Sobre este puesto de Senior Clinical Trial Manager, APAC, Clinical Operations (Based in China) en Parabilis Medicines
About Parabilis Medicines
Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP) and a range of other solid tumor indications. Beyond zolucatetide, Parabilis is advancing additional Helicon-based programs focused on other challenging targets where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn.
What’s the opportunity?
Based in China and serving as a Senior Clinical Trial Manager within the Clinical Operations team, you will play a pivotal role in the planning, execution, and management of clinical trials conducted across multiple global sites. You will collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and external vendors, to ensure the successful implementation and completion of clinical trials in accordance with regulatory requirements and company standards. This individual will report directly to the Associate Director, Clinical Operations.
This role requires the individual to be based in China; relocation to China will not be offered.
The Senior Clinical Trial Manager, APAC, Clinical Operations will:
- Develop and execute comprehensive global site management plan (including timelines, budgets, and resource allocation), to ensure the successful conduct of clinical trials.
- Oversee site selection, initiation, and monitoring activities, ensuring adherence to Good Clinical Practice (GCP) guidelines, protocols, and applicable regulations.
- Coordinate with vendors, including Contract Research Organizations (CROs), central laboratories, and other service providers, to ensure quality and timely delivery of study-related activities.
- Manage trial-related documents, including protocols, investigator brochures, informed consent forms, and regulatory submissions, in compliance with regulatory requirements.
- Implement risk mitigation strategies and proactively identify and address issues and deviations to ensure the integrity and validity of clinical trial data.
- Serve as the primary point of contact for investigative sites, providing support and guidance throughout the duration of the trial.
- May function as subject matter expert for one or more clinical systems (e.g., eTMF, CTMS)
- Contribute to the development and implementation of process improvements and best practices within the Clinical Operations function.
- Keep abreast of industry trends, regulatory guidelines, and emerging technologies to enhance clinical trial execution strategies.
What you’ll need to be successful:
- B.S./B.A. in life science or related field
- 6+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry.
- Phase 1-3 Oncology experience required
- Phase 1-3 global trial management experience required
- Direct experience overseeing global CROs and other study vendors
- Experience with APAC region, including China (required) and Taiwan, Hong Kong, Japan and South Korea (a plus)
- Solid attention to detail and excellent organizational skills
- 3+ years on-site monitoring experience preferred
- Strong interpersonal and communication skills (both written and oral)
- Supportive team member with a willingness and ability to fill functional gaps in a small but growing organization
- Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
- Creative problem-solving skills
- Self-motivated and adaptable in a dynamic, nimble, start-up environment
- Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT and EDC platforms
- Ability to work cross culturally and with a variety of time zones
- Ability to work independently, prioritize tasks, and adapt to changing priorities in a fast-paced environment.
Core Values
Parabilis is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.
- Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
- In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.
The base salary target for this position is $130,000-$155,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.
As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com