Medical Director, Safety Sciences

Denali Therapeutics; South San Francisco (CA); Presencial; USD 272 000 - 336 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401k

Healthcare coverage

ESPP

Resumo da oferta

Denali Therapeutics is seeking a senior safety leader to guide medical safety strategy across multiple development programs. You will drive signal detection, risk assessment, and cross-functional decision-making to optimize benefit–risk profiles.

With 10+ years in pharmacovigilance or clinical development, you will oversee regulatory safety submissions, mentor safety staff, and shape global safety monitoring strategies, contributing to audits and inspections.

Qualificações

• MD or MD/PhD with senior safety leadership experience.
• 10+ years in drug safety/pharmacovigilance or clinical development.
• Deep knowledge of global pharmacovigilance regulations and risk management.

Responsabilidades

• Provide strategic safety leadership across multiple programs or therapeutic areas.
• Lead safety signal detection, evaluation and risk assessment across development programs.
• Own benefit–risk assessments and inform portfolio decisions.
• Oversee aggregate safety reports, regulatory safety submissions, and safety sections of filings.
• Provide medical review and causality assessment of individual case safety reports.
• Lead safety governance forums including Safety Review Committees and DMCs.
• Partner with Clinical Development, Regulatory Affairs and Biostatistics to shape safety monitoring strategies.
• Develop and implement risk management plans (RMPs) and REMS where applicable.
• Represent Drug Safety in cross-functional program teams and governance discussions.
• Mentor and develop Medical Directors and safety scientists.
• Contribute to safety process improvements and best practices.
• Participate in regulatory inspections and internal audits.

Conhecimentos

Drug safety leadership

Pharmacovigilance

Global regulatory knowledge

Cross-functional influence

Clinical credibility

Formação académica

MD or MD/PhD

Descrição da oferta de emprego

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

• 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.

Qualifications/Skills

• 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.

Salary Range: $272,000.00 to $336,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

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.