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Headquarters: Building F2, 88 Kechuang, 6th St., Beijing , China
Beijing Office : Suite 2105, Building T2, Dazu Square, Beijing , China
Shanghai Office: 595 North Caoxi Road Building A Suite 6009 , Shanghai China
Boston Office: 99 Hayden Ave, Lexington, MA 02421, US
Tel: +86 010-56315466
Fax: +86 010-56315314
1 Develop and implement clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team, leading discussions, and revisions of study design with internal stakeholders and external experts/consultants.
2 Work closely with project teams and the Translational Biology group to identify preferred therapeutic directions and patient selection strategies.
3 Develop a deep understanding of the clinical and competitive environment and work with teams to develop target product profiles for projects in both research and development.
4 Serve as the medical lead for clinical protocols.
5 Partner with Clinical Operations on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting and protocol deviations.
6 Support high-quality cleaning, analysis, interpretation, and communication of data in ongoing and completed studies.
7 Co-author regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts, and presentations.
8 Participate in regulatory authority interactions, as necessary.
9 Develop productive relationships with external key opinion leaders and investigators and lead/participate in investigator meetings, advisory boards, and site visits.
10 Work and partner with internal and external (CRO, investigator) stakeholders
11 Adhere to and implement quality standards and SOPs in clinical development.
1 MD or MD/PhD with at least 3 years’ experience in drug development.
2 Sub-specialty training or board certification in oncology, hematology or immunology preferred.
3 Experience in Phase I protocol development and clinical strategy development is required.
4 Industry experience is strongly preferred, although academic candidates with significant relevant experience in clinical trials and strategic development will also be considered.
5 Knowledge of the regulatory environment and experience with working with regulatory authorities is preferred.
6 Strong ability to integrate biological knowledge into clinical development strategy.
7 A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented, and dynamic environment.
8 Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential.
9 Strong written and verbal communication skills.
10 Ability to travel.