Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Lead late-stage drug substance process design, optimization, and scale-up across global CDMOs.
Embed Quality by Design and DoE to define CPPs/CQAs and support regulatory submissions.
Drive tech transfer, PPQ campaigns, and cGMP compliance for commercial readiness.
Pulmovant is a Roivant-backed clinical-stage biotech developing inhaled therapies for pulmonary diseases. Its lead candidate, mosliciguat, is in Phase 3 for PH-ILD, and the company operates with a collaborative, fast-paced Roivant culture.
Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.
Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.
Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.
Lead formulation and process development for inhaled dry powder products through scale-up and commercialization.
Apply Quality by Design principles and statistical tools to ensure product quality and regulatory compliance.
Collaborate with cross-functional teams and external CDMO partners to deliver CMC milestones and regulatory submissions.
Pulmovant is a biotechnology company developing inhaled dry powder therapies for serious pulmonary diseases. It is a lean, collaborative organization focused on bringing innovative treatments to patients with significant unmet medical needs.
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.
Lead vendor sourcing, contracting, and oversight for clinical development programs Ph I-IV.
Drive outsourcing strategies and ensure external partners meet timelines and quality.
Collaborate with Legal, Finance, and study teams to negotiate and execute contracts.
A biotechnology company driving clinical development programs with external partners. The environment is fast-paced and collaborative, with an emphasis on cross-functional teamwork and continuous improvement.
Partner with the Asset Entrepreneur to anticipate program inflection points and model backup scenarios.
Own program execution end-to-end, operating as the COO of a single-asset biotech.
Translate complex scientific, clinical, and regulatory inputs into clear options for the Board and C-suite.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. With over $845M in funding and a $2B valuation, it has three oral medicines in the clinic and is recognized as a top startup employer.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
Lead the development and execution of clinical development plans for exploratory and biopharmaceutics programs.
Oversee global clinical trial operations, including timelines, budgets, vendors, and cross-functional collaboration.
Drive risk management and strategic decision-making across the molecule lifecycle.
The hiring company is a pharmaceutical organization focused on clinical development and biopharmaceutics. It values learning agility, innovation, inclusion, and collaboration in a virtual and matrixed environment.
Lead vendor sourcing, contracting, and governance for assigned clinical programs.
Partner with study teams and external vendors to ensure successful outsourcing execution.
Manage vendor agreements, performance, and issue resolution across Phase I-IV studies.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is an early-stage biotech launched with assets from Paragon Therapeutics, fostering a fast-paced and collaborative environment.
Lead statistical programming activities for Gene Therapy clinical trials from start-up through database lock, analysis, and reporting.
Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures in compliance with CDISC standards.
Collaborate with Biostatisticians and cross-functional teams to support regulatory submissions and manage study-level deliverables.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, we offer a supportive culture, continuous training, and a strong commitment to diversity and inclusivity.
Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.
Support clinical development strategies and study execution across Phase 1-3 programs.
Oversee clinical safety and data review, partnering with CROs and internal teams to ensure quality.
Contribute to protocols, regulatory documents, and study reports for respiratory disease therapies.
Celea Therapeutics is a biopharmaceutical company dedicated to advancing transformative treatments for serious respiratory diseases, with its lead program in Phase 3 clinical development. As an early-stage, mission-driven team, Celea values accountability, transparency, collaboration, innovation, and passion.
Lead and oversee global Phase 0-4 clinical trials with cross-functional teams from inception to closure.
Manage external vendors, recruitment strategies, and study systems to ensure quality, efficiency, and inspection readiness.
Collaborate with study project managers to drive timelines, budgets, and compliance with ICH/GCP and AbbVie policies.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and Allergan Aesthetics. They are a global, science-driven pharmaceutical company committed to integrity, innovation, and serving the community.
Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
Provide statistical programming support across oncology programs.
Oversee and review the quality of CRO programming deliverables.
Create, review, and validate SDTM, ADaM, and TFLs.
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by developing medicines for serious infectious diseases and cancer. The company emphasizes a supportive, collaborative culture where colleagues' success drives its mission.
Build and deploy models and digital tools that support drug substance, drug product, packaging, and labeling processes.
Partner with technical teams and CDMOs to turn process data into predictive models and analytics for phase-appropriate decisions.
Develop reusable data products and dashboards in Databricks, applying AI/ML to accelerate CMC data review.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. It fosters a culture of trust, ownership, curiosity, and results while developing high-impact medicines.
Lead chemistry efforts on cross-functional project teams to drive PROTAC programs from inception to clinical candidate nomination.
Design molecules with optimized potency, selectivity, and pharmacokinetic properties, focusing on degrader-antibody conjugates.
Collaborate with computational chemistry, CROs, and cross-functional partners to analyze SAR and inform strategic decisions.
Arvinas is a biotech company developing therapies that degrade disease-causing proteins via its proprietary PROTAC platform. It is a passionate, curious team headquartered in New Haven, CT, driven to improve patients' lives.