临床主任,临床研究,血液学
Clinical Director, Clinical Research, Hematology
**职位描述**
临床总监(高级科学家)主要负责规划和指导涉及新药或已上市药物的肿瘤治疗领域的临床研究活动,特别是在我们的血液学部门。我们公司的肿瘤药物涵盖所有临床开发阶段(从临床前到上市后)。临床总监可能负责其指定研究的整个临床开发周期,包括研究设计、启动、执行、监测、分析、监管报告和发表。
**岗位职责:**
**具体而言,临床总监可能负责:**
- 根据临床开发策略规划临床试验(设计、协作制定操作计划等)。
- 对正在进行或新的临床试验进行医学监督和整体管理,针对研究药物或已上市药物。
- 分析和总结研究中的临床发现,以支持安全性、有效性决策以及新药申请、临床研究报告或发表。
- 参与与新化合物开发及已上市化合物进一步研究相关的内部和联合内部/外部研究项目团队。
- 支持对外部机会的业务发展评估。
**临床总监可能:**
- 积极与其他职能领域合作,以支持研究的执行。
- 与商业化、法规事务、统计学和制造等跨职能专家小组密切合作,以管理临床开发项目。
- 协助团队确保其他同事了解本公司及竞争对手药物的研究进展。
- 在内部和外部就其职责范围内的相关科学问题提供专业意见。
**临床总监负责通过以下方式保持扎实的科学知识基础:**
- 保持对其专业领域内科学发展的关注,包括新科学发现和研究方法。
- 识别在科学和操作方面强大的研究人员,以协助本公司研究药物和已上市药物的开发。
- 与自己特定兴趣领域的著名临床研究人员建立沟通,特别是那些愿意并能够协助评估本公司药物的人。
- 参加审批会议
查看英文原文
**Job Description**
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
**Role Responsibilities:**
**Specifically, the Clinical Director may be responsible for:**
- Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy.
- Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
- Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication.
- Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
- Supporting business development assessments of external opportunities.
**The Clinical Director may:**
- Actively engage with other functional areas in support of study execution.
- Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs.
- Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.
**The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:**
- Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies.
- Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs.
- Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs.
- Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
**To accomplish these goals, the Clinical Director may:**
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers around the world.
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
**Education:**
- M.D or M.D./Ph.D.
**Required Experience and Skills:**
- Must have experience in industry or senior faculty in academia.
- Minimum of 3 years of clinical medicine experience.
- Minimum of 1 year of industry experience in drug development or biomedical research experience in academia.
- Demonstrated record of scientific scholarship and achievement.
- Proven track record in clinical medicine and background in biomedical research.
- Strong interpersonal skills, as well as the ability to function in a team environment.
- Strong verbal and written communication and presentation skills.
**Preferred Experience and Skills:**
- Board Certified or Eligible in Oncology, Hematology or related discipline.
- Prior specific experience in clinical research and prior publication.
**Required Skills:**
Academic Presentations, Adaptability, Allergy and Immunology, Biomedical Research, Clinical Investigations, Clinical Judgment, Clinical Research, Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Ethical Standards, Intellectual Curiosity, New Technology Integration, Regulatory Requirements, Scientific Consulting
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [click here](https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
[EEOC Know Your Rights](https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
[EEOC GINA Supplement](https://www.eeoc.gov/gina-genetic-information-nondiscrimination)
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
[Learn more about your rights, including under California, Colorado and other US State Acts](https://www.msdprivacy.com/us/en/CCPA-notice/)
The salary range for this role is
$255,800.00 - $402,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at [https://jobs.merck.com/us/en/compensation-and-benefits](https://jobs.merck.com/us/en/compensation-and-benefits).
You can apply for this role through [https://jobs.merck.com/us/en](https://jobs.merck.com/us/en) (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
10/9/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**