Medical Director, GDNF

Ask Bio 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.

Ask Bio’s gene therapy platform includes Pro
10, 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

Minimum Requirements
* MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years’ relevant work experience
* Completion of clinical training with demonstrated clinical experience; board certification or eligibility in Neurology or a closely related specialty
* Minimum of 3 years of industry experience or related experience in clinical research or clinical development within the pharmaceutical, biotechnology, medical device, CRO/CDMO, or closely related academic or translational research setting
* Direct experience contributing to the design and execution of clinical trials, including protocol development and clinical data review
* Demonstrated working knowledge of Good Clinical Practice (GCP), including clinical monitoring, safety oversight, and data quality standards
* Experience supporting inspection readiness activities, including preparation for or participation in FDA or other health authority inspections, audits, or internal quality reviews
* Ability to independently perform the core duties of a Medical Director in a regulated drug development environment
* Ability to provide medical oversight for FDA inspection readiness, including review of key trial documentation, monitoring outputs, and safety narratives
* Experience reviewing and interpreting monitoring reports, audit findings, protocol deviations, and CAPAs
* Strategic oversight of risk-based monitoring and trial quality management approaches
* Understanding of gene therapy–specific safety risks, including delayed adverse events and durability considerations requiring extended follow-up
* Strong analytical and problem-solving skills applied to clinical, safety, and compliance issues
* Excellent written and verbal communication skills, including interaction with senior leadership and regulatory agencies

Preferred Education, Experience and Skills
* Prior experience in CNS, neurology, or movement disorders clinical development
* Experience with gene therapy, cell therapy, or other advanced therapeutic modalities
* Experience…