Senior Director, Clinical Development

About Alkeus Pharmaceuticals

Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.

Position Summary

This role is instrumental in driving the successful development and launch of innovative therapies to address unmet medical needs. The Senior Director of Clinical Development will lead and oversee clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives. The ideal candidate will bring experience in clinical trial design, execution, and regulatory interactions, with a particular focus on rare disease and small molecules.

Primary Responsibilities

• Lead and mentor high-performing clinical development teams, fostering a culture of excellence and innovation
• Lead the design, implementation, and oversight of clinical development programs from Phase 1 to Pivotal studies
• Develop and manage clinical development strategies aligned with company goals and regulatory requirements
• Represent the company in interactions with regulatory agencies, including FDA, EMA, and PMDA
• Oversee the day-to-day medical monitoring of clinical trials, including patient eligibility assessments, protocol waivers, and safety parameter reviews
• Manage and coordinate with Clinical Research Organizations (CROs) throughout the clinical trial process
• Provide medical and scientific expertise to support clinical development activities
• Manage pharmacovigilance activities, including adverse event reporting and safety update reports
• Lead and mentor clinical development team members
• Contribute to the preparation of regulatory submissions, including INDs, NDAs, and other required documentation
• Collaborate with cross-functional teams to ensure alignment of clinical development plans with overall product strategy

Qualifications:

• MD or MD/PhD, with strong academic qualifications and board certification in Internal Medicine required

Preferred Qualifications:

• Ophthalmologist

Work Experience

• 5+ years demonstrated clinical development experience in a pharmaceutical or biotechnology setting
• Knowledge of clinical development process and methods of scientific investigation, GCP, the FDA regulatory environment and guidelines, including study and protocol design
• Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies
• Demonstrate experience in clinical design and implementation of Phase 1 to Pivotal Clinical studies, with evidence direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines
• Sound medical/scientific writing skills and ability to analyze and interpret efficacy and safety data
• Direct experience in clinical development of small molecules
• Knowledge of statistical concepts as they relate to clinical plans
• Experience managing clinical CROs from RFP to statements of work to coordinating execution
• Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
• Knowledge in pharmacovigilance, including the receipt and processing of ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports
• Excellent problem solving, conflict resolution and team building
• Must demonstrate highly refined analytic and communication skills, and the ability to work effectively, both independently and in a team environment

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.
• 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
• Ability and aptitude to manage ambiguity and adaptability to change
• Emphasize the need for self-motivation and the ability to work independently

Other Relevant Information

• Travel: able to travel up to 25% of time

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 celebrate diversity and are committed to creating an inclusive environment for all employees.