Director, Clinical Operation

  • Full Time
  • US
  • 12/31/2021

Website Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer, viral hepatitis, and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.

We value our employees as our greatest assets, and we are dedicated to providing an equal employment opportunity along with creating a positive work environment where courageous innovation is encouraged and expected. Our vision is to become a world-class biotechnology company. Our highly talented team of scientists and medical professionals are all passionately sharing this common vision, and we are excited to welcome any talented members to join the big family of Ascletis. We are looking forward to having you as a prospective member of Ascletis. If you’re interested in learning more about what we have to offer, please email your CV to hr@ascletis.com.

 

Director, Clinical Operation
JOB TYPE: Full time
LOCATION: US

 

JOB SUMMARY:
The Director of Clinical Operation at Gannex (A Member of the Ascletis Group) will supervise all clinical
research projects to ensure all affairs work smoothly

Responsibilities:

  • Oversee the implementation of clinical projects and the management of clinical studies to ensure studies are completed on time, in compliance with related regulations, guidelines, and our SOPs, study protocol, project management plan, and monitoring plan.
  • Coordinate the project progress between different departments.
  • Participate in formal staff performance review processes, drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance.
  • Develop training plans and programs across Clinical Operations to enhance project management skills, achieve the targets and build a competitive clinical research team.
  • Ensure good planning and timely delivery of clinical trials within the approved trial budget.
  • Contribute to and maintain accountability for overall Clinical Operations strategy and performance against key metrics.
  • Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact), and mitigation plans.
  • Develop, implement SOPs, and monitor departmental compliance.
  • Keep positive relationships with sponsors and investigators.
  • Establish clinical operation capability for the successful delivery of clinical trials, in partnership with related vendors.
  • Conduct clinical research or marketing research questionnaires, etc.

Requirements:

  • At least BA/BS degree; Master’s/PhD/PharmD preferred.
  • Bio-Sciences, Pharmacology, Medicine, or other health-related major is preferred.
  • At least 6 years’ clinical trial experience.
  • Experience in Nonalcoholic Steatohepatitis (NASH) is a plus.
  • Fluent in both written and oral English.
  • Knowledge of new product development, including local regulation, GCP, clinical trial operations.
  • GCP certificate.
  • Excellent communication skills including verbal, written, and presentation skills.
  • Highly developed interpersonal, relationship-building, negotiation, and conflict resolution skills.
  • Commercial acumen.
  • Experience in preparing and tracking budgets, Information-gathering skills.
  • Self-starter and able to anticipate potential problems and develop a mitigation plan.

Competency:

  • Ensure that multiple, novel ideas on how to deliver on clinical trials are generated and considered.
  • Identify opportunities and initiatives that can be adopted/adapted by Clinical Operations as best practice, equally recommend best practices within Clinical Operations that if more broadly applied would benefit Gannex as a whole.
  • Actively oversee the knowledge management process by ensuring information is captured, retained, and leveraged for future work.
  • Contribute to Clinical Operations and clinical trial sourcing strategy development and take a lead role in vendor governance.
  • Ensure alignment with broader Gannex strategic initiatives and business needs and provide recommendations or ideas on how Clinical Operations programs can generate greater value for Gannex overall.
Upload your CV/resume or any other relevant file. Max. file size: 128 MB.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.