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[±¹³»À¯¸Áº¥Ã³±â¾÷] Medical Director ÀÓ¿ø±Þ ¸ðÁý
¢Ã Position : [±¹³»À¯¸Áº¥Ã³±â¾÷] Medical Director ÀÓ¿ø±Þ ¸ðÁý
1. ¸ðÁý¿ä°
Key Accountabilities
1. Clinical Development
o Be accountable that TPP/CDP is aligned with medical/scientific rationale and company
strategies
o Be accountable for clinical documents are written according to the available
safety/efficacy information, sufficient scientific/medical rationale, SOPs, ICH-GCP and
any applicable regulations. The clinical documents include but not limited to the clinical
protocol/ synopsis, informed consent form, Investigator¡¯s Brochures, CRF, SAP, CSR
and any regulatory approval submission documents.
o Support clinical operational team by attending any regular team call, Investigator
Meeting or official investigator visits.
o Interact/communicate with clinical investigators/investigative sites in regard to any
medical related questions, e.g., subject enrollment criteria, protocol deviations, or drug
safety, dose modifications.
2. Safety
o Ensure drug safety and surveillance activities are consistent with product safety
information, SOPs, applicable regulations and ICH guidelines.
o Provide medical review of any SAE related reports and work with a Safety team to
resolve queries.
o Verify the medical accuracy of patient safety data and maintain an ongoing assessment
of the safety profile of ImmunOncia products and clinical protocols
o Review and provide inputs to any product safety documents, e.g., DSUR
3 Medical Support
o Build and maintain key opinion leader relationships consistent with development
objectives
o Review, interpret and present clinical data from development program and the relevant
literature at relevant scientific meetings.
o Author/Co-author any publication related to company products or clinical programs
o Demonstrate substantial and relevant knowledge of scientific and medical literature and
its application to strategic design of the product development.
3. Other
o Provide expert opinion and due diligence research on business development
opportunities
o Contribute medical input to any other relevant clinical and scientific activities
o Provide any therapeutic area training to the company internal team as necessary
Skills
- Scientific and analytic ability, ability to think strategically and tactically, an interest in applied
clinical research, an ability to work effectively in multifunctional teams and excellent
organizational and communication skills.
- Strong computer and internet skills including knowledge of MS-Office products such as Excel,
Word.
- Strong regulatory knowledge including ICH guidelines.
Background and Qualification
- Medical Degree with board certified preferred
Language Skills
- Competent in written and oral English and fluent in Korean
Minimum Work Experience
- 5+ years in relevant functions in the pharmaceutical industry, or equivalent
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À̸ÞÀÏ : jhkwak@jhhr.co.kr
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