Associate Medical Director, Safety Evaluation & Risk Management (Neuromuscular)

Opportunity for Secondment to AskBio

Were pleased to share an exciting secondment opportunity at 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 AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre interested in exploring this opportunity we encourage you to:

• Speak with your direct manager to discuss your interest and alignment with your development goals.

• Apply directly using the link provided in the posting.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples lives.

Our principles:

Position Summary

Under supervision of the VP Head of Medical Safety & Pharmacovigilance and as per company policies and procedures the Associate Medical Director Safety Evaluation & Risk Management (Neuromuscular) will be responsible for strategic and innovative medical leadership for Clinical Safety Pharmacovigilance and Risk Management activities for assigned AskBio investigational products. This individual will function in a matrix team environment interacting with several key internal stakeholder groups including Clinical Development Medical Affairs Regulatory Affairs Product Quality Compliance Quality Assurance Translational Medicine etc.

This role will be hybrid and can be located at any of our Companys headquarters.

Job Responsibilities

• Represent Medical Safety & Pharmacovigilance in Clinical Teams for assigned investigational products providing medical guidance in planning and gaining alignment for all safety matters and issues

• Lead Safety Management Team(s) navigating complex safety issues for assigned Investigational product(s) and responsible for all associated risk management activities including regular review of safety data for identification and evaluation of new safety signals

• Provide safety review and safety content for critical development program documents including protocols ICFs IBs IMPDs CSRs INDs CTAs and NDA/BLA/MAAs/IDMC Charters

• Provides/oversees medical review of adverse event reports to ensure the accuracy integrity and completeness of information entered in the safety database

• Provide input in responding to and resolving safety questions from regulatory authorities

• Provide input/oversee production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide

Minimum Requirements

• Advanced medical degree (e.g. MD MBBS DO) and 3 years of relevant experience in Safety Risk Management Clinical Safety or Pharmacovigilance

• Good working knowledge of global PV requirements (e.g. 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 consensus on safety topics

• Demonstrates excellent scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications

• Excellent written and spoken English

Preferred Education Experience and Skills

• Clinical research experience with exposure to clinical data collection assessment and analysis

• Gene therapy safety science experience

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 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 at or sending us an email at .