Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Accountabilities/Core Job Responsibilities:
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Responsible for the strategic planning, implementation, and management of Denali Safety Operations and PV compliance activities to ensure compliance with all applicable laws and regulations reporting to the VP and Head of Drug Safety.
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Serve as an expert on global PV regulations. Lead and support Product Launch Roadmap initiatives related to pharmacovigilance. Responsible for vendor/systems oversight both at the strategic level and at the implementation level. Responsible for the development and adherence of internal and external (with vendors) key performance indicators and metrics to track PV performance. Ensure workflows between CROs, Denali and any business partners are clear, well-delineated and adequately followed.
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Responsible for the global PV system. Evolve the safety quality management system (QMS). Guide the safety team to prepare for internal audits and global inspections and address corrective action plans arising from audits and inspections.
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Collaborate with Clinical Quality and Product Quality (CMC Quality) to ensure awareness and training of appropriate company personnel to Safety specific policies and SOPs as appropriate. Responsible for proactively identifying and developing required procedural documents.
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Ensure close collaboration with safety science. Provide operational support for Safety Management Team, signal detection and risk management activities as well as NDA/BLA filings.
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Ensure collaboration and communication with functions involved with receiving, investigating, or reporting AEs including collaboration with commercial, medical affairs, CMC and product quality organizations to fulfill postmarking PV reporting requirements.
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Responsible for the development and maintenance of partnership agreements with business partners to ensure seamless co-development and co-commercialization.
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May function as a safety operations representative at Study Executive Teams (SETs) when appropriate.
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Actively contribute to key department goals and objectives, drive process and operational efficiencies. Participates in the development and management of departmental budget.
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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/Skills:
Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience highly desirable. Bachelor’s degree in health care or life sciences at minimum.
12+ years of experience in pharmaceutical safety and 5+ years of functional management experience overseeing PV staff and/or consultants/CRO
Expert knowledge of global PV requirements. Strong experience with NDA/BLA global submissions and post-approval PV support. Extensive experience participating in inspections/audits and CAPAs management
Highly self-motivated. Ability to thrive in a fast-paced dynamic environment. Strong commitment to excellence and continuous process improvement.
Strong organizational skills including effective communication, time management, attention to detail and prioritization.
Salary Range: 255,000.00 to 287,000.00 . 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.
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