Aldeyra Therapeutics, Inc.
It is an exciting time to join Aldeyra Therapeutics, with several late-stage programs, NDA submissions in the near term, and numerous pipeline programs in various indications. Additionally, given Aldeyra’s RASP platform and broad therapeutic potential, the company seeks to recruit a Senior Medical Director with the necessary skills to carry out the company’s drug development programs. This individual will provide strategic and tactical clinical development leadership necessary to further advance Aldeyra’s pipeline and clinical trials.
• Plan and design of clinical studies, in addition to the development of clinical plans in accordance to corporate objectives
• Medical Lead and/or Medical Monitor during clinical studies at various stages of development; Includes clinical oversight and medical review of clinical trial data in collaboration with the clinical operations.
• Directing the development, presentation, and publication of clinical data on the company’s therapeutic candidates, ensuring the highest quality and consistency with corporate strategy;
• Medical writing of clinical sections in regulatory documents not limited to IND submission, IND annual updates, briefing documents, study protocols, investigator brochures, and other study-relevant documents like patient informed consent documents;
• Manuscript writing of publications or other documents intended for external audiences;
• Supervision of external consultants and SAB if applicable;
• Primary point of contact for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input;
• Review safety data for clinical detection and prepare safety charters, DMC charters, or other specific management plans or manuals in a cross-functional team if not the primary author;
• Support or preparation of data interpretation and clinical trial reports;
• Together with Clinical Operations preparation of Investigator Alert letters and SAE reports as required;
• Medical affairs activities as needed;
• Monitor departmental compliance with required training and adherence to all corporate and departmental SOPs, GCP/ICH guidelines, and QC/QA procedures
• M.D.; additionally, a Ph.D. is desired, though not a definitive requirement
• 5-10 years of biotech/pharmaceutical/clinical experience and knowledge of the drug development process with 3+ years in clinical development
• Experience working with medical monitors, R&D functions, regulatory affairs, quality assurance, thought leaders, and clinical investigators
• Experience with managing multiple clinical studies in diverse indications
• Experience with drug development within the pharmaceutical or biotechnology industry, particularly in systemic inflammatory diseases, rare diseases, ophthalmology, and/or oncology clinical studies
• Demonstrated expertise with developing and implementing biomarkers and translational medicine strategies in early and late-stage clinical development and mechanistic profiling programs
• Experience with regulatory submissions, including IND and NDA submissions
• Ability to think strategically and creatively, function independently, deliver on timelines, and detailed knowledge of the activities and procedures involved in clinical drug development
• Strong ability to work collaboratively in a matrix environment and the ability to foster relationships
• A thorough understanding of ICH, GCP, and relevant regulatory requirements
• Ability to travel 20%
Leadership and Communication:
Excellent written and verbal communicator and can facilitate/articulate recommendations and critical decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across company.
Ability to develop new business relationships and to nurture partnerships with internal and external stakeholders. Ability to provide strong cross-functional team leadership to maintain alignment and to set and meet collaborative operational goals.
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