About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an innovative emerging Biotech company based in China’s “Zhangjiang Pharma Valley” and in New Jersey in the US, focused on developing ground-breaking innovative therapeutics to treat cancer and liver diseases.

Laekna Therapeutics is adopting a two-pronged strategy in new drug development. First, it continues to enrich its portfolio by introducing new drugs with the clinical Proof of Concept. The company has obtained the exclusive global rights of four new drug candidates from Novartis. In addition, the company has established internal discovery platforms for cancer and liver diseases and will soon have self-developed candidates entering clinical stages.

Laekna has established a team of top global pharmaceutical talent and acquired key technologies. Its leadership team has over 20 years of experience in new drug development in China and the US, with an exceptional track record in R&D, new drug approvals and commercialization. In order to benefit patients, Laekna is committed to a science-based, innovation-driven approach to creating a leading clinical research and development pipeline, and developing first-in-class and best-in-class innovative drugs.

The detail Laekna Therapeutics information can be found from the website: http://www.leaknatp.com.

Job Overview

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.

Main 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:

1.Advanced degrees in the Health Sciences, such as MD, Pharma D, PhD degrees are required. knowledge and training in a medical/scientific area of Oncology Medicine preferred.

2.Clinical practice experience for MD (including residency) preferred.

3.Experiences of involvement in clinical research and drug development in an academic and/or industry environment is highly valued for this role.

4.Experience in interactions with Health Authorities (e.g. FDA, EMEA, PMDA...) is a big plus.

5.Thorough knowledge of clinical trial design, statistical analysis methodology, and regulatory/clinical development process preferred.

6.Communication with English and Chinese is a big plus.

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.