VP, GDNF Clinical Development

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

55d

About The Position

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: 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 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.

Requirements

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

Nice To Haves

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

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 that the overall scientific and medical content of each clinical study is scientifically rigorous, cost-effective sound and designed for success
Proactively work to 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 (including Clinical Operations, Medical Affairs, Pharmacovigiliance, Regulatory, Commercial, Nonclinical, 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 alignement 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 (CSPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), 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 (SMT)
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 (DMC), 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 (BD&L) activities