GQR
Sr. Medical Director/Medical Director, Global Safety Officer
Our client, a fully-integrated global biopharmaceutical company headquartered in Ireland with significant U.S. operations, is seeking a Sr. Medical Director/Medical Director, Global Safety Officer (GSO) to provide strategic safety oversight for their Neuroscience portfolio. This is a visible leadership role reporting to the Head of Drug Safety and Pharmacovigilance (DSPV), providing safety advisement across company-wide forums and initiatives.
Please note: This position is with one of our client companies and is NOT a role at GQR.
What You’ll Do
Provide medical leadership within Drug Safety Benefit-Risk Management, serving as the safety expert on matters of safety findings, quality issues, regulations, and industry standards
Lead therapeutic area/product safety oversight including strategic advisement on clinical development plans, protocol design, and safety content for regulatory documents
Develop Risk Management Plans and oversee risk management/minimization strategies for assigned programs in alignment with stakeholders
Lead creation of aggregate safety reports (DSUR, PSUR, PADER) with comprehensive benefit-risk evaluations
Lead product safety surveillance and signaling activities, ensuring routine assessments and investigations are completed timely
Acquire deep understanding of disease processes and product efficacy/safety profiles, including competitive landscape knowledge
Lead product benefit-risk assessments and presentations to the Safety Committee
Serve as Drug Safety and Pharmacovigilance representative across program teams, clinical development teams, and study management teams
Provide safety expertise for Business Development/Due Diligence activities
What You Bring
MD or MD/PhD required
4+ years of Drug Safety & Pharmacovigilance experience for Medical Director role; 7+ years for Sr. Medical Director role
Strategic and critical thinking skills with demonstrated leadership ability in matrixed environments
Excellent communication (oral and written) and organizational skills
Sense of urgency and accountability for individual and team work products
Knowledge of pre- and post-marketing US and EU regulations
Preferred
Prior experience in patient care, clinical development, and/or clinical pharmacology
Safety/medical experience in the Neuroscience therapeutic space
For Sr. level: Ability to lead safety strategy across global programs, represent DSPV in regulatory inspections, advanced understanding of global pharmacovigilance regulations, and experience with scientific publications
This hybrid role requires 3 days per week onsite at the client’s Waltham, MA office (60% onsite / 40% remote). Not eligible for fully remote work.
Our client is a certified Great Place to Work with a strong commitment to diversity, inclusion, and employee wellbeing.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Student loan assistance
Disability insurance
Tuition assistance
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Please note: This position is with one of our client companies and is NOT a role at GQR.
What You’ll Do
Provide medical leadership within Drug Safety Benefit-Risk Management, serving as the safety expert on matters of safety findings, quality issues, regulations, and industry standards
Lead therapeutic area/product safety oversight including strategic advisement on clinical development plans, protocol design, and safety content for regulatory documents
Develop Risk Management Plans and oversee risk management/minimization strategies for assigned programs in alignment with stakeholders
Lead creation of aggregate safety reports (DSUR, PSUR, PADER) with comprehensive benefit-risk evaluations
Lead product safety surveillance and signaling activities, ensuring routine assessments and investigations are completed timely
Acquire deep understanding of disease processes and product efficacy/safety profiles, including competitive landscape knowledge
Lead product benefit-risk assessments and presentations to the Safety Committee
Serve as Drug Safety and Pharmacovigilance representative across program teams, clinical development teams, and study management teams
Provide safety expertise for Business Development/Due Diligence activities
What You Bring
MD or MD/PhD required
4+ years of Drug Safety & Pharmacovigilance experience for Medical Director role; 7+ years for Sr. Medical Director role
Strategic and critical thinking skills with demonstrated leadership ability in matrixed environments
Excellent communication (oral and written) and organizational skills
Sense of urgency and accountability for individual and team work products
Knowledge of pre- and post-marketing US and EU regulations
Preferred
Prior experience in patient care, clinical development, and/or clinical pharmacology
Safety/medical experience in the Neuroscience therapeutic space
For Sr. level: Ability to lead safety strategy across global programs, represent DSPV in regulatory inspections, advanced understanding of global pharmacovigilance regulations, and experience with scientific publications
This hybrid role requires 3 days per week onsite at the client’s Waltham, MA office (60% onsite / 40% remote). Not eligible for fully remote work.
Our client is a certified Great Place to Work with a strong commitment to diversity, inclusion, and employee wellbeing.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Student loan assistance
Disability insurance
Tuition assistance
#J-18808-Ljbffr