Medical Director Clinical Development, Hepatology

  • 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.

 

Medical Director Clinical Development, Hepatology
JOB TYPE: Full-time
LOCATION: US

Responsibilities:
1. Cross-Functional Team Membership & People Management:

  • Participate in the relevant Therapeutic Team (TT)
  • Represent CD in Study Team relevant to the assigned molecule(s)/indication(s) and help ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

2. Clinical Development Planning:

  • Support Team in the implementation of all relevant studies and programs:
  • Participate in ongoing TT and relevant study team meetings, other interactions, and communications
  • Develop innovative clinical study designs for review and discussion. Conduct appropriate literature searches
  • Develop consistent language and criteria for informed consent form ICF, protocol, case report forms (CRF), CRF instructions, etc.
  • Review and/or write additional medical documentation and/or provide medical input as requested or needed, e.g. protocol synopsis, safety monitoring plans, process documents, investigator brochures, or other relevant presentations or materials.
  • Conduct ongoing reviews of medical/safety data
  • Collaborate with clinical operations to develop and implement the overall data quality plan
  • Contribute to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents.
  • Consistently comply with, and ensure the same among relevant CST members, all governing laws, regulations, Gannex Standard Operating Procedures (SOPs), and other guidelines

3. CRO Management:

  • Function as the medical monitor of clinical studies and works closely with the CRO to achieve study timelines and goals

Requirements:

  • At least MD, DO, Pharm D, or Ph.D.
  • At least 3 years’ pharma/biotech industry experience. At least 3 years experience with clinical trials.
  • Experience in Nonalcoholic Steatohepatitis (NASH) is a plus.
  • Fluent in English.
  • General familiarity with biostatistics; expert in a wide range of clinical trial designs, navigating scientific literature, interpretation of data, display of data.
  • Excellent communication and coordination skills. Value importance of teamwork.
  • Good understanding, good working, and proactive attitude.
  • Information-gathering skills.
  • Good sense of responsibility, dedication, honesty, and self-discipline.
  • Self-starter and able to anticipate potential problems and develop a mitigation plan.
  • Proficient in Microsoft Word and Powerpoint.
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