Associate VP, Regulatory and Clinical Affairs
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Accentuate Staffing is partnering with a cutting-edge biotechnology company who is hiring for an Associate VP of Regulatory and Clinical Affairs in Organ Manufacturing. This is a direct hire opportunity, offering competitive pay, benefits, stock options and cash bonuses. The ideal candidate has the ability to leading, developing, and implementing the regulatory and clinical strategy for FDA approval of 3D-printed transplantable solid organs, including lung, kidney, and liver.
Responsibilities:
- Leading the development and execution of the regulatory and clinical strategy for FDA approval of manufactured organs, as well as all FDA interactions.
- Leading regulatory compliance efforts for GLP pre-clinical, GMP manufacturing, quality management, and clinical studies.
- Responsible for the design, implementation and reporting of clinical trials that meet the highest standards of excellence for ethics, scientific merit, and regulator’s compliance, as well as satisfy corporate goals for approval of the product.
- Develop an integrated clinical strategy leading to FDA approval of 3D printed organs, while simultaneously having the judgment to prioritize activities, improve processes and meet timelines.
- Provide oversight of clinical study execution in collaboration with Organ Product Development and all members of the clinical study team.
- Build and lead a regulatory and clinical affairs team of 3-5 people.
Requirements:
- Degree in a related Scientific field.
- 10+ years of experience in the Cell Therapy or Pharma industry OR combination of relevant education and experience.
- 4+ years of management experience, leading and managing a team.
- Direct experience implementing and developing regulatory strategy for IND?CTA-MAA programs.
- Proven ability to manage clinical development programs from nonclinical through Phase 3.
- Knowledge of biologics/drug development process form pre-IND through registration and post-registration.
- Experience working with external CROs and CDMOs.
