Medical Director, Cardiovascular Clinical Research
HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
Reporting into HUYABIO’s Global Head of Research and Development, the Medical Director is tasked with providing subject matter expertise and medical monitoring of clinical trials and/or drug development programs targeting cardiovascular diseases. The ideal candidate will have clinical experience in cardiology or metabolic diseases and a proven track record of success leading clinical trials within academic, biotechnology or pharmaceutical industries. This track record should include clinical trial strategy and tactics, positive and productive interactions with Medical Experts and Investigators and/or industry KOL’s, interpretation of clinical trial data, medical monitoring of phases I though IV clinical trials, and working within a dynamic, global and cross-functional environment.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and its global office sites is essential.
Primary Duties and Responsibilities
- Serve as the clinical study lead and source of medical guidance for HUYABIO’s clinical project teams
- Influence strategic decisions regarding therapeutic indications for new drug candidates from Phase 0 through to Phase 2a proof of concept
- Provide medical input into strategies behind the design, planning, initiation and completion of clinical trials
- Provide medical input in the preparation of medical components of clinical trial and regulatory documents
- Partner with Regulatory Affairs, Pharmacovigilance, Quality Assurance, Clinical Operations, Pre-clinical R&D, Biometrics and Senior Management teams to formulate and implement strategic clinical trial plans
- Medical monitoring/reporting and working with company safety officer to ensure adherence to regulatory requirements, review and evaluate preclinical and clinical study safety, pharmacokinetic, pharmacodynamic, and efficacy data.
- Actively interact with clinical sites and investigators regarding study implementation
- Perform product safety medical reviews for assigned investigational drugs
- Provide SME-level input to decisions that have medical, scientific and future marketing implications
- Establish and maintain relationships with KOL’s in the area of cardiovascular diseases
- Actively contribute to in-licensing evaluations and due-diligence activities as required
Job Qualifications and Requirements
- MD or equivalent degree is required
- Successful completion of post-graduate training or Fellowship in Cardiology is required. Board Certified or Board eligibility also required.
- Previous experience in Cardiovascular medical practice/patient care highly preferred
- Expert knowledge and expertise of Cardiac and Cardiovascular diseases
- 2+ years of of experience within clinical research, clinical development or clinical science within a biotechnology or pharmaceutical setting
- Strong knowledge of early drug development and clinical trial processes within the pharmaceutical industry, preferably in the field of Cardiology
- Knowledge of GCP and regulatory requirements for the conduct of Cardiovascular clinical trials
- Ability to critically evaluate data, literature and presentations
- Ability to lead cross-functional teams