Career Opportunities in the Foresite Capital Network

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

The Denali Regulatory Project Manager (RPM) Associate Director, reporting to the head of Regulatory Operations and Medical Writing, is a highly motivated and creative individual with deep and broad regulatory project management experience. This individual will be accountable for regulatory project management of all of Denali’s drug candidates from IND/CTA through BLA/NDA/MAA; and working closely with Regulatory Program managers, Medical Writing, Regulatory Operations, and the subject matter experts (SMEs) within the Development Organization to help ensure the teams are delivering on their program goals.

Denali Regulatory Affairs is dedicated to developing innovative regulatory strategies to facilitate development and approval of novel therapies in neurodegenerative diseases. Denali is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making.

Responsibilities

• Develops and manages timelines for program regulatory activities including regulatory documents (eg, protocols, investigator’s brochures, clinical study reports, briefing packages), health authority interactions, and submissions (eg, INDs, CTAs, BLAs/NDAs, MAAs).
• Liaises with Regulatory Program Managers and Program Directors to ensure that regulatory activity timelines are aligned with overall program and corporate goals and adjusted as necessary to account for changing priorities.
• Partners with SMEs to ensure timely completion of deliverables.
• Runs efficient and effective cross-functional health authority interaction and filing team meetings, tracking the status of all deliverables, decisions, and action items; identifying risks to timelines and mitigations to address those risks; and characterizing the impact of delays to timelines and working in partnership with the Filing Team/Health Authority Interaction Lead with the vested functions to update timelines as necessary.
• Maintains regulatory document development timeline templates and models for projected resources to support regulatory activities and program needs; supports development of Regulatory Affairs long-range and yearly budget forecasts.
• Coordinates regulatory team meetings and provides support to initiatives and special projects (eg, selection and implementation of a regulatory information management system). as needed.

Minimum Qualifications

• A bachelor’s degree in science/technology or an equivalent combination of education and experience.
• A minimum of 8 years or equivalent relevant experience in project management.
• Regulatory project management experience on INDs/CTAs and marketing applications; experience in rare disease and/or complex filings a plus.
• Proficient at Smartsheet and/or other project and resource management software.
• Exceptional organizational skills with a high level of attention to detail.
• Excellent written and verbal communication skills.
• Strong influencing, partnership, and collaboration skills.
• Well-prepared, competent, and confident when interacting with senior management and internal and external partners.
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues and mitigate risks.

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: $165,000 to $205,000. 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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