b'nnnnnnnn Senior Medical Director in Safety Science | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn
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n BioMarin Pharmaceuticaln
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Senior Medical Director in Safety Science
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Location: United States
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Workstyle: Remote Only
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Apply
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Who We Are
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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
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About Worldwide Research and Development
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From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
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xc2xa0ROLE SUMMARY
The Senior/Executive Medical Director in Safety Science manages a group of medical safety experts providing strategic leadership across our product portfolio and ensuring that patient safety is a priority in pre- and post-marketing drug development activities.xc2xa0 This is an influential position responsible for driving innovative medical safety approaches, leading medical safety evaluations, managing safety-related regulatory interactions, and advancing the science of safety prediction and management using cutting-edge methodologies. This role combines clinical expertise, regulatory acumen, and strategic vision to ensure patient safety while enabling business objectives.xc2xa0 The Executive Medical Director is responsible for building, attracting, developing, and retaining an efficient Safety Science team.
KEY RESPONSIBILITIES
Medical Safety Leadership
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Lead safety signal prediction, detection, evaluation, and risk management activities
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ensure medical expertise throughout the product lifecycle with adequate coverage of safety physicians for assigned products
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Cultivate a proactive and predictive approach to theoretical and confirmed safety risks, while maintaining efficient pharmacovigilance monitoring and reporting practices
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Review and assess complex individual case safety reports (ICSRs), with particular focus on serious adverse events
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Provide medical interpretation of safety data and contribute to causality assessments
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Participate in safety governance committees and cross-functional team meetings
Strategic Safety Management
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Develop and implement proactive pharmacovigilance strategies for assigned products/therapeutic areas
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Design effective risk management plans and risk minimization measures
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Contribute to benefit-risk assessments and drive data-driven safety decisions
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Collaborate with clinical development teams on protocol safety design and safety monitoring plans
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Lead the development of safety sections for regulatory submissions
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Implement personal (and group) development plans to build scientific and clinical development experience
Regulatory Compliance and Communication
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Accountable for the delivery of high quality and timely Safety Science reports
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Author and review aggregate safety reports (PSURs/PBRERs, DSURs, RMPs)
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Represent the company in interactions with regulatory authorities on safety matters
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Contribute to safety-related product labeling and patient information
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Respond to health authority queries related to safety concerns
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ensure compliance with evolving global pharmacovigilance regulations
Team Leadership and Development
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Provide medical guidance to Safety Science staff and cross-functional teams
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Mentor junior safety physicians and PV scientists
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Contribute to development of standard operating procedures and work instructions
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Lead continuous improvement initiatives within the PV department
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Collaborate effectively with global affiliates on safety-related activities
Scientific Advancement
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Maintain awareness of emerging safety methodologies and regulatory requirements
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Represent the company at scientific conferences and industry working groups
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Contribute to publications on product safety profiles and PV science
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Collaborate with epidemiology and real-world evidence teams on safety studies
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Drive innovation in safety signal detection and evaluation approaches
QUALIFICATIONS
Education and Experience
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Hold an MD or equivalent medical qualification (active license to practice preferable but not required)
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 8-10+ years of pharmaceutical industry PV experience
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Experience with regulatory authority interactions
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Leadership experience across different phases of clinical development
Technical Knowledge
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Expert knowledge of global PV regulations and anticipate regulatory trends
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to apply advanced statistical methodologies for safety data analysis
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Familiarity with signal detection algorithms and quantitative PV methods
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Knowledge of benefit-risk assessment frameworks and methodologies, including how to evaluate risk minimization effectiveness
Desirable Advanced Skills
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to interpret biomarker and genomic data related to safety
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to integrate real-world data into safety assessments
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to translate complex safety concepts for diverse stakeholders
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to visualize complex safety data effectively
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to interpret pharmacoepidemiology studies
Leadership Capabilities
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ability to influence senior management on complex safety matters
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Balance safety considerations with medical need, strategic plans and regulatory expectations
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Strong leadership skills with managerial experience (direct and in a matrix environment)
xe2x80xa2xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Develop safety strategies that balance innovation with compliance
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Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as required or assigned.
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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Equal Opportunity Employer/Veterans/Disabled
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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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The salary range for this position is: $278,500 to $382,910. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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Recruitment Fraud Alert Notice
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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.
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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.
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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you
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Equal Opportunity Employer/Veterans/Disabled
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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.
nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.
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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.
nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.
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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.
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