Sobre este puesto de CLINICAL TRIAL MANAGER en Adicet Bio
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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Shanghai Adicet Biotechnology Co., Ltd. is a clinical stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Shanghai Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. The pipeline developed by Shanghai Adicet was discovered and is being developed outside of China by Adicet Bio, please visit https://www.adicetbio.com for additional details on the pipeline.
Onsite in Shanghai, China
Clinical Trial Manager (CTM)
We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) to join our dynamic China clinical operations team. This role is critical for the successful execution of our international Phase I/II clinical trials in China. The ideal candidate will be a hands-on professional who thrives in a fast-paced, global biotech environment. You will serve as the key person to oversee local vendors, ensuring seamless study implementation and delivery.
Key Responsibilities:
- Global Study Execution:As the local CTM to collaborate with US Headquarter to implementation of global Phase I/II clinical trials in China, ensuring compliance with the global study protocol, ICH-GCP, and local regulatory requirements. May serve as an independent CTM to manage China standalone trials.
- Vendor Management:Select, manage, and oversee local vendors, including CROs, SMOs, and Investigational Product (IP) depots, to ensure high-quality delivery within agreed timelines and budgets.
- Cross-Functional Collaboration:Work closely with the US-based global study team, contributing to study planning and providing timely updates on China-specific progress, challenges, and risks.
- Site Management:Collaborate with key site staff to facilitate site initiation, patient recruitment, data quality, and overall site performance.
- Budget and Timeline Management:Manage the local country budget and ensure study milestones are met. Proactively identify and mitigate risks to the study timeline.
- Quality and Compliance:Ensure all clinical activities adhere to standard operating procedures (SOPs), GCP, and applicable regulations. Lead or contribute to internal and vendor audits/inspections as needed.
- Problem Solving:Quickly identify issues and implement effective, practical solutions to keep the study on track.
Qualifications and Experience
- Education:Bachelor’s degree or higher in a life sciences or related field
- Experience:1-3 years of direct, hands-on experience in clinical operations within the pharmaceutical industry, with a proven track record of managing clinical trials in China.
- Therapeutic Area:Strong experience in Oncology and/or Autoimmune Diseases is highly preferred.
- Trial Phase Expertise:Practical experience managing Phase I and/or Phase II clinical trials are highly preferred.
- Biotech Background:Prior experience working in a biotech or small-to-mid-size pharmaceutical company is strongly preferred, with an appreciation for the agile and hands-on culture.
- Vendor Management:Demonstrated success in managing and overseeing CROs and other third-party vendors.
- Language Skills: Fluent in English and Mandarin, with excellent verbal and written communication skills.
Adicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.
We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.
To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.
We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
