Duties & Responsibilities:

1.Propose short-term and long-term development plan of new partnership sites in China. Discuss with sites about general portfolio & upcoming studies to ensure sites engagement on studies where they deliver according to network/partner sites objectives.

2.Work as internal strategic partner with study team to mobilize internal and external resources to develop strategy of site set up and recruitment, and drive team to achieve related goals.

3.Coordinate the team to build up the strategic collaboration with key sites, to ensure good long-term relationship with study sites; streamline the working processes and improve the efficiency of work at site level.

4.Participate into specific site selections to ensure qualified and productive sites are selected according to product development strategy. Recommend which sites should be or not be selected according to recent progress of ongoing clinical trials and current site resources (human, facilities, patients, etc.) conditions. Work with CPL to finalize the study site list according to summarizing site selection results when encountering internal and external competitive studies or in an even more complicated environment.

5.Summarize and analyze overall network/partner site activity and performance using the appropriate tools, propose action and recommend correction plan accordingly, or decide any changes of network sites/partnership site pool. Participate in site initiation visit and conduct co-monitoring visit (as alternative to line manager or clinical project leader) to help patient recruitment and KOL contact on track in case of performance concerns.

6.Regularly maintain and engage site network.

7.Work together with internal team, liaise with the key stakeholders, collect and update site information timely.

8.Support and cooperate with study team on the strategy for optimizing the resource allocation of clinical trials and improving the process at site level such as site setup, activation, patient recruitment, DBL, inspection readiness, etc.

9.Work with cross functions to support clinical operations on specific issue resolution.

10.Centralizing manage and monitor patient recruitment or SSU vendor’s performance to support ongoing study deliver on schedule. And continuing develop strategic partner for SSU and recruitment.

Required Knowledge, Skills and Abilities：

1.Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.

2.5 years + experiences in clinical trial and demonstrate tracking records in site set up and recruitment.

3.Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

4.Good knowledge of relevant local regulations.

5.Required soft skills: excellent communicator, effective presentation skills, good interpersonal skills, ability to work within a team setting, ability to quickly build relationships and trust.

6.Team player willing to cooperate with other functional teams.

7.Critical thinking & problem solving.

8.Good command of English (written and spoken).

9.Proficiency in general systems and applications such as PowerPoint, Word, Excel and Adobe.

10.Ability to travel nationally as required.

About Laekna Therapeutics

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

Laekna Therapeutics is adopting a two-pronged strategy in new drug development. On the one hand, it continues to enrich its portfolio by introducing global new drugs with the clinical Proof of Concept. The company has obtained the global exclusive rights of four new drug candidates from Novartis. On the other hand, the company’s self-developed innovative drugs will soon enter clinical development stages.

Laekna has set up a team of top global pharmaceutical talent and acquired key technologies. Its leadership team members have 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. Laekna is committed to a science-based, innovation-driven approach to create a leading clinical research and development pipeline, and develop first-in-class and best-in-class innovative drugs. It has been developing an international leading platform for new drug research and development to benefit patients.

The detail Laekna Therapeutics information can be found from the website:

http://www.leaknatp.com.