Serves as a senior regulatory authority and trusted strategic partner to pharmaceutical and biotech C-suite executives, influencing enterprise-wide regulatory strategies.
Partners with the SVP & Practice Lead to shape the future direction of the Clinical & Regulatory practice, driving practice growth and translating regulatory landscape evolution into opportunities.
Proactively supports the practice's P&L, achieving annual revenue targets, leading pursuit strategies for high-value engagements, and setting delivery quality standards across the regulatory team.
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner, it brings together strategy, evidence, engagement, and technology to engineer breakthrough value for clients in the healthcare sector.
Translate program strategy into integrated timelines, milestones, and deliverables.
Manage one or more highly complex R&D programs and/or high-profile partnerships.
Lead cross-functional program management activities supporting autoimmune clinical development programs.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.
Drive alignment across teams and systems to ensure execution stays focused on the highest-impact work.
Own GTM program portfolio and prioritization, ensuring the highest-impact initiatives are prioritized, resourced, and executed.
Build and track metrics that connect system performance to business outcomes.
Fleetio provides a modern software platform that helps organizations worldwide manage their fleet operations. They are on an exciting trajectory as a company and are a proud founding member of the Rails Foundation.
Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
Own technical strategy and quality of Lumin’s SDK.
Build Lumin’s developer platform from the ground up.
Serve as Lumin’s technical face with external developers.
Lumin Digital is the digital banking platform of choice for credit unions and community banks. They are scaling their extensibility program, and are looking for a leader to make Lumin the best platform to build on in the community financial institution space.
Serve as the primary resource for internal AI initiatives, bridging Product, Engineering, Data, and GTM teams to prioritize high-impact opportunities and build the AI PD Operations roadmap.
Build and lead a high-performing AI PD Ops organization, designing and implementing AI-enabled workflow automations to reduce cycle times across Product Delivery teams.
Define and monitor AI adoption, performance, and ROI metrics while ensuring all tools and workflows align with governance, security, and compliance standards.
Engine is transforming business travel into something personalized, rewarding, and simple by building a platform that brings together corporate travel, a powerful charge card, and modern spend management in one place. The company is cash flow positive with rapid growth, supporting over 20,000 companies and 1 million travelers, and has been recognized as one of the fastest-growing travel and fintech platforms in North America with a culture of innovation.
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. They are known for delivering insights, products, and services that make quality care more accessible and affordable and foster a culture where employees can grow and make an impact.
Provide strategic leadership for biometrics across all clinical development programs.
Define and implement an integrated biometrics strategy supporting clinical trial design and data quality.
Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team and a strong financial foundation, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Develop and execute medical affairs strategies aligned with company goals.
Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations.
Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement.
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Every program reflects their commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
Lead a hematology program, overseeing all operational activities and strategic planning.
Provide leadership over CROs and vendors, ensuring timelines, quality, and budget expectations are met.
Collaborate with internal functional leads to drive integrated study execution, providing strategic direction.
Caribou Biosciences is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases using CRISPR genome-editing technology. They have a CAR-T cell therapy platform and headquarters in Berkeley, California.
Develop client-ready deliverables including protocols, statistical analysis plans, and technical reports.
Manage the delivery of project components by collaborating with other staff members.
Contribute to development of proposals and presentations under guidance of senior team members.
Precision Medicine Group is a portfolio organization that helps its clients with sophisticated evidence synthesis projects. The company has a start-up culture with vision in its field.
Define and own the multi-year software roadmap for the Genetics portfolio, ensuring alignment with clinical utility and revenue targets.
Operate as a "servant-leader" customer of the centralized Engineering organization, providing clear requirements and priorities to enable efficient technical execution.
Lead and mentor a specialized team of Product Solution Architects and Integration Engineers, fostering a culture of technical rigor and business empathy.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. They aim to make personalized genetic testing and diagnostics part of the standard of care. Natera consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, and software engineers from world-class institutions.
Lead the Learning team at Affirm, developing strategy and executing the design and delivery of solutions.
Partner cross-functionally with other teams to drive future programming and opportunities to grow employee capabilities.
Define, measure, and communicate relevant success metrics, demonstrating the value of Learning programs and investments.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. They focus on attracting talent, enabling growth, and retaining employees through thoughtful experiences and rewards for their 2500+ employees.