The CMO is a key member of our client'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 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.
The CMO will be responsible for developing and implementing strategic and tactical plans for clinical-stage oncology development programs to meet global 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 Western countries and China. This leader also has the responsibility for all aspects of clinical development, including providing leadership and oversight to clinical development, medical affairs, pharmacovigilance, 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.
A MD degree is required with a minimum of fifteen years clinical development and/or practicing physician experience. One should have experience with and strong knowledge of Oncology drug development and 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 with FDA and CFDA interactions and experience in clinical development of large molecule drug candidates. 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). Experience building, managing and leveraging in-house and external CRO's cross- functional collaborative relationships to achieve major company development milestones highly desirable
For additional information, contact Jackie Bandish at 267-483-5233 x 104 or firstname.lastname@example.org.