VP, GDNF Clinical Development

AskBio Inc.; Durham (NC); On-site; USD 200,000 - 250,000; Full time

Job summary

AskBio Inc. is seeking a Vice President (VP) of GDNF Clinical Development in Durham, North Carolina. This role encompasses leading global clinical strategies, managing clinical development initiatives across diverse teams, and ensuring high-quality execution of clinical trials. The ideal candidate must possess an MD or DO with neurology residency training plus at least 10 years of clinical development experience, particularly in IND/NDA/BLA submissions. Join AskBio to innovate in gene therapy solutions that transform lives.

Qualifications

• At least 10 years of clinical development experience in an industry environment.
• Demonstrated excellence in IND/NDA/BLA submissions and approvals.
• In-depth knowledge of ICH-GCP and regulatory frameworks.

Responsibilities

• Lead global strategic clinical development initiatives for GDNF IPT.
• Manage and mentor a team of clinical development physicians.
• Partner with cross-functional teams for clinical trial design and execution.

Skills

Clinical development experience

Leadership skills

Communication skills

Scientific partnership

Neurology expertise

Education

MD or DO

Neurology residency training

Job description

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.

Position Summary

The Vice President (VP), GDNF Clinical Development, will report to the head of Global Clinical Development. Operationally the VP, GDNF Clinical Development will be a core member of the GDNF Integrated Product Team (IPT) and will be responsible for developing and implementing the IPT’s clinical development strategy for clinical programs spanning all stages of product development. The VP will work cross‑functionally with Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Non‑clinical, Drug Delivery and CMC. They will establish and oversee global clinical development strategies in alignment with the company’s mission and values that support regulatory approval and commercial launches in multiple territories, including the US, EU and UK. The VP will build and manage a team of medical directors and provide leadership as co‑chair of the IPT’s Clinical Sub‑team (CST). The CST is responsible for developing and driving the overall clinical strategy and ensuring high‑quality execution of complex clinical trials. The VP will partner with AskBio’s Safety and Pharmacovigilance teams, oversee medical monitoring and drug safety reporting, and work closely with Clinical Operations, Regulatory, Medical Affairs and Patient Advocacy teams on clinical study planning and resource management. The VP, GDNF Clinical Development, will be responsible for the analysis, interpretation and reporting of clinical studies to support BLA/MAA filings and global product launch and will engage with medical affairs, market access and commercial product teams to maximize product positioning and value generation.

Job Responsibilities

• Lead the global strategic clinical development initiatives for AskBio’s GDNF IPT, fostering cross‑functional alignment via open and collaborative discussions.
• Lead, manage, and mentor a team of clinical development physicians.
• Contribute to budget planning and budget management related to clinical development activities aligned with the IPT goals.
• Provide clinical development input and maintain alignment with the CNS Drug Delivery IPT and GDNF IPT development plans.
• Contribute to development and execution of the clinical strategy across GDNF and other CNS programs, ensuring scientific rigor, cost‑effectiveness, and success.
• Proactively identify clinical risks and implement risk mitigation strategies for complex gene therapy studies.
• Provide input to CDP development in line with the Target Product Profile (TPP) for successful global regulatory approvals and market access.
• Partner cross‑functional colleagues (Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Non‑clinical, Drug Delivery and CMC) to design, execute and report clinical trials.
• Partner with Clinical Operations to co‑chair the IPT CST to oversee, execute and deliver the end‑to‑end clinical development strategy in alignment with the overall product strategy and objectives.
• Provide clinical development input as a member of the IPT Brand Subteam.
• Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Study Protocols, Investigator’s Brochures, Informed Consent Forms, Risk‑Based Medical Monitoring Plan, Clinical Study Reports and other key regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs.
• Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post‑marketing surveillance. May serve as a core member of the Safety Management Team.
• Lead the GDNF Clinical Development team during interactions regarding drug development, safety, marketing, regulatory filing, and other aspects of a CNS gene therapy product life cycle.
• As the neurology medical expert, participate in interactions with external stakeholders (e.g., regulatory authorities, KOLs, Data Monitoring Committee, advisory boards, patient advocacy groups).
• Work collaboratively with Medical Affairs to prepare and present abstracts, manuscripts and presentations for external meetings and publications.
• May support technical due diligence in Business Development & Licensing activities.

Minimum Requirements

• MD, DO or equivalent, plus neurology residency training.
• At least 10 years of clinical development experience in an industry environment spanning Phase I through Phase 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 the pharmaceutical or biotechnology industry or trial conduct in academia or clinical CRO.
• Firsthand experience in organizing and managing scientific or clinical advisory boards.
• Experience working with patient advocacy groups and other external stakeholders.
• Demonstrated experience with direct line management; overseeing team performance, fostering professional development, and driving clinical development excellence within the organization.

Preferred Education, Experience and Skills

• Advanced knowledge in gene therapy drug development, training or experience in neurosciences with the capability to innovate in clinical development study designs that provide robust clinical evidence to internal decision‑makers and regulatory agencies.
• Movement disorders fellowship training with clinical research experience.
• Experience with radiographic evaluation of neurologic disease and biomarker development.

Equal Opportunity Statement

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.