Lead cross-functional project teams for 503a and 503b sterile product launches, from ideation through R&D to commercial launch.
Lead expansion and continuous improvement workstreams that support 503a and 503b sterile product development.
Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.
Hims & Hers is a health and wellness platform committed to making people feel great through better health by delivering affordable and personalized care. They are a public company traded on the NYSE under the ticker symbol “HIMS” with a talent-first flexible/remote work approach.
Supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission.
Takes a leading role in analytical characterization activities in support of comparability studies, heightened characterization studies, method development, control strategy development.
Supports preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They are a team of problem solvers dedicated to pursuing bold scientific approaches and have a collaborative spirit, breeding a culture where everyone feels inspired.
Attend multi-disciplinary team meetings, representing the statistical programming function.
Review and approve SAPs and TFL shells before the start of programming outputs
Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer, particularly solid tumors. The company's lead candidate, gedatolisib, is in Phase 3 clinical development and they also have ongoing Phase 1b/2 trials.