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.
Enveda is reinventing drug discovery by harnessing nature's intelligence to identify new medicines four times faster than the industry standard. The company achieved unicorn status following a $150 million Series D funding round in 2025 and has been recognized by Newsweek, Forbes, and Fast Company for its award-winning culture.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Build and lead the US Field Medical Affairs organization, including hiring and managing a high-performing MSL team.
Implement field strategy in alignment with clinical development and launch plans, and oversee MSL training and analytics.
Collaborate internally and externally, track KPIs, and ensure compliance with regulations while engaging key opinion leaders.
The job posting states: 'Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.'
Provide clinical development leadership at the study level for clinical stage assets in early and/or late development.
Serve as medical monitor for one or more studies and perform ongoing clinical trial data review.
Contribute to clinical development strategy and author clinical and regulatory documents.
Deciphera is a biopharmaceutical company focused on developing new medicines to improve the lives of people with cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
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.
Lead the biometrics team including statisticians, data managers, and statistical programmers at a program level, providing strategic input for clinical development.
Author and develop Statistical Analysis Plans (SAPs), contribute to trial designs, protocol development, and sample size calculations, and oversee vendor deliverables.
Interact with global health authorities, contribute to regulatory submissions, and coordinate statistical analyses for safety updates and ad hoc requests.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation long-acting antibodies to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. As a growing company, they offer a fast-paced, dynamic environment where you help shape the culture and contribute broadly to meaningful medicines.
Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
Identify common tasks and problems where AI can add value in pharmacology workflows.
Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.
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.
Lead integrated asset strategy across the full product lifecycle, from research through commercialization.
Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
Partner cross-functionally with Research, Clinical, Regulatory, and Commercial teams to ensure alignment and execution.
Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values, the company is committed to transforming treatment for autoimmune disease.
Identifies and closes business opportunities for biospecimen services.
Develops and maintains strong client relationships to expand existing business.
Manages a team of Business Development Directors and guides training and strategy.
Precision Medicine Group provides biospecimen services to pharmaceutical and biotech companies. The company emphasizes collaboration, client relationships, and innovation, with a team of experts supporting business development.
Lead US commercial strategy development and alignment with enterprise priorities.
Build integrated portfolio prioritization and governance capabilities for the US business.
Drive strategic execution, insights, and performance tracking for the US Leadership Team.
Novartis is a global healthcare company focused on innovative medicines. They employ over 100,000 people and emphasize a collaborative culture dedicated to improving patients' lives.
Co-own Tiny Health's clinical evidence roadmap and define study objectives aligned with product and regulatory goals.
Lead the design and publication of observational, interventional, and real-world evidence studies, including protocol development and statistical analysis plans.
Partner with cross-functional teams to ensure analytical rigor, translate findings into defensible claims, and present results to internal and external audiences.
Tiny Health advances lifelong health through precision microbiome science, addressing chronic disease from the first 1,000 days to the last. Founded in 2020 by microbiome scientists and physicians, the company is a remote-first team of about 30-50 employees with a culture of high standards, transparency, and continuous learning.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Provide program management expertise and leadership for novel engineered T cell therapies, managing cross-functional development programs.
Drive execution against critical path activities, track milestones, and communicate risks to senior leadership.
Influence cross-functional stakeholders to align on priorities, resolve conflicts, and support governance forums.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a rapidly growing company driven by core values of innovation and collaboration.
Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.
Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.
Lead and develop a team of Solution Sellers to drive growth across digital engagement solutions for small and emerging biopharma segments.
Define and optimize go-to-market strategies, collaborating with product and analytics teams to shape segment-specific offerings.
Serve as a strategic advisor to clients and represent IQVIA Digital at leadership meetings and industry events.
IQVIA Digital provides omnichannel marketing solutions and healthcare technology for the life sciences industry. IQVIA is a large global organization with a collaborative culture focused on improving patient outcomes.
Serve as subject matter expert defining gold standard for AI-generated clinical content.
Share knowledge about day-in-the-life working with data for regulatory submissions.
Identify realistic sources of variance or data corruption in study data.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a small team of top researchers and engineers across AI and biology to build an AI scientist.