Senior Director/Executive Director, Pharmacology/Toxicology

Senior Director/Executive Director, Pharmacology/Toxicology

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues.  Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

Reporting to the SVP, Translational Science the Senior Director/Executive Director, Pharmacology /Toxicology will lead the Pharmacology Toxicology function within Translational Science.  The role will be responsible for coordinating, analyzing and reporting on animal pharmacology, pharmacokinetic, and toxicology studies aimed at proving safety and efficacy of candidate products for gene therapy of neuromuscular diseases. Additionally the role includes responsibility for study data management/ cross-department presentation of relevant data, coordinating animal studies and corresponding report writing.

Responsibilities

• Be an active member of the translational leadership team with shared responsibility for developing and implementing the Company’s translational research pipeline.
• Lead a team of scientists in Pharmacology/Toxicology to advance Company’s gene therapy pipeline.
• Develop overall toxicology strategy for each program assigned.

• Ensure nonclinical studies are managed and executed within budget and in accordance with established timelines.
• Design nonclinical studies and ensure that they are conducted in compliance with relevant SOPs, regulatory requirements, Good Laboratory Practices and the highest quality standards.
• Evaluate data quality and study progress on an ongoing basis, inform management of potential issues, develops solutions and works with the team on corrective action plans.
• Oversee the selection and management of nonclinical vendors. Negotiate contracts and budgets with sites and vendors.
• Ensure appropriate maintenance of nonclinical documents.
• Liaise with other departments to coordinate and plan for the availability of nonclinical supplies necessary to meet study requirements.
• Represent Pharmacology Toxicology on cross-functional project teams for strategic planning, risk/benefit assessments and achievement of company, project and team goals.
• Develop and continually improve departmental infrastructure including development of SOPs.
• Travel up to an average of 20% to partners and vendors.

Required Qualifications

• 15+ years in the biotech/pharmaceutical industry with BS in Pharmacology/Science or 12+ years with MS in Pharmacology/Science in or 10+ years with PhD in Pharmacology/Science.
• Exceptional leadership skills; 5+ years of experience managing Scientists and Research Associates in industry.
• Demonstrated experience coordinating conduct of in vivo studies.
• Experience in pharmacokinetics, toxicology and animal pharmacology/monitoring animal studies.
• Successful experience writing/reviewing regulatory sections of IND.
• In depth experience managing CROs to achieve nonclinical milestones on time and within budget.
• Comprehensive knowledge of the drug development process including cross functional integration from POC through Phase I.

• A transparent, flexible, can-do approach to address issues innovatively and proactively to promote teamwork and a pleasant work environment.
• Outstanding influencing, oral and written communication skills.
• History of success working with all levels in dynamic fast paced hands on environment.
• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred Qualifications

• Experience with rare diseases, neuromuscular diseases and/or gene therapy products.
• Experience in a small company and high growth, fast-paced environment.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.