Director of Clinical Development & Regulatory Affairs
📋 Role Overview & Responsibilities
Company Description
Targazyme Inc. is a phase 3 ready (FDA phase 3 Special Protocol Assessment in place) clinical-stage biopharmaceutical company based in San Diego with a cell efficacy multiplier platform technology and multiple products to address serious unmet medical needs for patients with cancer and auto-immune diseases. Our products include our phase 3 ready TZ 101 HSCT, phase 1/2 ready FucoTIL and phase 2 ready FucoTregs.
Role Description
Note the company is currently raising its pre-IPO Mezzanine Financing. Post financing, a market based compensation structure will be in place. Pre-financing, the compensation will be heavily weighted towards equity, bonuses, success fees.
This is a full-time on-site/hybrid position in San Diego, CA We are looking for a fast-paced, execution/resulted oriented, resourceful, multi-tasking Director of Clinical Development & Regulatory Affairs will be responsible for leading clinical development, regulatory strategy, safety, and compliance for our enzyme-based platform technologies. The Director of Clinical Development & Regulatory Affairs will also be responsible for implementing clinical trials, working with regulatory authorities, partnering with external consultants, and forging partnerships with various stakeholders.
Qualifications
PhD, MD, or equivalent advanced degree in life sciences or related fieldGreat at executing clinical development and regulatory strategy, with demonstrated success in obtaining multiple regulatory approvals for biologic productsExperience managing clinical trials and partnering with regulatory authorities, external consultants, and other stakeholdersStrong knowledge of GCP, GLP, and FDA regulations, as well as relevant international regulatory environmentsDemonstrated leadership, strategic thinking, and communication skills, as well as a passion for improving clinical outcomes for patientsExperience in immunology, cell therapy, gene therapy, or regenerative medicine a plusAbility to work in a fast-paced, team-oriented environment with a sense of urgency and commitment to excellence
Frequently Asked Questions
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This position is located in San Diego, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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