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Job Title: Associate / Senior / Executive Director for Medical, Clinical Development - Oncology

About Laekna Therapeutics

Laekna Therapeutics is a global clinical stage biopharmaceutical company located in Hong Kong and in Shanghai, China, as well as in the east coast, USA. The mission of the company is to develop new medicines to meet the unmet medical needs through innovative science and apply the state of art new technologies. Laekna Therapeutics focuses both drug discovery and drug development for the most difficult to treat diseases, such as cancer and liver diseases.
Laekna Therapeutics is also dedicated to transforming science into value for patients by delivering distinct new molecular entities or combinational therapies for different type of cancers and liver diseases. The company pipeline contains multiple clinical stage molecules for potential combination therapy with early to late phase clinical trials conducting both in China and in the US.
This newly created position will be working on the global trials for Oncology. Laekna Therapeutics will provide competitive compensation package for the candidate (the detail Laekna Therapeutics information can be found from the website: http://www.leaknatp.com).


Job Description

Lead execution of global or local clinical studies, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH) guidelines, and the regulations in the major global regulatory agencies, such as FDA/EMA/NMPA.

Responsibilities

Lead a cross-functional study team to provide clinical development plan, study design, medical strategy;
Perform investigator/medical expert engagement, study protocol development and review, CRF/ICF/CSR/protocol amendment/IB update/safety communication/DSUR draft and review;
Work with clinical operation colleagues to manage the study budget, evaluate and manage the CRO(s), site selection and site qualification; provide input in study document draft and review, such as IND and NDA;
Lead the regulatory agency interactions and communications related to the assigned study. As the medical monitor to manage the major safety issues for assigned study.

Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan by company and CRO;
Complete a study risk assessment and ensure mitigation and contingency measure; actively assess potential risks to the study and propose mitigation plans;
Track major study milestones and monitor overall operational performance through the life of the study;
Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate senior management team.

Qualifications:


  • Advanced degrees in the Health Sciences, such as MD, PharmaD, PhD degrees are required. knowledge and training in a medical/scientific area of Oncology Medicine preferred.
  • Thorough knowledge of clinical trial design, statistical analysis methodology, and regulatory/clinical development process preferred.
  • Clinical practice experience for MD (including residency) preferred.
  • Experiences of involvement in clinical research and drug development in an academic and/or industry environment is highly valued for this role.
  • Experience in interactions with Health Authorities (e.g. FDA, EMEA, PMDA...) is a big plus.
  • Strong communication skills in both English and Chinese



Laekna Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.


Contact information:

hr@laeknatp.com