Sr. Medical Director, Clinical Development (CNS/GDNF)

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, Germany, and Spain.

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 Senior Medical Director, Clinical Development (CNS/GDNF), reporting to the Vice President, GDNF Clinical Development, will be the global clinical leader responsible for one or more clinical studies across indications, involving one or multiple investigational products. Serving as a core member of the study teams, this role is responsible for unblinded medical monitoring of the safety signal associated with the study procedurals and the investigational products, working closely with the study sites/ Investigators, pharmacovigilance, blinded medical monitors at Askbio, delivery team, and the medical team at CROs, leading DSMB workstream and be responsible for patient’s safety. This position will be accountable for the study design, medical oversight of clinical trial execution, and reporting of a clinical development program(s) to support internal governance decisions and global regulatory submissions.

This position will be located in RTP, NC or Philadelphia, PA.

Job Responsibilities

• Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other study/program documents (specifically overall safety insights pertaining to the unblinded study data)
• Participates in cross-functional teams (blinded and un-blinded teams), along with Clinical Operations, to ensure seamless transition of study participants from neurology to neurosurgery sites, provides oversight of study safety, subjects follow -up, and overall timelines for key deliverables
• Monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the product and intervention (specifically overall safety insights pertaining to the unblinded study data)
• Responsible for the proactive monitoring of clinical trial safety which is conducted in collaboration with the Safety team. Evaluates all safety data generated in clinical trials and responds to (unblinded) safety questions from investigator sites and IRBs regarding safety issues and queries. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations
• Generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy
  
  

Minimum Requirements

• Advanced medical degree or MD equivellent (e.g., MD, MBBS, DO) and 12 years’ relevant industry experience
• Strong clinical research background, particularly in CNS indications
• A minimum of 3 years of director level in clinical development or phase 2-3 clinical trial experience
• Must possess excellent oral and written English communication skills
  
  

Preferred Education, Experience And Skills

• Prefer experience in gene and cell therapy
• Prefer experience in rare diseases
• Prefer experience with neuroimaging and intracranial procedurals
• Prefer regulatory submission experience (BLA, NDA etc.)
• Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials
• Strong cross matrix team leadership skills, ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds
• Advanced analytical skills, strategic thinking and study activity planning
• Experience with reviewing neuroimaging, comfortable with neurocritical care, familiar with intracranial intervention
• Be responsive and engage in a remote working environment, strong working ethics
  
  

Asklepios BioPharmaceutical, 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.