VP, GDNF Clinical Development

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 :

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 be responsible for developing and implementing the IPT's clinical development strategy for clinical programs spanning all stages of product development.

As a core member of the GDNF IPT, the VP of GDNF Clinical Development will work cross-functionally with groups including Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC. They will be responsible for establishing and overseeing global clinical development strategies in alignment with the company's mission and values that will support regulatory approval and commercial launches in multiple territories including, but not limited to, the US, EU and UK. They will build and manage a team of medical directors and provide leadership as co-chair of the IPT's Clinical Sub-team (CST) in collaboration with a co-chair leading Clinical Operations. The CST is responsible for developing and driving the overall clinical strategy for the product to deliver the high-quality execution of complex clinical trials, and with strategic alignment of timelines in accordance with the overarching IPT clinical program strategy and objectives. The CST also provides oversight of clinical research activities, including development of core documents such as clinical development plans, investigator brochures, clinical trial protocols, statistical analysis plans, clinical study reports, and regulatory filings to meet program timelines.

The VP, GDNF Clinical Development will partner with AskBio's Safety and Pharmacovigilance teams to oversee medical monitoring and drug safety reporting. They will also work closely with Clinical Operations, Regulatory, Medical Affairs and Patient Advocacy teams on clinical study planning and resource management to execute global clinical studies. This individual will be responsible for the analysis, interpretation and reporting of clinical studies to support BLA / MAA filings and global product launch. As SME they will work closely with medical affairs, market access, and commercial product teams to maximize product positioning and value generation in preparation for commercial launches. Furthermore, the VP, GDNF Clinical Development will be positioned to expand and support the company's global relationships with clinical sites, investigators, patient and community organizations, internal functional teams, and third-party vendors.

Job Responsibilities

Minimum Requirements

Preferred Education, Experience and Skills

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.