Study Director Jobs in Raleigh, NC (NOW HIRING)

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:

• Advance innovative science by pushing boundaries.
  
• Bring transformative therapeutics to patients in need.
  
• Provide an environment for employees to reach their fullest potential.
  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
  

Position Summary
The Director Pathology serves as the lead for Translational Medicine Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of AskBio's pipeline and reports to the Sr. Director, Pathology.
This individual will act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. The Director, Pathology will provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Additionally, they will frequently interact with internal and external colleagues to ensure timely and accurate dissemination of findings. The successful candidate will demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams.
Job Responsibilities

• Serve as the lead for Translational Medicine (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments
  
• Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions
  
• Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments
  
• Manage and provide scientific leadership to the internal staff and work closely with Discovery, Product Development, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals
  
• Advise and direct the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
  
• Represent Translational Medicine on discovery and development-IPT and EPT program teams
  
• Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs
  
• Maintain current knowledge of regulatory guidance, industry standards and recommendations
  
• Participates in selecting, developing and evaluating personnel to ensure efficient operation within the histopathology group
  
• Other pathology and translational medicine-related tasks as assigned
  

Minimum Requirements

• DVM with 6+ years of post-graduate experience in a pharmaceutical, biotech or academic organization
  

• Board certification in Veterinary Pathology (DACVP or ECVP)
  
• Previous experience working on programs that integrate pathological results to drive clinical development
  
• Experience with LIMS, digital/computational pathology platforms to characterize features from H&E and IHC images
  
• Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus
  
• Proven project management skills with the ability to manage multiple projects and priorities simultaneously
  
• Excellent communication skills (both oral and written) and collaboration skills with the ability to work effectively in a fast paced cross-functional team environment
  
• Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities
  
• Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs
  

Preferred Education, Experience and Skills

• Master's or PhD in a scientific discipline
  

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.