VP, GDNF Clinical Development

AskBio Inc.

Vice President overseeing clinical development strategies at AskBio for gene therapy projects. Leading cross-functional teams to ensure successful regulatory approval and commercial launches.

Posted 5/8/2026full-timeRemote • North Carolina • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Report to the head of Global Clinical Development
Be a core member of the GDNF Integrated Product Team (IPT)
Develop and implement the IPT’s clinical development strategy for clinical programs spanning all stages of product development
Work cross-functionally with groups including Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC
Establish and oversee global clinical development strategies in alignment with the company’s mission and values
Build and manage a team of medical directors and provide leadership as co-chair of the IPT’s Clinical Sub-team (CST)
Manage the creation and maintenance of critical study documents assigned to Clinical Development
Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile

Requirements

What you’ll need

MD, DO or equivalent (based on the current World Directory of Medical Schools), in addition to Neurology residency training
At least 10 years of clinical development experience in an industry environment spanning Phases I through III/IV
Strong track record and demonstrated excellence in IND/NDA/BLA submissions and approvals
Advanced clinical training, expertise and clinical research experience in a medical/scientific area, preferably with a neurology focus
In-depth knowledge of ICH-GCP, clinical trial design, biostatistics, and regulatory framework for global strategy development
Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders
Demonstrated strong leadership and effective communication skills with a documented record of delivering high quality projects/submissions in a global matrix environment in pharmaceutical or biotech industry or trial conduct in academia or clinical CRO is required
Firsthand experience in organizing and managing scientific or clinical advisory boards
Experience working with Patient Advocay Groups and other external stakeholders
Demonstrated experience with direct line management; overseeing team performance, fostering professional development, driving clinical development excellence within the organization.

Benefits

Comp & perks

Opportunity for secondment
Unique chance to broaden your experience
Contribute meaningfully to AskBio’s mission
Environment for employees to reach their fullest potential

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical developmentIND submissionsNDA submissionsBLA submissionsclinical trial designbiostatisticsregulatory frameworkneurology expertiseclinical research experiencedrug safety evaluation

Soft Skills

leadershipeffective communicationteam managementscientific partnershipstakeholder engagementproject deliveryprofessional developmentcross-functional collaborationorganizational skillsadvisory board management

Certifications

MDDO