Executive Director, Global Medical Safety

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

The Opportunity

In anticipation of the Company’s growth plans, Denali Therapeutics is looking for an Executive Director, Global Medical Safety. This role will be responsible for directing and implementing all aspects of safety strategy for assigned Denali programs. The successful candidate will be experienced in the medical and scientific safety assessment in all phases of clinical development as well as in successful NDA/BLA submissions and continued post-approval safety surveillance. He/she will be a proven collaborator and self-starter who has the ability to thrive in a matrixed environment; and has leadership experience in leading safety aspects of clinical development for multiple programs.

Responsibilities

• Responsible for responding to and resolving safety questions from regulatory authorities.
• Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
• Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations
• Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
• Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
• Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
• Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
• Support regulatory agency audits and inspections, and corrective action plans
• Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide

Minimum Qualifications

• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
• 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post- marketing environments.
• Advanced medical degree (e.g., MD, MBBS, DO) required
• Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications

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.

Salary Range: $296,667 to $345,000. 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.

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