Medical Manager/Director
Responsibility:

1. Maintain scientific and clinical knowledge in the specific therapeutic and disease areas

2.   Contribute to the clinical development strategy for the relevant therapeutic/disease areas

3.   Conduct literature searches and analyze the data and information necessary to create the clinical development plan

4.   Take medical responsibilities for clinical trials:

4.1 Develop clinical study design for internal reviews

4.2  Provide support to clinical operation and other groups to develop Informed Consent Form (ICF), Case Report Form (CRF), CRF instructions, etc

4.3 Review and/or write additional clinical science documentation and/or provide clinical science input into other  documentation managed by other groups

4.4 Collaborate with data management and other groups to conduct medical review of study data, identify and evaluate the data outliers and query the sites

4.5 Collaborate clinical operation and other groups to identify and evaluate the protocol deviations

4.6 Review the study report and respond to authority’s inquiries

4.7 Prepare or review abstracts, posters, and content for scientific events etc.

4.8 Collaborate with regulatory and other team to complete and submit regulatory filings and other regulatory documentation.

5.  Collaborate with PV to review safety data and provide medical support and judgement to ensure the high standards of clinical safety

6.  Provide medical support to Commercial, Market Access, Regulatory, Pharmacovigilance, and Legal Counsel

7.  Provide initial and ongoing medical trainings to MSLs and commercial team and in collaboration with MSL to provide training to external staff

8.  Review training documents and other promotional or non-promotional materials to ensure medical accuracy and compliance with regulatory requirements

Requirements:

1.  Masters Degree at least in life sciences required. The experience in oncology, hematology or with a broad medical background is preferred

2.  Minimal 3 years in clinical practice, pharmaceutical medical affairs or clinical development

3.  Able to work within matrix organization and provide leadership

4.  Design and implement clinical trials

5.  Disease area knowledge, including key scientific publications

6.  Well-versed in medical aspects of GCP, ICH, CFDA

7.  Good scientific thinking, agility in learning and good communication skills


Recruitment:1
Contact us:
human_resources@fosunkitebio.com