Clinical Development Head - Oncology - China
Round C biotech oncology and unmet medical needs
Phase I and II Clinical trials
About Our Client
Our client is Round C local biotech company. Established in 2016 with Angel investment by a team of Research from TOP 10 global pharma companies, the Company currently manages a pipeline of 11 assets - 6 oncology assets in clinical stage (chemicals and anti bodies) - 3 oral drug candidates in Phase I and Phase II in China and US with NDA filing planned at 2022 and 5 early discovery assets in unmet medical needs area. This year the Company will also announce 2 more in-licences assets from global pharma partner.
- Drive the delivery of clinical development activities for a clinical stage program in Oncology part of company portfolio and ensure consistency with clinical development strategy for regulatory approvals and successful life cycle management.
- Lead multi-disciplinary clinical matrix team and major contributor to integrated clinical development strategy and Clinical Development Plans
- Contribute to the medicine development strategy
- Assures clinical studies are conducted effectively in partnership with Local Operating Company, alliance partners and Clinical Operations colleagues and CRO as appropriate
- Lead clinical study teams in development and conduct of clinical studies
- Lead authoring of study protocols, CRF's and contribute to development of analytical plans through discussion with matrix team members. Reviews standard format data displays in protocols and CRF's to assure consistency in data capture.
- Accountable for authoring of clinical study reports and Investigator Brochures.
- Assist in producing materials for Investigator meetings.
- Participate in data review discussions and contribute to data interpretation
- Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA)
The Successful Applicant
- Advanced degree in life sciences or allied field (PhD, Master level preferred)
- 10+ years of experience in the pharmaceutical industry
- Experience in clinical program management, clinical development strategy and study design/trial management and reporting is a must
- Must have demonstrated experience with major regulatory submissions in China (IND, NDA)
- Track record in CRO management
- Proven track record in leading multi-functional teams and ability to demonstrate effective leadership of global teams
- Oncology area experience in highly preferred
- Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise; proven ability to interpret complex clinical data
- Possesses sound operational knowledge of the pharmaceutical industry and broader R&D processes including scientific activity impacting project work.Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
- * Demonstrates a proven ability to both independently complete and lead peers in completion in components of complex plans, i.e. draft protocols, selecting appropriate methodologies, measures, analytical plans and evaluation tools.
What's on Offer
This is an exciting opportunity for candidates looking for a Career in biotech rather than a job. You will be offered competitive salary package, bonus and stock option with the company.