VP, GDNF Clinical Development

AskBio Inc.; United States; On-site; USD 200,000 - 300,000; Full time

Job summary

AskBio Inc. is seeking a Vice President (VP) for GDNF Clinical Development to oversee global clinical strategies across stages. This leadership role involves collaboration with various departments and mentoring clinical development physicians to ensure successful drug applications.

Ideal candidates will possess an MD or DO with Neurology residency, substantial clinical development experience, and strong leadership skills. Join us at AskBio to advance gene therapy, impacting lives worldwide.

Qualifications

• At least 10 years of clinical development experience spanning Phases I through III/IV.
• Strong track record in IND/NDA/BLA submissions and approvals.
• Advanced knowledge in gene therapy drug development.

Responsibilities

• Lead global strategic clinical development initiatives for AskBio's GDNF IPT.
• Manage and mentor a team of clinical development physicians.
• Provide clinical development input for successful regulatory approvals.

Skills

Clinical development experience

Leadership skills

Communication skills

Expertise in Neurology

Knowledge of ICH-GCP

Experience with Patient Advocacy Groups

Education

MD or DO with Neurology residency

Job description

Opportunity for Secondment to AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission to advance gene therapy and change the lives of patients around the world.

Position Summary

The Vice President (VP), GDNF Clinical Development, will report to the head of Global Clinical Development. The VP 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 all stages of product development. The VP will work cross-functionally with Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery, and CMC to establish and oversee global clinical development strategies aligned with the company’s mission and values, supporting regulatory approval and commercial launches in the US, EU, UK, and other territories. The VP will build and manage a team of medical directors, serve as co-chair of the IPT’s Clinical Sub-team (CST) with a co-chair leading Clinical Operations, and oversee the creation and maintenance of critical study documents.

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 of each clinical study
• Proactively identify clinical risks and implement 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 with cross-functional colleagues—Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Nonclinical, Drug Delivery, and CMC—to design, execute, and report clinical trials
• Co-chair the IPT CST with Clinical Operations to oversee, execute, and deliver the end-to-end clinical development strategy in alignment with 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 (e.g., Clinical Study Protocols, Investigator’s Brochures, Informed Consent Forms, Risk-Based Medical Monitoring Plans, 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 continuously evaluate the drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance
• Serve as a core member of the Safety Management Team (SMT) as needed
• Lead the GDNF Clinical Development team during interactions concerning drug development, safety, marketing, regulatory filing, and other aspects of a CNS gene therapy product life cycle
• Act as the neurology medical expert in interactions with external stakeholders (e.g., regulatory authorities, KOLs, Data Monitoring Committee, advisory boards, patient advocacy groups)
• Collaborate with Medical Affairs to prepare and present abstracts, manuscripts, and presentations for external meetings and publications
• Support technical due diligence in Business Development & Licensing activities as necessary

Minimum Requirements

• MD, DO or equivalent (based on the World Directory of Medical Schools) with 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 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 partnerships 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 biotech industry, or in academic or CRO clinical conduct
• 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
• Advanced knowledge in gene therapy drug development, training or experience in neurosciences, and 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

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 have a disability or are a disabled veteran and require reasonable accommodation to use this website, please call [phone] or email [e-mail].