Provide strategic leadership and operational oversight for clinical trial design, analysis, and reporting.
Build and mentor a high-performing clinical biostatistics team while driving regulatory submissions.
Partner with cross-functional teams and vendors to ensure high-quality statistical and data management support.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than industry standard. With over $845M in total funding and a $2B valuation, the company is recognized as a top startup employer and has three oral medicines in the clinic.
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.
Serve as sponsor medical monitor on clinical trials, overseeing eligibility, causality assessment, and medical judgment calls.
Write medical monitoring plans, own protocol safety rules, and contribute to investigator's brochures and study reports.
Build and lead the in-house medical monitoring team as trials move in house, defining roles and hiring.
Enveda is a clinical-stage, AI-enabled biotech company discovering medicines from nature four times faster than industry standards. With over $845M in total funding and a $2B valuation, they have three oral medicines in the clinic and are recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.
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.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
Drive go-to-market strategy to increase adoption of Veeva Payments among life sciences companies.
Engage with customers as a trusted advisor, articulating the value of a connected payments solution.
Support sales teams by educating customers and driving strategic sales cycles.
Veeva Systems is a mission-driven industry cloud pioneer helping life sciences companies bring therapies to patients faster. As a fast-growing public benefit corporation with over $3B in revenue, we are committed to customer and employee success.
Lead advertising review process improvements and develop scalable workflows for compliance.
Review advertising and promotional claims across multiple channels for FDA, FTC, and consumer protection compliance.
Partner with Growth, Creative, and Clinical teams to streamline reviews and support timely campaign launches.
Ro is a direct-to-patient healthcare company offering nationwide telehealth, labs, and pharmacy services. It has helped millions of patients since 2017 and is recognized as a top workplace in healthcare and New York.
Set the strategic direction and long-term roadmap for Extend's regulatory compliance program, spanning licensing, service contracts, and insurance.
Serve as the executive-level owner for regulatory and licensing matters, representing compliance in front of regulators and auditors.
Partner with cross-functional teams to embed compliance requirements into merchant onboarding, customer experience, and product workflows.
Extend provides AI-driven solutions for retailers to enhance post-purchase customer satisfaction and drive revenue growth. The company works with more than 1,000 merchant partners, is backed by prominent technology investors, and is headquartered in downtown San Francisco.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career 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.
Develop and execute regulatory strategies that support project development, power access, and market expansion.
Represent Tract before FERC, state public utility commissions, ISOs, and legislative bodies through advocacy and stakeholder engagement.
Analyze retail and wholesale electricity market rules and translate implications into clear commercial guidance.
Tract is a team of digital infrastructure experts accelerating responsible data center growth by developing master-planned parks with pre-positioned power and fiber. Headquartered in Denver, Colorado, the company has real estate holdings throughout the United States and is a growing team committed to collaboration with communities.
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.
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.