Lead integrated asset strategy across the full lifecycle, including research, clinical development, and commercialization.
Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
Ensure alignment across Clinical Development, Manufacturing, Quality, Regulatory, and Commercial teams for late-stage development and launch planning.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values like 'Stay True to Why' and 'Collaborate to Accelerate,' they are a committed team transforming autoimmune disease treatment.
Provide medical leadership and oversight of the lung cancer development program.
Lead clinical development subteams and design efficient clinical trials.
Contribute to global regulatory filings and health authority interactions.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. Its programs target the RAS/MAPK pathway, and it fosters a collaborative, mission-driven culture.
Lead and develop clinical operations teams, overseeing oncology trial execution from feasibility to closeout.
Drive process improvements and operational excellence to enhance study delivery and site performance.
Ensure compliance with regulations, manage budgets and resources, and foster stakeholder relationships.
The company is a global clinical development organization focused on advancing oncology therapies through clinical trials. It fosters a collaborative and inclusive work environment with opportunities for professional growth and continuous learning.
Manage operational activities for all phases of clinical studies, from start-up to close-out.
Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
Support data review, TMF maintenance, and cross-functional collaboration for trial success.
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.
Own the pharma/life science pipeline end to end: source, qualify, pitch, structure, close, and renew.
Carry the number and run the sales cycle across medical affairs, brand, market access, and procurement.
Partner cross-functionally with data, AI, and delivery teams to ensure deals ship.
Manta Cares is an AI patient platform that supports cancer patients and their families through every decision. The team brings over 50 years of combined healthcare experience and is backed by top-tier venture funds.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Provide strategic scientific leadership for clinical pharmacology across all development phases from Phase 1 through Phase 3.
Design and oversee clinical pharmacology studies, including PK/PD, exposure-response, and modeling and simulation activities.
Collaborate with cross-functional teams and support regulatory submissions to global health authorities.
Amylyx is a clinical-stage biotechnology company focused on developing therapies for diseases with high unmet needs, including ALS, Wolfram syndrome, and post-bariatric hypoglycemia. The company fosters a culture of caring with core values of audacity, curiosity, authenticity, engagement, and accountability, and has assembled an experienced team ready to tackle tough medical problems.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.