Senior Medical Director, Clinical Development
Amylyx PharmaceuticalsFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Remote
Candidates must possess an advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) and have a deep understanding of rare disease, neurology, immunology, or a closely related field. Extensive knowledge of drug development processes, particularly late-phase trials, GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics is required. Demonstrated experience in drafting and reviewing protocols, regulatory documents, medical monitoring plans, and safety reports is essential, along with excellent scientific writing ability and meticulous attention to detail. Strong skills in data review, trend identification, data interpretation, and safety oversight, including experience with DSMBs/DMCs or other safety governance, are necessary. Effective communication, both written and verbal, with the ability to engage with internal teams, investigators, CROs, regulatory bodies, and external experts is crucial. A strategic mindset with the ability to balance long-term goals and tactical needs, along with experience working across geographies and multimodal teams, capable of influencing without direct authority, is also required. Proficiency in tools commonly used in clinical development is expected.
The Director/Senior Director, Clinical Development Scientist will serve as the scientific lead on assigned Phase III/late-stage trial(s), defining protocols and endpoints, authoring or reviewing regulatory-relevant documents, and ensuring protocol integrity and compliance. They will collaborate cross-functionally with clinical operations, biostatistics, regulatory, and safety teams to drive operational feasibility, site selection, study start-up, and execution across regions. Responsibilities include overseeing safety and efficacy data monitoring, identifying trends, supporting medical monitoring, working with DSMBs/DMCs, and ensuring timely reporting and regulatory compliance. The role involves supporting and contributing to the development and refinement of the overall Clinical Development Plan and associated evidence generation strategy. Maintaining and applying knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements relevant to the therapeutic area is key. Facilitating external relationships with sites, investigators, KOLs, CROs, and regulatory agencies is expected. The individual will provide mentorship, guidance, and scientific oversight to team members on scientific content and trial execution. Producing and supporting publications, presentations, and internal/external communications of trial findings and strategic insights is also part of the role. The position requires the ability to travel 15-20%.
Develops therapies for autoimmune diseases
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.