Chief Medical Officer

Report to: CEO

 

Job Purpose:


A key member of CANbridge’s executive team with responsibilities for overseeing the development of the company’s global product portfolio strategy to bring products, services and programs to market in compliance with Chinese and global regulatory, medical and quality requirements. This role has a functional responsibility for all clinical development activities, which include Phase I through Phase IV programs and will also have responsibility for on-market products.

 

Responsible for developing and implementing strategic and tactical plans for clinical-stage oncology development programs to meet global and Chinese quality and safety standards with an emphasis on leveraging the synergies and complementary features of the regulatory framework, disease profile and standard of care between China and the Western countries. This leader also has the responsibility for all aspects of clinical development, including providing leadership and oversight to clinical development, medical affairs, pharmaco-vigilance, regulatory affairs, biostatistics and data management to ensure a successful product approval and launch. 

 

He/she will oversee company’s clinical stage portfolio management activities to ensure appropriate organization, system and resources are deployed for delivery of key clinical milestones in collaboration with the Head of Preclinical Development, Head of CMC and his/her CRO counterparts. In addition, he/she will be responsible for representing the company with regulatory and legislative agencies and KOL communities globally addressing the scientific and medical/health aspects of the company’s product portfolio.

 

He/She will also work closely with the CEO in representing the company with investors, analysts, and existing and potential partners and collaborators. Furthermore, he/she will play a critical role in participating in the due diligence review of new opportunities.

 

Responsibilities:


Provide clinical development leadership and guidance in clinical trial feasibility assessment, the design of multiregional clinical trial (MRCT) and in-country clinical protocols and investigator recruitment with an emphasis on safety, medical and regulatory compliance and quality. Oversees the analysis and interpretation of clinical trial data and preparation of Clinical Study Reports (CSR).

Represent the company in building and managing peer-to-peer clinical development partnerships with US and EU based biopharmaceutical companies by leading the planning and execution with CANbridge’s counterparts of mutually agreeable global and regional clinical development plan.

Represent the company to lead Interactions with CFDA, FDA and other regulatory authorities in preparation of IND filing, safety reports and NDA filings; Manage and contribute medical input and review of regulatory documents such as IND filings, clinical reports and NDAs.

Provide leadership and management in designing and building CANbridge in-house and outside medical and clinical development organization and capabilities to meet the company’s product portfolio strategy and development need and compliance requirement. Oversees the company’s product portfolio clinical investments to meet fiscal year goals and key milestones, providing strategic input to the annual and long-range budgetary process.

Provide medical, clinical and feasibility assessment to CEO and company business development team on prospective in-licensing and co-development opportunities.

Provide medical and clinical expertise, oversight and management, including but not limited to medical training for clinical operations, KOLs and study staff, and medical reports and reviews of data collection forms.

Engage Chinese and global KOLs and Chinese and global regulators in treatment guideline discussions.

Ensures that the appropriate amount of monitoring is in place to support clinical trials, ensuring and monitoring the safety of enrolled subjects.

Represent the company with investors and participate in company roadshows and key investor conferences.

Meet scientific/medical objectives and keep abreast of current medical/scientific progress, actively developing and maintaining relationships with outside experts.

Comply with all applicable policies regarding Health, Safety and Environment.

 

 

Academic / Professional qualification

A MD degree is required.

A minimum of fifteen years clinical development and/or practicing physician experience.

Experience with and strong knowledge of Oncology drug development 

Knowledge of relevant CFDA, 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 CFDA is highly preferred.


Working experience:

Experience in managing global clinical trials or multi-regional clinical trials (MRCT) that involving China or China-based clinical trials.

Experience in interaction with FDA and CFDA.

Experience in clinical development of large molecule drug candidates.

Excellent leadership, organization, judgment, decision making, coordination, influence and excellent team management skills.

A proven track record in Phase I- III 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).

Built, managed and leveraged in-house and external CRO’s cross-functional collaborative relationships to achieve major company development milestones highly desirable.

 

Language ability: 

Fluent in English, fluent in oral Mandarin highly desirable.  

 

Location:

Shanghai.

Ability to travel up to 30% of time.

 

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