biomarin1mo ago

Senior Medical Director in Safety Science

United StatesRemotesenior

OtherMedical Director

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Quick Summary

Overview

Key Responsibilities

Medical Safety Leadership • Lead safety signal prediction, detection, evaluation, and risk management activities • Ensure medical expertise throughout the product lifecycle with adequate coverage of safety physicians for assigned products •…

Requirements Summary

Education and Experience • Hold an MD or equivalent medical qualification (active license to practice preferable but not required) • 8-10+ years of pharmaceutical industry PV experience • Experience with regulatory authority interactions •…

Technical Tools

data-analysis

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s 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.

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.

About Worldwide Research and Development

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.

ROLE 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. 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. The Executive Medical Director is responsible for building, attracting, developing, and retaining an efficient Safety Science team.

KEY RESPONSIBILITIES

Medical Safety Leadership

• Lead safety signal prediction, detection, evaluation, and risk management activities

• Ensure medical expertise throughout the product lifecycle with adequate coverage of safety physicians for assigned products

• Cultivate a proactive and predictive approach to theoretical and confirmed safety risks, while maintaining efficient pharmacovigilance monitoring and reporting practices

• Review and assess complex individual case safety reports (ICSRs), with particular focus on serious adverse events

• Provide medical interpretation of safety data and contribute to causality assessments

• Participate in safety governance committees and cross-functional team meetings

Strategic Safety Management

• Develop and implement proactive pharmacovigilance strategies for assigned products/therapeutic areas

• Design effective risk management plans and risk minimization measures

• Contribute to benefit-risk assessments and drive data-driven safety decisions

• Collaborate with clinical development teams on protocol safety design and safety monitoring plans

• Lead the development of safety sections for regulatory submissions

• Implement personal (and group) development plans to build scientific and clinical development experience

Regulatory Compliance and Communication

• Accountable for the delivery of high quality and timely Safety Science reports

• Author and review aggregate safety reports (PSURs/PBRERs, DSURs, RMPs)

• Represent the company in interactions with regulatory authorities on safety matters

• Contribute to safety-related product labeling and patient information

• Respond to health authority queries related to safety concerns

• Ensure compliance with evolving global pharmacovigilance regulations

Team Leadership and Development

• Provide medical guidance to Safety Science staff and cross-functional teams

• Mentor junior safety physicians and PV scientists

• Contribute to development of standard operating procedures and work instructions

• Lead continuous improvement initiatives within the PV department

• Collaborate effectively with global affiliates on safety-related activities

Scientific Advancement

• Maintain awareness of emerging safety methodologies and regulatory requirements

• Represent the company at scientific conferences and industry working groups

• Contribute to publications on product safety profiles and PV science

• Collaborate with epidemiology and real-world evidence teams on safety studies

• Drive innovation in safety signal detection and evaluation approaches

QUALIFICATIONS

Education and Experience

• Hold an MD or equivalent medical qualification (active license to practice preferable but not required)

• 8-10+ years of pharmaceutical industry PV experience

• Experience with regulatory authority interactions

• Leadership experience across different phases of clinical development

Technical Knowledge

• Expert knowledge of global PV regulations and anticipate regulatory trends

• Ability to apply advanced statistical methodologies for safety data analysis

• Familiarity with signal detection algorithms and quantitative PV methods

• Knowledge of benefit-risk assessment frameworks and methodologies, including how to evaluate risk minimization effectiveness

Desirable Advanced Skills

• Ability to interpret biomarker and genomic data related to safety

• Ability to integrate real-world data into safety assessments

• Ability to translate complex safety concepts for diverse stakeholders

• Ability to visualize complex safety data effectively

• Ability to interpret pharmacoepidemiology studies

Leadership Capabilities

• Ability to influence senior management on complex safety matters

• Balance safety considerations with medical need, strategic plans and regulatory expectations

• Strong leadership skills with managerial experience (direct and in a matrix environment)

• Develop safety strategies that balance innovation with compliance

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.

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.

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.

Equal Opportunity Employer/Veterans/Disabled

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.