Source Job

• Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
• Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
• Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.

• Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
• Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
• Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.

Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.

• 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.

• Develop and implement global CMC regulatory strategies for biologic and combination products.
• Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
• Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
• Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
• Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.

BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.

• Lead product-level biostatistics tasks including regulatory interactions and filings, ensuring statistical integrity.
• Contribute to study design, sample size determination, and author/review statistical analysis plans and TFL specifications.
• Mentor junior team members and collaborate cross-functionally to meet product deliverables and timelines.

Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. The company fosters a supportive, inclusive culture emphasizing learning and growth, enabling employees to thrive professionally and personally.

• Provide statistical oversight and lead complex programs such as NDA/BLA/MAA submissions.
• Consult with clients on clinical trial study design and regulatory strategy.
• Author statistical analysis plans and review statistical output for accuracy.

Precision Medicine Group provides statistical leadership and support for clinical development, consulting with clients on trial design and regulatory strategy. The company is a global organization that values collaboration, service, and accountability, fostering a culture of mentoring and innovation.

• 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.

• Provide strategic leadership and medical expertise for clinical development of antibody portfolio in IBD.
• Lead ongoing Phase 2 platform study and shape registrational program.
• Drive cross-functional collaboration and regulatory interactions for global submissions.

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology. It is a young, fast-paced company with a high-growth environment, focused on advancing antibody therapeutics for IBD.

• Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
• Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
• Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.

Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.

• 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.

• Accountable for translational development strategy from drug candidate through IND submission and Phase 1 entry.
• Support biomarker strategies, indication selection, and patient stratification to guide program decisions.
• Lead IND-enabling activities, author regulatory documents, and serve as translational science lead in FDA interactions.

We are a small, driven biotech company using Nobel Prize-winning click chemistry to develop targeted cancer therapies that activate potent drugs only at the tumor site. We are a remote-first team encompassing broad backgrounds, united by a mission to make cancer treatments more effective with minimal side effects.

• Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
• Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
• Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.

We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.

• Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
• Write and manage investigational regulatory submissions for US, EU, and ROW.
• Support risk mitigation and GMP compliance across development programs.

Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.

• Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
• Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
• Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.

Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.

• Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
• Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
• Represent regulatory on study teams and maintain knowledge of US and international regulations.

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.

• Lead and personally execute biologics CMC consulting engagements as the primary technical point of contact across program lifecycle.
• Establish and grow Syner-G's presence in the West Coast biologics market, focusing on Bay Area, San Diego, and Seattle biotech corridors.
• Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, and CMC regulatory strategy.

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and delivery of life-enhancing therapies. The company has been honored with BioSpace's prestigious 'Best Places to Work' award for three consecutive years, fostering a culture focused on career growth, development opportunities, and financial rewards.

• 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.

• Provide physician-level medical oversight for early-phase clinical trials, ensuring participant safety through screening, eligibility review, and real-time clinical decision-making.
• Participate in Safety Review Committee meetings and dose-escalation decisions for first-in-human and ascending dose studies.
• Review study protocols, informed consent forms, and safety monitoring plans, and serve as medical liaison during audits and inspections.

Celerion is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-human studies. They partner with pharmaceutical and biotechnology sponsors to advance new therapies, and emphasize integrity, trust, teamwork, and respect as core values.

• Lead a 6-person MSL team in Plastics & Regenerative Medicine while maintaining a personal field territory.
• Ensure scientific engagement plans align with brand strategy and medical objectives.
• Provide coaching, training, and performance management to the MSL team.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates globally in immunology, oncology, neuroscience, and aesthetics.