Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry.
As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.
This position is responsible for developing and implementing quality assurance strategies, policies, and procedures to maintain the highest level of product and service excellence. Franklin Biolabs is seeking a visionary Head of Pharmacology and Toxicology to lead the pharmacology and toxicology team of this newly minted contract research laboratory. In this pivotal role, you will provide scientific leadership, management, and strategic direction, ensuring the delivery of top-quality nonclinical services for clients including the newly founded GEMMABio specializing in gene therapy products. Your expertise will be instrumental in guiding cross-functional teams and propelling Franklin’s mission providing high quality services to further client drug development.
Key responsibilities
- Lead and manage the Pharmacology and Toxicology unit, setting strategic vision and fostering talent development. Establish processes for mentoring & leading directors so that they can function independently within their unit.
- Line manage staff responsible for Nonclinical Study management (Study Directors), Nonclinical study operations, and Histopathology (Pathologist and Histology laboratory technical platform)
- Oversee all Pharmacology-Toxicology Unit operations. Manage resource allocation, budgeting, and operational planning. Provide strategic and operational leadership to establish streamlined/efficient processes which will improve turnaround times for the completion of studies to ensure customer satisfaction.
- Ensure high-quality and timely interim and final data reporting to clients; ensure customer satisfaction.
- Collaborate with other Unit Heads by planning, formulating and communicating objectives, creating a shared vision, collaborations, and maintaining consistency of procedures across teams and locations.
- Oversee the preparation of clear and concise data slides summarizing the work of your unit; conduct cross-functional regular meetings to overview the performance of the departments under your remit, monitor progress. Make decisions either independently or after proper escalation to the C suite when needed. Ensure decisions are efficiently communicated to the pertinent stakeholders
Qualifications
- MD, DVM or equivalent
- Ph.D.
- 10+ years of relevant histopathology and toxicology experience, including Pharma, Biotech and/or CRO experience.
- Board certified by the American Board of Toxicology (ABT) and/or American College of Veterinary Pathologists (ACVP), European College of Veterinary Pathology (ECVP) or Japanese College of Veterinary Pathology (JCVP).
- Proven management capabilities.
- Knowledge and experience in GLP and other applicable regulatory requirements
- Familiar and comfortable with preclinical safety assessment strategies for various drug products, including but not limited to gene therapy products, small molecules or other biologics.
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office Suite or related software, and with Xybion or other related nonclinical study data capture software.
Application note
Franklin Biolabs is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Franklin Biolabs via email, the Internet, or directly without a valid written search agreement for this role will be deemed the sole property of Franklin Biolabs and no fee will be paid in the event the candidate is hired
