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Establish and manage a risk-based quality strategy and audit program for clinical development and pharmacovigilance activities. Lead inspection readiness for global health authorities and oversee the quality management system, including SOPs and CAPAs.
Requires a bachelor's degree in a scientific or medical field and at least 10 years of pharmaceutical industry experience, with 5 years specifically in quality. Must have deep knowledge of ICH-GCP, GVP, and FDA regulations, with a willingness to travel up to 30%.
The Director of Clinical and Pharmacovigilance Quality is responsible for participant safety, data integrity, and global regulatory compliance across the Company's clinical development and pharmacovigilance activities. Operating in a lean, fast-paced biotech environment with multiple concurrent Phase II and Phase III studies across global geographies and a heavily outsourced CRO and vendor model, this leadership role establishes and manages a risk-based quality strategy; oversees GCP and GVP compliance across investigator sites, CROs, and safety vendors; leads inspection and marketing-application readiness; drives quality governance, metrics, and continuous improvement; and serves as a hands-on strategic quality partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory, and Data Management.
Responsibilities
Requirements
The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $200K – $215K
The Values We Hope You Share
Purpose Driven– We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments. We set competitive company goals to significantly and positively impact the lives of our patients, employees and shareholders. We have a sense of urgency to every action we make.
Transparent – We trust each other and expect honest and open communication to enable good decision making. We are humble, genuine and direct. Words match our behaviors. We hold each other accountable. We embrace the tough conversations to achieve success.
Bold – We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
Intelligent – We are curious, passionate and self-aware. We are agile, adaptable and seek diverse experience, knowledge, and skills to make informed, data driven decisions. We anticipate the needs of others, and we adapt quickly to challenges and find solutions. We rely on our collective experiences to diligently develop, strategically plan and efficiently execute our vision.
Unified – We collaborate as we strive for excellence. We rely on each other, and we have each other’s backs. We encourage constructive feedback to continually improve. We support each other; we laugh together. We celebrate each other’s successes and band together in times of hardship. We foster and appreciate genuine relationships.
Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
Offices: New York, New York 10022, US
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