Sr. Medical Director, Safety Evaluation & Risk Management
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Job Description
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
Under supervision of the VP, Head of Medical Safety & Pharmacovigilance, and as per company policies and procedures, the Senior Medical Director, Safety Evaluation & Risk Management 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 position will be hybrid located in our Raleigh, NC or Philadelphia, PA 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, CSRs, INDs, CTAs, and NDA/BLA/MAAs/IDMC Charters
Oversee 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
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
MD, DO or equivalent with relevant post-graduate clinical training
Minimum of 12 years of relevant work experience, including 5+ years of experience working in clinical safety and 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
Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
Excellent written and spoken English
Knowledge of medical and therapeutic terminology
Ability to review emerging data and proactively ensure the delivery of high-quality study results
Preferred Education, Experience and Skills
Gene therapy safety science experience
Deep understanding of the drug development process (preferred in CNS therapeutic areas)
Experience with NDA and IND submissions
Excellent writing skills and ability to convey moderately complex technical information clearly to others
Proficient in meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results
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 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 talent@askbio.com.