Vice President, Early Clinical Oncology at Denali Therapeutics
SSF, California, USA -
Full Time


Start Date

Immediate

Expiry Date

16 Nov, 25

Salary

441324.0

Posted On

16 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Therapeutic Areas, Clinical Development, Unity, Translational Science, Leadership Skills, Oncology, Ae, Strategy, Drug Development, Oversight, Ind, Reporting, Regulatory Agencies, Clinical Trials, Espp

Industry

Pharmaceuticals

Description

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.
The Opportunity
Metastatic and primary brain tumors remain one of the greatest unmet needs in oncology. At Denali Therapeutics, we are committed to developing breakthrough therapies by combining deep expertise in disease biology with our proprietary TransportVehicle™ platform for targeted delivery to the brain and body.
We are seeking a Vice President, Early Clinical Oncology to provide strategic and clinical leadership in Oncology, working closely with Discovery to shape our pipeline. The ideal candidate will bring extensive, up-to-date experience in solid tumor development, including designing and executing Phase 1 and 2 trials within competitive, combination-therapy landscapes.
Reporting to the Chief Medical Officer, the Vice President, Early Clinical Oncology will play a key role in defining clinical strategy, leading cross-functional teams, and engaging with investigators, regulators, and external experts to advance Denali’s oncology programs.
This is a unique opportunity for a physician–scientist oncologist passionate about translating innovative science into transformative therapies for cancer patients.

QUALIFICATIONS

  • MD or MD-PhD with formal training in oncology.
  • 15+ years of industry, clinical development, or related academic experience in oncology, including 6+ years leading cross-functional development teams and/or managing people.
  • Proven track record in championing and leading success in the development of new therapeutic targets or therapeutic areas
  • Demonstrated cross-functional leadership skills, with experience building and developing high-performing clinical teams.
  • Excellent written, verbal, and presentation skills, with the ability to communicate complex concepts clearly.
  • Effective collaborator with the ability to influence strategy across multidisciplinary teams.
  • Strong understanding of translational science and its application in oncology drug development.
  • Experience in IND/CTA submissions and engagement with regulatory authorities in meetings and written responses throughout clinical development.
  • Expertise in medical surveillance, including oversight of Adverse Event (AE) and Serious Adverse Event (SAE) reporting and follow-up.
  • Experience designing and leading Phase I-III oncology clinical trials, including first-in-human (FIH) and dose escalation studies, preferably in solid tumors.
  • Demonstrated success with regulatory agencies at end-of-Phase 2, NDA/BLA submissions, and achievement of drug approval milestones
  • Position is based in South San Francisco, CA, with up to 25% travel expected in the future.
    Salary Range: $377,775.00 to $441,324.00 . 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.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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Responsibilities
  • Provide clinical leadership for oncology programs, from leading Clinical Development Plan (CDP) design, study design and execution.
  • Work closely with the CMO to establish a data-driven oncology strategy targeting key gaps in patient care
  • Drive integrated, data-driven strategies in partnership with discovery, translational, regulatory, statistical, clinical pharmacology, and safety teams.
  • Hands on oversight of clinical science aspects of trial design, conduct, data interpretation, and reporting, ensuring focus on safety, pharmacodynamics, and efficacy.
  • Lead preparation of clinical and regulatory documents, including protocols, investigator brochures, study reports, and submissions.
  • Conduct and supervise medical monitoring and safety reporting throughout trials.
  • Partner with Discovery to evaluate and prioritize preclinical oncology targets, providing clinical feasibility insights.
  • Mentor and manage clinical science team members.
  • Collaborate with academic experts to advance oncology innovation.
  • Represent Denali in internal and external scientific and medical forums.
  • Present program updates to leadership and help shape Denali’s overall oncology strategy.
  • Promote a culture of compliance, ethics, patient focus, and scientific excellence.
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