Director of MedicaI Research

Website InnoCare Pharma Inc. (US)

 

InnoCare Pharma is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing best-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases.

InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline target liquid tumors, solid tumors, and autoimmune diseases. Our team has discovered and developed our current pipeline of over 10 novel drug candidates, including our core product candidate Orelabrutinib, whose NDA was accepted and granted priority review by the NMPA earlier this year.

InnoCare was co-founded by Professor Shi Yigong, a world-renowned structural biologist, and Dr. Cui Jisong, an outstanding leader in the biopharmaceutical industry. We have nearly 300 employees, including over 100 researchers. Our core R&D staff brings rich experience from the world’s top pharmaceutical companies, such as Pfizer, Bristol-Myers Squibb, Merck, Johnson & Johnson, Bayer, etc. We are a truly global biopharmaceutical company with sites in Beijing, Nanjing, Shanghai, and Guangzhou, in addition to branches in New Jersey and Boston for US development and clinical management.

On March 23, 2020, InnoCare was officially listed on the Hong Kong Stock Exchange (code: 9969). Our vision is to become a world-class leader in innovative medicine and lead China’s medicinal research into a new era.

 

Director of MedicaI Research

JOB TYPE: Full-time

Location: New Jersey or Boston Area, US

 

Key Responsibilities:

  1. Clinical trial design and study report: from FIH study to pivotal trials in the field of oncology and autoimmune diseases in the US, including protocol development and amendment, clinical study report, medical-related regulatory documents (IND and NDA), review of other related study documents, IB, CRF, ICF, SAP, etc;
  2. Medical monitoring during clinical trials, including MMP development, eligibility review; data listing, coding list, AE and SAE review/report; data summary and potential risks report.
  3. Medical support and training during the clinical trials: provide protocol and medical training to operation team as required and answer clinical and protocol queries from sites, prepare and lead investigator’s meeting, regulatory submission, and FDA communications/meetings.
  4. KOL management: Communications with key opinion leaders timely, seeking advice for the clinical development plan, and maintain good communication for trial data and progress in the field.
  5. Professional meetings and publications: attending professional meetings of related field and presentation of clinical

 

Requirements:

  1. Doctorate in Medicine or in Life Sciences-related majors;
  2. Good communication skills with at least 5 years of experience in clinical trials in the field of oncology or autoimmune disease treatment, with successful records from protocol design to full completion of Phase I-II-III clinical trials;
  3. Comprehensive and in-depth understanding of the whole process of clinical trials of new drugs, including design, implementation, and statistical/data management of clinical trials;
  4. Good understanding of GCP and ICH guidelines, experiences with regulatory submissions preferred.
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