Chief Medical Officer (CMO) - Therapeutic (NHL) - San Diego, CA | Biospace
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Chief Medical Officer (CMO) - Therapeutic (NHL)

HUYA Bioscience International

Location:
San Diego, CA
Posted Date:
7/27/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Come join our world-class team evaluating, in-licensing and developing innovative therapeutic products internationally.

HUYA Bioscience International is a biopharmaceutical company focused on globalizing products from China and Asia for the world markets in multiple therapeutic areas. The Company’s lead compound in oncology, HBI-8000, is already approved for lymphoma in China, and is in late stage clinical development in Japan and Korea.  In the United States, the compound is being developed in immuno-oncology. HUYA also has two other compounds for cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

HUYA is seeking a highly motivated Chief Medical Officer to join our dynamic organization. You will report directly to the President. The primary role of the CMO will be to provide leadership and direction for HUYA’s pipeline of clinical development programs primarily in immune-oncology. The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans that meet the strategic directives for the organization. The CMO will be a key member of the company’s Executive Committee which helps determine and manage research and drug development. The CMO should serve as an internal thought leader and be respected within the clinical community, capable of describing the Company’s products and development programs externally.

This is an office based position that works in a cross-functional and dynamic environment.  Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.  

Primary Duties and Responsibilities

•   Direct the development of clinical strategies and plans to integrate HUYA’s compounds into the standard practice of oncology.
•   Manage clinical aspects of regulatory strategies and interactions with Health Authorities
•   Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
•   Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders. Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
•   Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
•   In addition to leading and supervising the Clinical Research Department, the CMO will have direct line responsibility for the Clinical Operations and Regulatory Affairs.
•   Meet the QA compliance obligations according to guidelines.

Requirements

•   Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
•   Excellent knowledge of the competitive environment for drugs in the Oncology marketplace and in research and development pipelines
•   Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
•   The successful candidate must possess excellent communication skills and be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community.
•   Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
•   Must be science- and data-driven
•   For best fit, the candidate must have the ability and strong desire to “make things happen”.
•   Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”.
•   Must have the highest personal values and ethical standards.
   
Education and Experience

•   MD with Board Certification in Oncology with training preferred
•   15 years+ experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
•   Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations
•   Experience with, or strong knowledge of Oncology drug development
•   Experience in translational medicine, clinical pharmacology and early stage development is desirable
•   A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)