Sr Director, Clinical Development- CAR-T (MD)
Gilead Sciences, Inc., California, Maryland, United States, 20619
Sr Director, Clinical Development- CAR-T (MD)
Position overview: Senior physician-lead role providing clinical oversight to multiple CAR-T trials, guiding project teams to design and execute high-quality clinical studies within regulatory and corporate guidelines. Job Description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we\'re not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. 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, take 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? The salary range for this position is: $274,550.00 - $355,300.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Equal Employment Opportunity
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics. Reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act, the Vietnam Era Veterans\' Readjustment Act, and the Americans with Disabilities Act may be requested via ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Important Notices
Kite Pharma will not discharge or discriminate against employees or applicants for discussing pay, but any disclosure of compensation information must comply with company policy. Our environment is free of harassment and promotes diversity of thought and opinion. This description reflects the position as of the date indicated and is subject to change. Apply via the Internal Career Opportunities portal in Workday if you are a current Kite Pharma employee or contractor. Job Requisition ID R0048424. Full Time/Part Time: Full-Time. Job Level: Director.
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Position overview: Senior physician-lead role providing clinical oversight to multiple CAR-T trials, guiding project teams to design and execute high-quality clinical studies within regulatory and corporate guidelines. Job Description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we\'re not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. 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, take 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? The salary range for this position is: $274,550.00 - $355,300.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Equal Employment Opportunity
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics. Reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act, the Vietnam Era Veterans\' Readjustment Act, and the Americans with Disabilities Act may be requested via ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Important Notices
Kite Pharma will not discharge or discriminate against employees or applicants for discussing pay, but any disclosure of compensation information must comply with company policy. Our environment is free of harassment and promotes diversity of thought and opinion. This description reflects the position as of the date indicated and is subject to change. Apply via the Internal Career Opportunities portal in Workday if you are a current Kite Pharma employee or contractor. Job Requisition ID R0048424. Full Time/Part Time: Full-Time. Job Level: Director.
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