The Director, FP&A will build and lead the company's financial planning and analysis function, serving as a key business partner to R&D and clinical operations. Responsibilities include owning the company-wide financial model, managing clinical and manufacturing budgets, and implementing new FP&A systems to support the transition to commercial operations.
The Senior Associate Specialist will manage day-to-day regulatory operations, including compiling, formatting, and submitting regulatory filings to the FDA CVM. They will also maintain submission trackers, manage document templates, and collaborate with internal teams to ensure regulatory compliance.
Provide Quality Assurance oversight for GMP manufacturing, release, and stability activities for veterinary pharmaceutical products. Manage batch disposition and quality events while collaborating with CDMOs and regulatory affairs to ensure compliance with cGMP and VICH guidelines.
Lead the analytical development and quality control strategy for oral solid dosage programs, overseeing method lifecycle management and regulatory submissions. Act as the primary technical point of contact for CDMOs and serve as the final scientific authority for OOS and atypical result investigations.
Lead end-to-end drug substance process development and manufacturing for small molecule APIs from early development through commercialization. Serve as the primary technical interface with CDMO partners and author CMC sections for regulatory submissions.
The COO will own the operational execution of the company's first commercial launch in 2027, managing Finance, People, Engineering, and Commercial functions. They are responsible for scaling the organization from 70 to 150 people using AI-leveraged efficiency and managing the internal operating cadence.
The Director will serve as the subject matter expert for FDA CVM regulatory strategy, leading clinical trial operations and agency interactions. They will oversee regulatory submissions, provide guidance on clinical studies, and manage a team to ensure compliance and strategic alignment.
