Medical Director

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.

We areseekingahighly motivated and collaborative physician to join our Clinical Development team as Medical Director.

Position Summary

TheMedical Directorwill play a key role in the medical oversight and execution of clinical trials supporting the development of therapies for retinal diseases with primary responsibility for the companys Phase 3 clinical program andadditionalcontributions to ongoing Phase 2 trials.

Working closely with the Vice President of Clinical Development and the broader cross-functional development team the Medical Director will provide medical and scientific leadership across clinical trial design execution safety oversight and interpretation of clinical data. This individual will collaborate closely with clinical operations biostatistics regulatory affairs pharmacovigilance and medical affairs to ensure the successful conduct of high-quality clinical studies aligned with regulatory expectations and company strategy.

Primary Responsibilities

• Provide medical leadership and oversight for clinical trials withprimaryfocus on the companys Phase 3 development program andadditionalsupport for Phase 2 studies.

• Contribute to the design development and implementation of clinical study protocols including endpoint selection patient population definition and statistical considerations in partnership with cross-functional teams.

• Serve as a key medical representative on clinical study teams providing input throughout study planning execution data review and interpretation.

• Leadmedical monitoring activities for clinical trials including review and interpretation of safety data adverse events and emerging clinical findings.

• Collaborate closely with clinical operations to ensure clinical studies are executedin accordance withprotocol timelines quality standards and regulatory requirements.

• Work with biostatistics and data management teams to support statistical analysis plans data review activities and interpretation of clinical trial results.

• Contribute to regulatory submissions and interactions with global health authorities including preparation of clinical sections of regulatory documents briefing materials and responses to regulatory inquiries.

• Lead or contribute to the preparation of clinical study reports investigator brochures regulatory filings publications and presentations of clinical data.

• Engage with key opinion leaders investigators and academic collaborators to support study design scientific exchange and clinical program advancement.

• Participate in investigator meetings advisory boards and scientific conferences as a medical representative of the company.

• Collaborate cross-functionallywith regulatory affairs pharmacovigilance clinical operations biostatistics medical affairs and commercial teams to ensure alignment across development activities.

• Provide mentorship and scientific guidance to clinical development team members asappropriate.

• Deliver on other related projects and initiatives as assigned in support of the companys clinical development programs.

Qualifications

• MD or equivalent medical degreerequired

• Board certification or specialty training in Ophthalmology preferred

• Subspecialty training or experience in retina highly desirable

Work Experience

• 58 years of experience in clinical research or drug development within the pharmaceutical or biotechnology industry

• Demonstrated experience supporting clinical trials including Phase 2 and Phase 3 studies

• Experience in ophthalmology retinal diseases or rare disease drug development strongly preferred

• Experience contributing to regulatory submissions and interactions with health authorities (e.g. IND NDA/BLA components)
• Experience working within a cross-functional matrixed environment typical of biotechnology companies

Skills and Key Success Factors:

• Entrepreneurship spirit with a passion to build learn and evolve with the team
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills with experience translating complex concepts for various audiences
• Demonstrated record of intellectual curiosity innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of hands-on experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highest levels of professionalism confidence personal values and ethical standards

Other Relevant Information:

• Travel: Able to travel asto support clinical trials investigator meetings and scientific conferences

Compensation

• Base Salary Range: $250K - $300K with the actual contingent upon several factors such as the selected candidates education/work experience/training and other factors (travel requirements etc.)
• Discretionary Bonus: up to 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.