Alkeus Pharmaceuticals, Inc. · 3 hours ago
Senior Clinical Scientist
Cambridge, MA
Full-time
Onsite
Senior Level
$160K/yr - $240K/yr
6+ years expAlkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye. The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late-stage clinical development programs in rare disease ophthalmology, ensuring the scientific integrity and successful execution of pivotal clinical trials.
BiotechnologyMedicalMedical DevicePharmaceutical
Responsibilities
Provide scientific leadership for Phase 3 clinical trials, including contributions to overall clinical development strategy, study design, endpoint selection, and patient population definition, with a focus on rare disease and ophthalmology indications
Lead or co-lead the development of pivotal study protocols, informed consent forms, and key scientific sections of regulatory documents, ensuring alignment with global regulatory expectations (FDA, EMA, and other health authorities)
Serve as the scientific point of contact for assigned programs, providing ongoing oversight throughout trial execution, including review of emerging data, identification of scientific risks, and interpretation of results
Partner closely with clinical operations to ensure Phase 3 trials are scientifically sound, operationally feasible, and executed in accordance with protocol, timelines, and quality standards
Collaborate with biostatistics and data management to support statistical analysis plans, data review activities, interim analyses (as applicable), and final interpretation of clinical outcomes
Contribute to and support regulatory interactions, including preparation of briefing documents, responses to information requests, and participation in meetings with health authorities as a scientific representative of the program
Lead or significantly contribute to the preparation of clinical study reports, integrated summaries, investigator brochures, external presentations, scientific content for regulatory submissions, publications, author responses to questions from health authorities and other stakeholders
Support safety monitoring activities, including review and interpretation of adverse events and safety data, participation in safety review meetings, and collaboration with pharmacovigilance to ensure appropriate benefit–risk assessment for late-stage programs
Provide scientific input into investigator meetings, site feasibility and selection activities, and key study communications to ensure consistency and clarity across global trial sites
Mentor junior clinical scientists and contribute to the development of best practices, processes, and standards appropriate for a Phase 3–stage organization
Deliver on other related projects and initiatives as assigned, with flexibility to support evolving program needs in a growing biotechnology environment
Qualification
Required
Master's or Ph.D. in a relevant scientific discipline required; M.D. strongly preferred
6–10+ years of experience in clinical research, pharmaceutical, or biotechnology settings
Demonstrated experience supporting or leading Phase 3 clinical trials, including protocol development, data interpretation, and clinical study reporting
Prior experience in rare disease and/or ophthalmology drug development strongly preferred
Experience supporting regulatory interactions and late-stage clinical submissions (e.g., NDA/BLA/MAA components) highly desirable
Experience working in a cross-functional, matrixed environment typical of small to mid-sized biotech companies
Deep understanding of late-stage clinical development and the scientific and regulatory expectations for pivotal trials
Strong scientific judgment with the ability to independently assess data, identify risks, and propose solutions
Entrepreneurial mindset with comfort operating in a fast-paced, resource-conscious organization
Highly organized and detail-oriented, with a strong commitment to data quality, accuracy, and compliance
Excellent written and verbal communication skills, including the ability to clearly convey complex clinical data to internal and external stakeholders
Collaborative leadership style with proven ability to influence across disciplines without direct authority
Hands-on, proactive approach with a strong sense of accountability and urgency
Highest standards of professionalism, integrity, and ethical conduct
Preferred
Prior experience in rare disease and/or ophthalmology drug development strongly preferred
Experience supporting regulatory interactions and late-stage clinical submissions (e.g., NDA/BLA/MAA components) highly desirable
Benefits
Eligible to participate in group medical/dental/vision insurance plans
Short- and long-term disability plans
Life insurance
401(K) plan
Flexible time off policies and others
Company
Alkeus Pharmaceuticals, Inc.
Alkeus Pharmaceuticals, Inc.
51-200 employees
H1B Sponsorship
Alkeus Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
Funding
Current Stage
Growth StageTotal Funding
$150.1MKey Investors
Bain Capital Life Sciences
2023-06-05Series B· $150M
2011-10-24Grant· $0.1M
Leadership Team
Michel Dahan
President and CEO
Ilyas Washington
Co-Founder
Recent News
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