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.