助理总监，临床试验负责人
Associate Director, Clinical Trial Lead
在生物科技行业领先企业百健，开启你职业生涯中最有意义的篇章。这是你难得的机会，超越日常管理运营，设计运营策略并监督我们的临床研究组织（CRO）合作伙伴，制定清晰的方案概念和最终方案。最令人振奋的是：你将负责整个临床试验研究，包括运营设计、成功执行，并对患有多种神经系统疾病（包括肾病综合征、多发性硬化症（MS）、阿尔茨海默病和脊髓性肌萎缩症（SMA））患者的健康产生积极影响。你可以通过灵活的混合办公模式在家、办公室或两者兼顾地工作，你将获得一支拥有成熟流程的团队支持，助你将愿景变为现实。
**你将负责**
- 制定并监督临床研究的运营策略，以确保研究的成功执行。
- 主持研究管理团队（SMT），推动科学严谨、操作可行且清晰的概念/方案的开发。
- 监督由CRO执行的研究，确保质量执行符合时间与预算预测。
- 与CRO的SMT负责人合作，确保CRO制定适当的风控计划，并有效识别和解决问题。
- 通过建立开放文化来建立高效的团队运作，这种文化以沟通、目标设定和战略实施的监督为特点。
- 确保流程有效、一致、高效且合规。
- 在其他研究、项目和开发单元之间推动协同效应，以提升研究规划和执行的卓越性。
**你应具备**
具有科学素养和临床敏锐度，你是有使命感的人，具备战略眼光，能够看到大局，并承担远超日常运营的更广泛、更有意义的责任。果断、分析能力强且自信，你决心掌控自己的职业生涯，并通过你的领导力和激发卓越的能力，为他人的生活带来改变。
**所需技能**
- 科学学科的学士学位
- 8年以上临床运营管理工作经验，负责外包临床试验，满足质量、时间和预算要求，最好在发起公司和CRO都有相关经验
- 相关的科学和临床专业知识及经验
查看英文原文
Make the most meaningful impact of your career in this rewarding role with Biogen, a well-established pioneer in the pharmaceutical industry. This is your rare opportunity to transcend day-to-day management operations as you design operational strategy and oversee our clinical research organization (CRO) partners to develop clear protocol concepts and final protocols. The best part: You will own responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of neurological conditions, including nephrotic conditions, multiple sclerosis (MS), Alzheimer’s disease, and spinal muscular atrophy (SMA). Working from home, office, or both on a flexible, hybrid schedule, you’ll have the support of a team with well-established procedures in place to make your vision a reality.
**What You’ll Do**
- Develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
- Chair the Study Management Team (SMT) to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
- Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
- Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
- Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
- Ensure effective, consistent, efficient and compliant processes.
- Champion synergies among other studies, programs, and development units to enhance excellence in study planning and execution.
**Who You Are**
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
**Required Skills**
- Bachelors Degree in a scientific discipline
- 8 + years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO
- Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skill
- Extensive knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development
- Unquestioned expertise in Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development
- Ability to establish operational plans and support the CRO in executing them
- Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model
**Preferred Skills**
- Experience operationalizing nephrology clinical studies
- An advanced degree, such as a master’s or Ph. D in a related field
- Investigator site and/or monitoring experience
Job Level: Management
**Additional Information**
The base compensation range for this role is: $171,000.00-$236,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families _physical, financial, emotional,_ and _social well-being_; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
**Why Biogen?**
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. [Read on](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.