Denali Therapeutics
Medical Director, Safety Sciences
Provides senior clinical leadership for safety strategy and oversight across multiple development programs or a therapeutic area. Leads complex safety assessments, drives cross-functional safety decision-making, and contributes to portfolio-level benefit–risk evaluation.
Key Responsibilities
- • Provides strategic safety leadership across multiple programs or therapeutic area.
- • Leads safety signal detection (including complex cases), evaluation, and risk assessment and management activities across development programs.
- • Owns and drives benefit–risk assessments for assigned products and informs program and portfolio decisions.
- • Oversees preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- • Provides medical review and causality assessment of individual case safety reports
- • Provides senior medical safety leadership in safety governance forums, including Safety Review Committees and Data Monitoring Committees.
- • Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies for clinical programs.
- • Leads development and implementation of risk management strategies, including Risk Management Plans (RMPs) and REMS where applicable.
- • Represents Drug Safety in cross-functional program teams and governance discussions.
- • Mentors and develops Medical Directors and other safety scientists within the function.
- • Contributes to safety process improvements, standards, and best practices across the organization.
- • Participates in regulatory inspections and internal audits.
Required
- • MD or MD/PhD required.
- • 10+ years of relevant experience in drug safety, pharmacovigilance, or clinical development with progression to program or multi-program safety leadership.
- • Deep understanding of global pharmacovigilance regulations, signal detection methodologies, and safety risk management.
- • Demonstrated ability to influence cross-functional decisions and lead complex safety discussions.
- • Recognized clinical and scientific credibility.
Benefits & Perks
- • 401k
- • healthcare coverage
- • ESPP
- • broad range of other benefits
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This job provides senior clinical leadership for safety strategy and oversight across multiple development programs or a therapeutic area. Leads complex safety assessments, drives cross-functional safety decision-making, and contributes to portfolio-level benefit–risk evaluation.
Key Accountabilities / Core Job Responsibilities
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This job provides senior clinical leadership for safety strategy and oversight across multiple development programs or a therapeutic area. Leads complex safety assessments, drives cross-functional safety decision-making, and contributes to portfolio-level benefit–risk evaluation.
Key Accountabilities / Core Job Responsibilities
- Provides strategic safety leadership across multiple programs or therapeutic area.
- Leads safety signal detection (including complex cases), evaluation, and risk assessment and management activities across development programs.
- Owns and drives benefit–risk assessments for assigned products and informs program and portfolio decisions.
- Oversees preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- Provides medical review and causality assessment of individual case safety reports
- Provides senior medical safety leadership in safety governance forums, including Safety Review Committees and Data Monitoring Committees.
- Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies for clinical programs.
- Leads development and implementation of risk management strategies, including Risk Management Plans (RMPs) and REMS where applicable.
- Represents Drug Safety in cross-functional program teams and governance discussions.
- Mentors and develops Medical Directors and other safety scientists within the function.
- Contributes to safety process improvements, standards, and best practices across the organization.
- Participates in regulatory inspections and internal audits.
- MD or MD/PhD required.
- 10+ years of relevant experience in drug safety, pharmacovigilance, or clinical development with progression to program or multi-program safety leadership.
- Deep understanding of global pharmacovigilance regulations, signal detection methodologies, and safety risk management.
- Demonstrated ability to influence cross-functional decisions and lead complex safety discussions.
- Recognized clinical and scientific credibility.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
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