Medidata Rave, J-Review).
• Ability to travel nationally and internationally.

The annual base pay (or hourly rate of compensation) for this position ranges from USD $203,709.60 - $305,564.40 Annual Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

18-Sep-2026

Closing Date

01-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.