Director, Clinical Scientist

Trace Neuroscience, Inc.; Boston (MA); On-site; USD 250,000 - 275,000; Full time

Job summary

Trace Neuroscience, Inc. in Boston, MA, seeks a Clinical Scientist to shape clinical strategy for ALS and other neurodegenerative programs, guiding trials and regulatory submissions. The role requires leadership across Clinical Operations, Regulatory, Biostatistics, Translational Medicine, and Research.

The ideal candidate holds a Ph.D. or M.D. with 5+ years in biotech/pharma clinical development, including first-in-human and Phase 2 studies, and demonstrates rigorous scientific and clinical

Qualifications

• Minimum of 5 years of clinical development experience in a biotechnology or pharmaceutical organization.
• Experience supporting first-in-human and Phase 2 and confirmatory trials.
• Strong scientific and clinical data interpretation skills.
• Excellent communication, presentation, and relationship-building abilities.

Responsibilities

• Contribute to clinical development strategy for ALS and other neurodegenerative programs.
• Provide medical oversight for trials from protocol design through regulatory submissions.
• Collaborate with cross-functional teams to integrate biomarkers and disease biology into development plans.
• Prepare regulatory briefing materials and support interactions with regulatory authorities.

Skills

Clinical development

Regulatory strategy

Cross-functional leadership

Biotech/pharma experience

Scientific communication

Education

Ph.D. or M.D.

Job description

At Trace Neuroscience (Trace), our vision is to bring the promise of genetic medicine to all people living with ALS. ALS, or amyotrophic lateral sclerosis, is a rapidly progressive, fatal, neuromuscular disease that affects motor neurons in the brain and spinal cord. It is a devastating disease for people living with ALS and their families. Trace is a biotechnology company advancing innovative genetic therapies designed to restore UNC13A, an essential synaptic protein, to improve outcomes for people living with ALS. The same mechanism is also relevant for people living with frontotemporal dementia and probably other neurodegenerative diseases. Founded through collaboration among leading scientists, industry experts, and investors, Trace is developing a new generation of treatments grounded in human genetics and a deep understanding of disease biology.

At Trace, our values of urgency, unity, and drive fuel everything we do. We embrace a sense of immediacy, understanding that every moment matters for those living with ALS, as well as their caregivers and families. As a lean team, we foster a culture that combines individual accountability with a shared responsibility for our ambitious mission. We believe effective collaboration is essential, so we encourage open communication, mutual support, and collective problem-solving. Building on our founders' fundamental discoveries, our growing team is driven to turn cutting-edge science into effective medicine.

We invite you to consider an opportunity with Trace Neuroscience to help achieve our goal of delivering meaningful treatments to people living with ALS.

Position Summary

Reporting to the Chief Medical Officer, the Clinical Scientist will serve as a key member of the Clinical Development organization and provide medical and scientific expertise across Trace's clinical development programs. This individual will help shape the clinical strategy for our lead and future pipeline programs, supporting the advancement of innovative therapies for ALS and other neurodegenerative diseases.

The Clinical Scientist will work cross-functionally with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Research, Quality, and external partners to support the design, implementation, and oversight of clinical trials. The role will engage with key opinion leaders and patient advocacy organizations and help translate emerging scientific insights into development decisions.

The ideal candidate is a collaborative, hands-on physician and/or scientist leader with experience in biotechnology drug development. This individual will thrive in a fast-paced, entrepreneurial environment and bring scientific rigor, sound clinical judgment, operational excellence, and a passion for improving the lives of people living with devastating diseases.

Clinical Development Strategy

• Contribute to the development and execution of clinical development strategies for ALS and other neurodegenerative disease programs.
• Provide scientific leadership for clinical trials from protocol design through regulatory submissions, timely trial completion, and reporting.
• Engage with clinical sites and key experts globally
• Participate in clinical development planning, including indication selection, patient population strategy, endpoint development, and benefit-risk assessment.
• Collaborate with Translational Medicine and Research teams to integrate biomarkers and disease biology into development plans.
• Support preparation of clinical development documents, including protocols, investigator brochures, clinical trial reports, and regulatory briefing materials.

Clinical Trial Oversight

• Provide scientific and medical oversight throughout trial conduct.
• Review eligibility determinations and protocol deviations.
• Partner closely with Clinical Operations for efficient trial execution.
• Collaborate with Biostatistics, Clinical Pharmacology, and Translational Sciences teams to evaluate Pharmacokinetics and Pharmacodynamics (PK and PD), biomarkers and other exploratory efficacy signals.

Regulatory & Health Authority Interactions, preparing for Market Access

• Support interactions with the FDA, EMA, and other global regulatory authorities.
• Contribute to regulatory submissions, briefing books, meeting preparations, and responses to agency questions.
• Provide scientific and medical input into Investigational New Drug (IND) applications, clinical trial amendments, annual reports, and future marketing applications.
• Partner with Biostatistics and Translational Sciences to plan timely topline and subsequent comprehensive analyses.
• Support the design of early and confirmatory trials that satisfy both regulatory and market access needs in a competitive trial environment.
• Develop and maintain relationships with key opinion leaders, investigators, academic collaborators, and patient advocacy organizations.
• Represent Trace at scientific conferences, investigator meetings, advisory boards, and external scientific forums.
• Contribute to scientific publications, abstracts, presentations, and dissemination of clinical data.
• Monitor external scientific and competitive developments relevant to ALS and other relevant neurodegenerative diseases

Cross-Functional Collaboration

• Partner with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Clinical Pharmacology, and Regulatory Affairs, Quality, and Research teams to support successful trial execution and data interpretation.
• Work with Biostatistics to support data review, interpretation, and clinical trial analyses.
• Provide clinical and scientific expertise to support business development evaluations, diligence activities, and strategic partnerships.

Compliance & Risk Management

• Ensure clinical trials are conducted in accordance with the protocol and company policies.
• Support inspection readiness and participate in audits and regulatory inspections as needed.
• Promote a culture of scientific and clinical rigor and integrity, and ethical conduct.
• Identify and proactively manage clinical and scientific risks.

Qualifications

Required

• Ph.D. or M.D., with clinical development experience in CNS and/or rare disease indications
• Minimum of 5 years of clinical development experience in a biotechnology or pharmaceutical organization. At least 2 years in biotechnology strongly preferred.
• Experience supporting first-in-human and Phase 2 and confirmatory clinical trials.
• Strong scientific and clinical data interpretation skills.
• Excellent communication, presentation, and relationship-building abilities.
• Ability to operate effectively and independently in a fast-paced, highly collaborative environment.

Preferred

• Direct experience in ALS, neurodegenerative or neuromuscular diseases, and/or rare disease drug development.
• Experience supporting regulatory interactions.
• Experience with genetic medicine modalities, such as oligonucleotides, gene therapies, gene-editing therapies, or other genomic medicines.
• Demonstrated success contributing to clinical trial execution on time and on budget
• Track record of working with key opinion leaders and external scientific stakeholders.

Core Competencies

• Patient-centric mindset
• Strong scientific and clinical judgment
• Scientific rigor and curiosity
• Strategic thinking and execution
• Cross-functional leadership and collaboration
• Sense of urgency and accountability
• Adaptability and resilience
• Commitment to Trace's mission, values, and culture

Travel Requirements

Ability to travel globally approximately 20-30% for investigator meetings, clinical trial oversight, advisory boards, regulatory meetings, and scientific congresses.

Pay Range

In compliance with applicable pay transparency laws, the expected base salary range for this position is $250,000 to $275,000 annually. This range represents the Company's good-faith estimate of the salary range for this role at the date of hire and is subject to change.

Equal Opportunity Employer

Trace Neuroscience is committed to creating a diverse environment and is proud to be an equal opportunity employer. We are dedicated to building an inclusive workplace where all employees can contribute, grow, and succeed while advancing our mission to deliver transformative therapies for people living with ALS.