临床开发总监(医学博士)
Director, Clinical Development (MD)
我们只有一个目标——治愈癌症。每一刻都在致力于开发治疗方案,每一步都在向目标更进一步。我们取得了令人瞩目的科学突破,开创性的个性化CAR-T细胞疗法已经改变了行业格局。但我们的工作还没有结束。
加入Kite,我们在癌症治疗领域取得更大的进展,帮助塑造公司和医学科学的未来。
我们相信每位员工都值得拥有优秀的领导。人员领导者是Gilead和Kite员工体验的核心。无论现在还是未来担任人员领导者,你都是推动文化演变的关键力量,创造一个让每位员工感到被包容、被发展、被赋予权力以实现自身抱负的环境。加入Kite,一起创造更多明天。
职位描述
医学总监为一项或多项临床试验提供临床监督和医学监测,并以高质量、高效、低成本的方式参与临床研究的设计与执行,符合部门目标、监管要求和资源限制。该职位在研究层面有重要职责,并有机会获得企业层面的战略和组织领导视野。
职位职责
- 为神经科和/或自身免疫疾病领域的1项或多项临床试验提供临床监督和医学监测。
- 与高级临床领导者及跨职能合作伙伴合作,参与临床研究的设计与实施,包括早期阶段和概念验证试验。
- 撰写和/或审核方案、方案修订、研究者手册、临床研究报告、知情同意书、安全叙述及其他临床试验文件。
- 参与研究者会议、机构参与活动以及选定的机构启动活动,与临床试验研究者合作。
- 通过识别研究风险、提出缓解措施并协助跟踪关键里程碑、交付成果和成本意识的研究决策,支持临床开发计划的执行。
- 解读研究成果、转化研究和非临床研究的发现,并帮助将其转化为临床开发机会。
- 与研究者、关键意见领袖和其他外部专家互动,以支持方案开发、研究实施和数据解读。
- 与内部法规事务、安全、临床等团队合作。
查看英文原文
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 Description
The Medical Director provides clinical oversight and medical monitoring for one or more clinical trials and contributes to the design and execution of clinical studies in a high-quality, time- and cost-effective manner consistent with departmental goals, regulatory requirements, and resource constraints. This role has meaningful study-level ownership with the opportunity for enterprise-level strategic and organizational leadership visibility.
Job Responsibilities
- Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease.
- Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials, in collaboration with senior clinical leaders and cross-functional partners.
- Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents.
- Participate in investigator meetings, site engagement activities, and selected site initiation activities with clinical trial investigators.
- Support execution of clinical development plans by identifying study risks, proposing mitigations, and helping track milestones, deliverables, and budget-conscious study decisions.
- Interpret findings from research, translational, and nonclinical studies and help translate them into clinical development opportunities.
- Interact with investigators, key opinion leaders, and other external experts to support protocol development, study conduct, and data interpretation.
- Partner with internal Regulatory Affairs, Safety, Clinical Operations, Biometrics, Translational Sciences, Medical Writing, and other functions to support high-quality study execution and regulatory compliance.
- Provide clinical input to regulatory submissions and responses to health authority questions in the context of INDs, clinical trial applications, and later-stage planning.
- Contribute clinical guidance in interactions with external stakeholders, including advisory boards and patient advocacy organizations, and with internal stakeholders across Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial as appropriate.
- May present scientific or clinical data at investigator meetings and scientific congresses and may contribute to abstracts, presentations, and publications.
- May support due diligence or clinical evaluation of external opportunities as needed.
Basic Qualifications
· MD or DO required.
- Approximately 2 to 5 years of clinical, scientific, and/or drug development experience in biopharma, academia, healthcare, or related settings.
- Working knowledge of clinical trial design, protocol development, safety review, and Good Clinical Practice.
- Ability to function effectively in a matrixed, cross-functional team environment.
Preferred Qualifications
- Board certified or board eligible in Neurology.
- Training and clinical expertise in neurology, neuroimmunology, or autoimmune neurologic disease.
- Drug development experience in neurology, autoimmune disease, cell therapy, immunology, or other advanced therapeutics, either within industry or as a clinical investigator / physician-scientist.
- Experience supporting Phase 1, Phase 1b/2, or proof-of-concept studies; prior first-in-human exposure is desirable but not required.
- Demonstrated ability to contribute to study design, study conduct, and emerging data interpretation.
- Strong clinical judgment, scientific rigor, and problem-solving skills.
- Effective written and verbal communication skills and the ability to work with appropriate independence while escalating issues thoughtfully.
- Ability to build productive working relationships with internal colleagues, investigators, and key thought leaders.
- Comfort operating in a fast-paced and evolving development environment.
- May travel up to 25%
- TBD
- The salary range for this position is:
- Bay Area: $261,375.00 - $338,250.00.Other US Locations: $237,575.00 - $307,450.00.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*.
- For additional benefits information, visit:
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
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Kite Pharmais 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 or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Kite Pharmaprovides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Originally posted on Himalayas