Clinical Development Medical Director, Early Development Oncology
### **职业类别**临床发展### **工作描述** **加入阿姆根服务患者的使命** 在阿姆根，如果你觉得自己是更大的一部分，那是因为你。我们共同的服务严重疾病患者的使命驱动了我们的一切。自1980年以来，我们帮助生物技术世界开拓在我们对抗世界上最艰难的疾病中的第一步。通过专注于四个治疗领域肿肿瘤学，炎症，一般医学和罕见病，我们每年都能达到数百万病人。作为阿姆根团队成员，你将帮助对患者的生活产生持久影响，因为我们研究，制造和提供创新药物来帮助人们生活更长时间，更满意的幸福。我们的获奖文化是协作，创新的，科学基础上的。如果你对挑战和它们所带来的机会充满热情，你将成为阿姆根组的一部分。加入我们并改变病人生活，同时转型你的临床发展主任职业生涯** **你会做什么**让我们这样做。让我们改变世界。在这个重要角色中，你将领导从人类研究开始的早期临床开发化合物，通过概念验证。你将与团队合作支持早期临床试验的设计和交付。通过这一职位，临床医学总监将支持协议开发，研究启动，数据审查，监测和分析活动。**责任** - 贡献对瘤治疗候选人的早期临床发展战略的设计和实施。- 协助制定临床开发计划，临床研究协议，知情同意，调查人员简单书籍和伦理委员会及监管机构的提交 - 审查并评估临床研究安全性，有效性，药力动态和药 cokinetic 数据 - 帮助策略和使用临床生物标记促进药物发展 - 与 Amgen 精准医学，研究，晚期开发，监管，安全和商业同事积极合作 - 在瘤治疗领域对外部许可或伙伴关系机会进行评估 - 与外部专家合作提供生物医学实验
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### **Career Category**
Clinical Development
### **Job Description**
**Join Amgen’s Mission of Serving Patients**
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Clinical Development Director**
**What you will do**
Let’s do this. Let’s change the world. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials. Through this role, the Clinical Medical Director will support protocol development, study start up, data review, monitoring and analysis activities.
**Responsibilities**
- Contribute to the design and implementation of the early clinical development strategy for oncology therapeutic candidates
- Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
- Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data
- Contribute to the strategy and use of clinical biomarkers to facilitate drug development
- Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues
- Contribute to the evaluation of external licensing or partnering opportunities within the oncology therapeutic areas
- Collaborate with external experts to provide biomedical expertise and strategic guidance to oncology early development teams
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Early Development professional we seek is a Leader with these qualifications.
**Basic Qualifications:**
MD or DO degree from an accredited medical school AND
2 years of industry or academic clinical research/drug development experience
**Preferred Qualifications:**
- Board certification or eligible (Oncology)
- Residency training in Oncology and relevant subspecialty
- Experience in basic research and/or clinical trial methodology
- 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials
- Experience collaborating with pharmaceutical sponsors
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Demonstrated leadership qualities; capable of conducting studies as part of a team
- Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
- Publication track record
- Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
**Sponsorship**
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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**Salary Range**
274,788.85USD -371,773.15 USD