临床科学总监
Director, Clinical Science
部门：
106750 临床开发
地点：
美国圣地亚哥 - 远程
加入一个全球团队，我们致力于改善罕见病患者的生活。
在Travere Therapeutics，我们认识到优秀的员工是公司成功的关键。我们是一支专注于满足罕见病患者独特需求的团队。我们的工作既具有专业价值，也充满个人意义，因为我们正在带来改变。我们对所从事的工作充满热情。
我们正在寻找能够在协作、多元化、快节奏环境中茁壮成长，并与我们共同实现使命的人才——为患有罕见病的人群发现、开发并提供改变生命的疗法。我们坚持以患者为中心、勇气、社区和合作为核心价值观，追求成为一家领先的生物制药公司，致力于为全球罕见病患者带来创新和希望。
在Travere Therapeutics，我们为生命而努力。我们继续勇敢地探索新路径，朝着提升科学与服务以造福罕见病患者这一共同目标前进。
职位概述：
临床科学总监将为Travere正在进行的和未来的肾脏病开发及临床项目生命周期活动提供管理和支持。该职位将与跨职能多学科研究团队合作，参与临床试验设计与执行，以及相关的转化和临床数据分析、解释和展示，同时确保遵循良好临床实践（GCP）。
职责：
- 协助设计和实施临床研究（包括人体药理学研究）及数据分析。
- 协助报告临床试验的安全性和有效性数据。
- 与团队成员合作，确保遵循良好临床实践（GCP）。
- 作为负责人，与其他临床开发和临床药理学团队成员、内部和外部合作者以及统计人员一起撰写临床和数据分析报告、幻灯片演示、clinicaltrial.gov 摘要等。
- 参与IND、新药申请（NDA）和生物制品许可申请（BLA）中的临床、科学和作用机制部分，包括方案、SAP、模拟TFL、研究者手册、医学报告、有效性和安全性摘要、科学依据、获益/风险比、监管简报手册等内容。
查看英文原文
Department:
106750 Clinical DevelopmentLocation:
San Diego, USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Director, Clinical Science, will provide management and support for Travere’s on-going and future nephrology development and life-cycle activities for clinical programs. The position will work with cross-functional multidisciplinary study teams on clinical trial design and execution as well as related translational and clinical data analyses, interpretation, and presentation of data while ensuring that Good Clinical Practices (GCPs) are followed.
Responsibilities:
- Assist in design and implementation of clinical studies (including human pharmacology studies) and data analyses.
- Assist in reporting clinical trial data for safety and efficacy.
- Collaborate with team members to ensure Good Clinical Practices (GCPs) are followed.
- Leadership position for writing clinical and data analysis reports, slide presentations, clinicaltrial.gov summaries, etc. with other clinical development and clinical pharmacology team members, internal and external collaborators, and statistical staff.
- Contribute to clinical, scientific, and mechanism of action portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responding to information requests from regulators.
- Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders to optimize performance on clinical activities and collaborations.
- Prepare manuscripts for scientific and medical journals as well as prepare and present at scientific meetings.
Education/Experience Requirements:
- PhD, PharmD, and/or MD in related Life Science discipline required; experience in rare disease and/or nephrology preferred.
- 6 years of experience in the pharmaceutical industry; equivalent combination of education and applicable job experience in academic or other setting may be considered.
- Experience working on clinical trials and clinical studies required; experience with human pharmacology studies preferred.
- Experience contributing to INDs, NDAs, BLAs, and regulatory information requests strongly preferred.
Additional Skills/Experience:
- Strong organizational abilities, high attention to detail, and excellent presentation skills.
- Driven, intelligent, passionate about making a difference for patients with rare diseases.
- 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.
- Demonstrated ability to review, interpret and present complex scientific data.
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
- Strong interpersonal and outstanding verbal and written communication skills are required.
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
- Ability to travel 15% domestically and internationally.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$206,000.00 - $268,000.00*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to . Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
Originally posted on Himalayas