Lead DMPK and PK/PD strategy across discovery and development programs from candidate nomination through clinical development and regulatory submission.
Drive clinical pharmacology strategy including dose finding, exposure–response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs.
Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.
Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
With IT, defines our programming environment and its validation.
Responsible for the development of standards, SOPs, and best practices.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.
BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines for genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has a portfolio of 20+ drug development programs and offices in the US, Canada, and Switzerland, focusing on scientific excellence and rapid execution.
Act as strategic and operational partner to an Asset Entrepreneur, driving program execution end-to-end.
Synthesize scientific, clinical, and regulatory inputs into decisions for the C-suite.
Bring rigor to Board updates, investor discussions, and cross-functional coordination.
Enveda reads nature's chemistry with AI to discover new medicines ~4x faster than the industry standard. They reached unicorn status on a $150M Series D, have medicines in clinical trials, and are backed by Sanofi, Lux Capital, and Baillie Gifford.