Senior Clinical Scientist

Alkeus Pharmaceuticals Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge Mass. Alkeus was founded in 2010 and since that time has been developing its lead compound gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD) a leading cause of blindness in the U.S.

Position Summary:

The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late-stage (Phase 3) clinical development programs in rare disease ophthalmology. This role plays a critical part in ensuring the scientific integrity regulatory readiness and successful execution of pivotal clinical trials intended to support global registration.

As a senior individual contributor the Senior Clinical Scientist serves as a core scientific partner across clinical development working closely with clinical operations biostatistics regulatory affairs and safety to translate strategy into executable high-quality Phase 3 studies. This role is well-suited for an experienced hire with demonstrated success in late-stage clinical development within rare disease and/or ophthalmology.

Primary 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 benefitrisk 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 3stage organization.

Deliver on other related projects and initiatives as assigned with flexibility to support evolving program needs in a growing biotechnology environment.

Qualifications:

• Education and Certification
  • Masters or Ph.D. in a relevant scientific discipline required; M.D. strongly preferred
• Work Experience
  • 610 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
• Skills and Key Success Factors:
  • 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

Other Relevant Information:

• Travel: Able to travel as assigned

Compensation

• Base Salary Range: $160K - $240K with the actual contingent upon several factors such as the selected candidates education/work experience/training and other factors (travel requirements etc.)
• Discretionary Bonus: 15% - 20% of Base Salary contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• 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. Eligibility and participation requirements vary by plan.

Alkeus Pharmaceuticals Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.