Medical Director, Global Drug 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 a Medical Director, Global Drug Safety. This role will work on assigned studies and/or programs therefore responsible for many aspects of safety activities including safety medical review, data analysis and interpretation, preparation of periodic regulatory safety submissions and study reports. He/she will also contribute to Inspection Readiness and continuous PV process improvement. The successful candidate will have experience in medical and scientific safety assessment in clinical development and preferably also working knowledge of 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. This individual must be able to work in a spirit of collaboration and service, while also operating with an appropriate level of independent judgment. Denali is seeking candidates with a can-do attitude who work with the highest integrity, fostering an environment of compliance and continuous improvement.

Responsibilities

• Under supervision of the Executive Director, Safety Science and as per company policies and procedures, for assigned Denali programs, responsible for safety deliverables for assigned programs or studies.

• Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database.

• Provide safety content for study-level documents including protocols, ICFs, CSR, and when required, to IBs, INDs, CTAs, and NDA/BLA/MAAs

• Coordinating the program level Safety Management Team (SMT) to review safety signal evaluation reports and recommendations for risk characterization.

• Responsible for the completion of safety regulatory submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide

• Track implementation of SMT and DSC decisions.

• May support responses to questions from regulatory authorities.

• Support regulatory agency audits and inspections, and corrective action plans.

• Support PV vendor oversight in collaboration with Safety Operations

• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications:

• Advanced medical degree (e.g., MD, MBBS, DO) required

• 3+ years of experience in the drug safety and pharmacovigilance with a track record of successful deliveries of core safety/PV activities in cross-functional safety teams.

• 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.

• Willingness to teach and to learn.

Salary Range: $265,000.00 - $291,333.00. 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.

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