Associate Supporting Safety Operations DSMB SDEA and Compliance

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

At AskBio weve 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 Parkinsons disease and congestive heart failure. Our gene therapy platform includes Pro10 an industryleading proprietary cell line manufacturing process and an extensive AAV capsid and promoter library.

We became a whollyowned 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 peoples 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 whats right in every situation. Make clear commitments and follow through.

Position Summary

Job Responsibilities

• Support across differed therapeutic areas Neuromuscular (Pompe LGMD); CNS (Parkinsons Multiple System Atrophy Huntington): Cardiovascular (CHF).
• Represent Medical Safety and Pharmacovigilance in Clinical Teams for assigned investigational products on Clinical safety operation aspects such as writing and managing Safety Management Plans (SMP) with CROs.
• Responsible for managing/coordinating weekly operational meetings with CROs and addressing issues to implement processes governed under SMP.
• Responsible for Managing the Safety Mailbox and ensuring cases are completed per the internal KPI (Key Process Indicator) and regulatory timelines.
• Engage in monitoring compliance with global pharmacovigilance requirements ensuring all processes and reports adhere to international standards.
• Monitor periodic reviews of SDEA and ensure requirements from SDEA are operationalized.
• Support and Monitor DSMB and other Safety Governance Process forums i.e. Charter Review & implementation supporting Presentations for the DSMB and other Safety Governance forums Scheduling and ensuring requirements from the protocol & SoPs for the DSMBs and other safety governance forums are operationalized.

Minimum Requirements

• Bachelors degree in Life science Nursing Pharmacy or related field with 5 years of relevant experience in Safety operations with exposure to Safety data collection tools SharePoint Power BI and Quality Management systems such as Veeva and ZenQMS is required. Or Masters Degree in Life science with 3 years of listed relevant experience is preferred.

• Knowledge of global pharmacovigilance reporting requirements per US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Strong interpersonal skills that facilitate collaboration across functions to reach a consensus on safety topics.
• Demonstrates excellent scientific/clinical and analytical knowledge base able to assess safety data and understand the safety/medical implications.
• Excellent written and spoken English.

Preferred Education Experience and Skills

• PharmD

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 jobrelated 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 ator sending us an email at .

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.