Alkermes
Executive Medical Director, DSPV – Alkermes
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Job Description The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for managing, mentoring and developing assigned benefit‑risk management staff and serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will provide safety leadership and advisement in company‑wide forums and initiatives.
Responsibilities
Provide medical leadership and management/development to direct reports within Drug Safety Benefit‑Risk Management
Accountable for therapeutic area/product safety oversight and strategies/activities performed by direct reports
Strategic advisement on clinical development plans and design of clinical protocols
Responsible for safety content of IB and ICFs and support of DSMBs
Analysis strategy for Integrated Summary of Safety (ISS) and benefit‑risk content within the Clinical Overview documents associated with regulatory filings
Responsible for the content of Risk Management Plan/REMS as required
Responsible for content of aggregate safety reports (e.g., DSUR, PSUR) including assessment of benefit‑risk
Advisement on the design of post‑approval safety studies
In role as a Global Safety Officer for assigned investigational and/or marketed products
Lead product safety surveillance and signaling activities in collaboration with DSPV staff
Acquire deep understanding of the disease process and assigned product(s) efficacy and safety profile, including working knowledge of other products in the class and therapeutic space
Ensure routine signaling activities and investigations are completed and documented timely
Effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities
Lead product benefit‑risk assessment and presentation to the Safety Committee and take needed actions to update patient safety information
Lead Drug Safety and Pharmacovigilance representation within the assigned program team, clinical development team and study management teams
Senior member of the Drug Safety leadership team
Advisement, employee development, design and implementation of department goals, policies and long‑term strategies
Senior medical leadership representative from Drug Safety with highly visible role in protocol review committees and other company‑wide forums and initiatives
Qualifications
MD, or MD PhD, or MD MPH required
Minimum of 10+ years of experience in drug safety
Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
High emotional intelligence with experience managing and developing direct reports as well as highly effective teams
Demonstrated strategic and critical thinking skills
Demonstrated leadership and ability to perform effectively in a matrixed and dynamic environment, collaborate across functions and geographies, and work in an entrepreneurial culture
Excellent communication (oral and written) and organizational skills
Demonstrated sense of urgency and accountability for both individual and team‑owned work products
Knowledge of pre‑ and post‑marketing US and EU regulations
Seniority Level Executive
Employment Type Full‑time
Job Function Health Care Provider
Benefits
Hybrid working environment: 60% office, 40% from home; requires onsite at Waltham, MA at least 3 days per week; not eligible for fully remote
Annual base salary $338,500 to $365,000; eligible for annual performance pay bonus; compensation may vary based on skills, training, knowledge and experience
Competitive benefits package; additional details at www.alkermes.com/careers#working-here
Referrals Referrals increase your chances of interviewing at Alkermes by 2x
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Job Description The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for managing, mentoring and developing assigned benefit‑risk management staff and serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will provide safety leadership and advisement in company‑wide forums and initiatives.
Responsibilities
Provide medical leadership and management/development to direct reports within Drug Safety Benefit‑Risk Management
Accountable for therapeutic area/product safety oversight and strategies/activities performed by direct reports
Strategic advisement on clinical development plans and design of clinical protocols
Responsible for safety content of IB and ICFs and support of DSMBs
Analysis strategy for Integrated Summary of Safety (ISS) and benefit‑risk content within the Clinical Overview documents associated with regulatory filings
Responsible for the content of Risk Management Plan/REMS as required
Responsible for content of aggregate safety reports (e.g., DSUR, PSUR) including assessment of benefit‑risk
Advisement on the design of post‑approval safety studies
In role as a Global Safety Officer for assigned investigational and/or marketed products
Lead product safety surveillance and signaling activities in collaboration with DSPV staff
Acquire deep understanding of the disease process and assigned product(s) efficacy and safety profile, including working knowledge of other products in the class and therapeutic space
Ensure routine signaling activities and investigations are completed and documented timely
Effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities
Lead product benefit‑risk assessment and presentation to the Safety Committee and take needed actions to update patient safety information
Lead Drug Safety and Pharmacovigilance representation within the assigned program team, clinical development team and study management teams
Senior member of the Drug Safety leadership team
Advisement, employee development, design and implementation of department goals, policies and long‑term strategies
Senior medical leadership representative from Drug Safety with highly visible role in protocol review committees and other company‑wide forums and initiatives
Qualifications
MD, or MD PhD, or MD MPH required
Minimum of 10+ years of experience in drug safety
Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
High emotional intelligence with experience managing and developing direct reports as well as highly effective teams
Demonstrated strategic and critical thinking skills
Demonstrated leadership and ability to perform effectively in a matrixed and dynamic environment, collaborate across functions and geographies, and work in an entrepreneurial culture
Excellent communication (oral and written) and organizational skills
Demonstrated sense of urgency and accountability for both individual and team‑owned work products
Knowledge of pre‑ and post‑marketing US and EU regulations
Seniority Level Executive
Employment Type Full‑time
Job Function Health Care Provider
Benefits
Hybrid working environment: 60% office, 40% from home; requires onsite at Waltham, MA at least 3 days per week; not eligible for fully remote
Annual base salary $338,500 to $365,000; eligible for annual performance pay bonus; compensation may vary based on skills, training, knowledge and experience
Competitive benefits package; additional details at www.alkermes.com/careers#working-here
Referrals Referrals increase your chances of interviewing at Alkermes by 2x
#J-18808-Ljbffr