Sr. Medical Director/Medical Director, Global Safety Officer
Job Description
The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives.
Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively in a matrixed environment, and to be able to effectively communicate with varied stakeholders.
Responsibilities
Provide medical leadership within Drug Safety Benefit-Risk Management
Accountable for therapeutic area/product safety oversight and strategies/activities including (but not limited to):
Strategic advisement on clinical development plans and clinical protocols design
Responsible for developing safety content of IB and ICFs and support of DSMBs or study-specific safety review forums for clinical programs
Strategic safety input for regulatory documents, including benefit-risk content within the Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling etc.
Responsible for the content of any Risk Management Plan, and for the overall risk management and minimization strategies for assigned programs/portfolio, in alignment with internal stakeholders
Responsible for the content of aggregate safety reports (i.e., DSUR, PSUR, PADER) including assessment of benefit-risk evaluation
Advisement on the design of post-approval safety studies; Safety SME and contributor for publications, HEOR and epidemiology projects
Be a resource and the safety expert to DSPV, cross-functional teams and leadership, on matters of safety findings, quality issues, safety regulations and processes, industry standards, and other relevant topics relating to safety strategy and execution
Medical and Safety expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio
The Global Safety Officer (GSO) will lead safety oversight for assigned investigational and/or marketed products, including:
Lead product safety surveillance and signaling activities for assigned product(s) in collaboration with DSPV staff
Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
Ensure that routine signaling activities, assessment, and investigation are completed and documented in a timely manner
Ability to 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 any needed actions to update patient safety information
Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams
Qualifications
MD or MD/PhD required
Minimum of 4+ years of experience required for the Medical Director role, of 6+ years for the Sr. Medical Director role, in Drug Safety & Pharmacovigilance and/or other relevant clinical experience
Preferred Requirements:
Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology desirable
Safety/medical experience in the Neuroscience therapeutic space is highly desirable
Strategic and critical thinking skills
Leadership as well as the ability to perform effectively in a matrixed and dynamic environment, with the ability to collaborate across functions and geographies
Excellent communication (oral and written) as well as organizational skills.
Sense of urgency and accountability for both individual and team-owned work products
Knowledge of pre- and post-marketing US and EU regulations
In addition to the requirements above, the Sr. Medical Director level requires:
Demonstrated ability to lead safety strategy across global clinical programs and post-marketing settings
Experience representing DSPV in regulatory inspections and cross-functional governance forums
Advanced understanding of global pharmacovigilance regulations and benefit-risk frameworks
Experience contributing to scientific publications and external presentations on safety topics
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $285,000 to $320,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
#LI-MB1
About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives.
Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively in a matrixed environment, and to be able to effectively communicate with varied stakeholders.
Responsibilities
Provide medical leadership within Drug Safety Benefit-Risk Management
Accountable for therapeutic area/product safety oversight and strategies/activities including (but not limited to):
Strategic advisement on clinical development plans and clinical protocols design
Responsible for developing safety content of IB and ICFs and support of DSMBs or study-specific safety review forums for clinical programs
Strategic safety input for regulatory documents, including benefit-risk content within the Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling etc.
Responsible for the content of any Risk Management Plan, and for the overall risk management and minimization strategies for assigned programs/portfolio, in alignment with internal stakeholders
Responsible for the content of aggregate safety reports (i.e., DSUR, PSUR, PADER) including assessment of benefit-risk evaluation
Advisement on the design of post-approval safety studies; Safety SME and contributor for publications, HEOR and epidemiology projects
Be a resource and the safety expert to DSPV, cross-functional teams and leadership, on matters of safety findings, quality issues, safety regulations and processes, industry standards, and other relevant topics relating to safety strategy and execution
Medical and Safety expertise towards Business Development/Due Diligence activities for Alkermes Neuroscience portfolio
The Global Safety Officer (GSO) will lead safety oversight for assigned investigational and/or marketed products, including:
Lead product safety surveillance and signaling activities for assigned product(s) in collaboration with DSPV staff
Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
Ensure that routine signaling activities, assessment, and investigation are completed and documented in a timely manner
Ability to 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 any needed actions to update patient safety information
Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams
Qualifications
MD or MD/PhD required
Minimum of 4+ years of experience required for the Medical Director role, of 6+ years for the Sr. Medical Director role, in Drug Safety & Pharmacovigilance and/or other relevant clinical experience
Preferred Requirements:
Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology desirable
Safety/medical experience in the Neuroscience therapeutic space is highly desirable
Strategic and critical thinking skills
Leadership as well as the ability to perform effectively in a matrixed and dynamic environment, with the ability to collaborate across functions and geographies
Excellent communication (oral and written) as well as organizational skills.
Sense of urgency and accountability for both individual and team-owned work products
Knowledge of pre- and post-marketing US and EU regulations
In addition to the requirements above, the Sr. Medical Director level requires:
Demonstrated ability to lead safety strategy across global clinical programs and post-marketing settings
Experience representing DSPV in regulatory inspections and cross-functional governance forums
Advanced understanding of global pharmacovigilance regulations and benefit-risk frameworks
Experience contributing to scientific publications and external presentations on safety topics
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $285,000 to $320,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
#LI-MB1
About Us
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
About Alkermes, Inc.
At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. With our portfolio of marketed medicines and investigational pipeline candidates, we seek to make a meaningful difference in the way people manage their diseases. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.
Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.
Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
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