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Kite Pharma

Develops engineered T cell cancer therapies

Senior Medical Director - Clinical Development-Neurology

Biology & BiotechConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • MD or DO and 6 or more years of clinical research or drug development experience.
  • Board certification or specialization in neurology and experience managing Phase 1–3 trials; late-stage experience is preferred.
  • Four or more years of relevant drug development experience in industry or as a clinical investigator or physician scientist in academia, or equivalent experience; drug development experience in neurological diseases, including neuro-autoimmune diseases, is highly desired.
  • Demonstrated clinical development strategy experience designing, implementing, and conducting clinical trials, particularly proof-of-concept and first-in-human studies.
  • Strategic leadership and tactical skills, initiative, and judgment.
  • Ability to develop and maintain working relationships with internal colleagues and external contacts, including key thought leaders and investigators.
  • Ability to work collaboratively in cross-functional teams.
  • Ability to communicate and work independently with scientific and technical personnel.
  • Critical thinking, troubleshooting, and problem-solving skills.
  • Self-motivation and willingness to accept responsibilities beyond the initial job description.
  • Comfort working in a dynamic small-company environment with minimal direction and adjusting workload as priorities change.

Responsibilities

  • Provide clinical oversight and medical monitoring for one or more clinical trials.
  • Lead project teams in designing and implementing high-quality clinical studies in a time- and cost-effective manner, consistent with department and corporate goals and regulatory and resource guidelines.
  • Write protocols, investigator brochures, and clinical study reports, and review clinical trial documents.
  • Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
  • Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
  • Translate findings from research and nonclinical studies into clinical development opportunities.
  • Interact with clinical investigators and thought leaders.
  • Work with internal regulatory affairs teams and applicable ethical guidelines for the pharmaceutical industry, and ensure compliance with external guidelines.
  • Work cross-functionally with internal preclinical scientists, translational scientists, business organizations, and commercial organizations.
  • Work with clinical operations, biomarker specialists, contract research organizations, and regulatory affairs.
  • Provide clinical expertise and input for regulatory filings, including biologics license applications and marketing authorization applications, and respond to regulatory-authority questions concerning investigational new drug submissions, clinical trial applications, or filing procedures.
  • Provide clinical guidance in interactions with external stakeholders, including medical experts, advisory boards, and patient advocacy groups, and internal stakeholders across Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial.
  • May present scientific information at scientific conferences and clinical study investigator meetings and, where applicable, lead scientific publication authorship.
  • May assist in the clinical evaluation of business development opportunities.
  • Create inclusion by modeling it and embedding the value of diversity in the management of teams.
  • Develop talent by understanding employees’ skills, experience, aspirations, and potential, coaching them on performance and future potential, and ensuring they receive feedback and insight to grow and develop.
  • Empower teams by aligning team goals and purpose with organizational objectives, holding teams accountable, removing barriers, and connecting teams to the broader organization.

About the Company

Kite Pharma

Develops engineered T cell cancer therapies

Kite Pharma develops cancer immunotherapies by engineering a patient’s own T cells to attack tumors. Its core product strategy centers on cell therapy where T cells are genetically modified to recognize cancer cells, expanded outside the body, and then infused back into the patient to destroy cancer. This approach differs from traditional drugs by using the immune system itself to fight cancer and by tailoring therapies to individual patients. Kite focuses on clinical trials and commercialization of approved therapies, often through partnerships and licensing with other pharmaceutical companies to reach patients worldwide. The company’s goal is to provide potentially lifesaving, durable cancer treatments and move toward a cure for cancer.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Santa Monica, CA
Founded
2009

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