Sr Director, Clinical Development- CAR-T (MD)

Arbeitsbeschreibung

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

As a Senior Medical Director, you will provide clinical oversight to multiple clinical trials. Additionally, the Senior Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.

Job Responsibilities

• Provides ongoing medical monitoring for multiple clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.

• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.

• Lead project teams to design and implement clinical studies.

• Write protocols, investigator brochures, 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 team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.

• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner.

• Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs.

• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures.

• Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial).

• May present scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.

• May assist in the clinical evaluation of business development opportunities.

Basic Qualifications

• MD/DO and 6+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia

Preferred Qualifications

• Board certification/specialization in hematology or oncology

• CAR-T therapeutic area experience

• Multiple myeloma disease area expertise, with experience managing Phase II or III studies experience in multiple myeloma CAR-T trials within the pharmaceutical industry.

• Drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience; drug development experience in hematology or oncology.

• Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.

• Ability to think analytically and strategically to formulate, develop, and execute clinical plans.

• Strong leadership skills with an ability to set vision, lead change, and mentor others.

• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.

• Excellent scientific written and oral communication skills.

• Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.

• Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.

• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected).

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us?