Build and lead field operations infrastructure for Definium's first commercial launch, including territory management, CRM workflows, and incentive compensation.
Partner with Commercial Analytics, Field Strategy, IT, and cross-functional teams to translate commercial strategy into reliable field processes.
Scale operations from pre-launch through commercialization while ensuring data integrity, compliance, and vendor oversight.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop treatments for psychiatric and neurological disorders. Headquartered in New York and trading on Nasdaq, the company is advancing a lean, collaborative culture focused on turning evidence into impact.
Implement and optimize REMS and specialty pharmacy workflows for COMP360 in the U.S.
Manage vendor relationships, compliance metrics, and cross-functional collaboration.
Support launch readiness, audits, and continuous process improvement.
Compass Pathways is a biotech developing COMP360 psilocybin for treatment-resistant depression and PTSD, with FDA Breakthrough Therapy designation. Headquartered in London with a U.S. office in New Jersey, it focuses on patient-centered mental health innovation.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Drive global PV Operations strategy, including planning, implementation, and management, in alignment with the Head of DSPV.
Oversee vendor oversight, case management, compliance, inspection readiness, and budget/resourcing.
Represent DSPV Operations to senior leadership, manage talent, and ensure global regulatory compliance.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, we foster a culture of empathy, owner's mindset, and urgency because patients are counting on us.
Drive the end-to-end stage-gate process, ensuring gate reviews and go/kill/hold decisions are documented.
Own a single master timeline for all product launches across retail, DTC, and Amazon.
Run the weekly product meeting and monthly portfolio review, keeping one system of record for all projects.
Javvy is a better-for-you beverage company creating café favorites with functional nutrition. It began as a DTC brand, rapidly scaled into an omnichannel business, and now expands into major retail with a collaborative, fast-paced startup culture.
Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
Own the Field Excellence operating model nationally, including cadence, standards, tools, and escalation protocols.
Serve as the single operational partner to the VP Sales, managing territory, IC questions, and business review preparation.
Manage and develop two Directors of Field Excellence and ensure launch readiness across all geographies.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies. The company is building its commercial infrastructure for a first US launch, with a mission-driven culture emphasizing integrity, collaboration, and commitment to people.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Partner with R&D and Commercial stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations.
Lead the transition from Veeva Vault RIM to Generis CARA, including scope, timeline, data migration, and vendor coordination.
Serve as system administrator for a portfolio of validated R&D and Commercial applications, ensuring compliance with FDA regulations.
Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. It is an end-to-end cell therapy company with centralized U.S. manufacturing serving thousands of patients worldwide, fostering a diverse and inclusive culture.
Lead a Professional Services team delivering Vault CRM across North America.
Drive operational excellence through hiring, performance management, and strategic initiatives.
Cultivate trusted customer relationships and collaborate across Veeva.
Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. It surpassed $3B in revenue as one of the fastest-growing SaaS companies and operates as a public benefit corporation with a flexible Work Anywhere culture.
Manage and maintain Virta's privacy compliance program, including policies, procedures, PIAs, and records of processing activities.
Act as primary point of contact for privacy inquiries from customers, prospects, and partners, supporting DPAs, BAAs, RFPs, and due diligence.
Drive cross-functional privacy initiatives, training, metrics, and incident response workflows to strengthen Virta's privacy posture.
Virta Health is on a mission to reverse metabolic disease in one billion people through virtual care, personalized nutrition, and technology. Backed by over $350 million from top-tier investors, the remote-first company partners with health plans and employers to help members restore their health.
Oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates.
Evaluate regulatory changes, coordinate product information revisions, and prepare Health Authority submissions.
Collaborate with cross-functional teams to maintain compliance with evolving regulatory requirements.
A global clinical research organization dedicated to improving patient outcomes through regulatory affairs and medicinal product compliance. It fosters a collaborative, patient-focused culture with opportunities for professional development.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Field-based role driving VTE therapy awareness and care pathway optimization across assigned hospital accounts.
Partners with physicians, nursing leaders, administrators, and cross-functional teams to advance clinical education programs.
Acts as regional marketing liaison, organizing events and sharing clinical data to support therapy adoption.
Penumbra is a global healthcare company headquartered in Alameda, California, focused on innovative therapies for challenging medical conditions. They offer a collaborative teamwork environment where learning is constant and performance is rewarded.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Lead the development and implementation of commercial field operations capabilities for a major pharmaceutical product launch.
Oversee field infrastructure, territory management, CRM workflows, incentive compensation, and performance reporting.
Collaborate with cross-functional teams including commercial, analytics, IT, finance, and compliance to ensure operational excellence.
A late-stage biopharmaceutical company advancing innovative treatments for psychiatric and neurological conditions. They offer a fast-paced, collaborative environment focused on building launch-ready capabilities.
Build trust with state healthcare regulatory boards and agencies to drive growth of the CE Broker solution.
Serve as the primary point of contact for assigned state partners, guiding operational efficiency and compliance.
Navigate multi-year government decision cycles with a consultative, relationship-first approach.
Propelus simplifies workforce compliance management across healthcare, providing technology and strategic partnerships that empower professionals, employers, and regulators. A trusted leader for over 20 years, the company serves millions with seamless compliance solutions and has been named a BuiltIn 2025 Best Places to Work.
Serve as drug product technical leader for formulation, process development, scale-up, and technology transfer via external CDMOs.
Apply Quality by Design principles to define CQAs, CPPs, and robust control strategies for inhaled dry powder products.
Lead CMC submissions, regulatory interactions, and commercial readiness activities including PPQ and PAI support.
Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing inhaled therapies for pulmonary diseases. It operates as a lean, collaborative team within the Roivant family, advancing a first-in-class candidate for PH-ILD through Phase 3 development.