メディカル・バイオ - 前臨床（薬効薬理・毒性・ADME）

【Summary】
TME-Japan Level 5-6 Provide medical and scientific expertise and leadership to: 1. Drive success of early global programs, develop and implement strategies to achieve clinical Proof of Concept (PoC) 2. Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profil-ing packages that meet regulatory requirements and support differentiated and competi-tive drug labeling 3. Support Translational Research in developing new indications, endpoints and bi-omarkers, using in vitro, in vivo, or in silico methods 4. Provide scientific expert assessments and support for in-licensing opportunities, in-cluding due diligences Note: A TME may do some or all of these or alternate among them, as program needs dictate

【About the Role】
Provide medical and scientific expertise and leadership to:

1. Drive success of early global programs, develop and implement strategies to achieve clinical Proof of Concept (PoC)

2. Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling

3. Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods

4. Provide scientific expert assessments and support for in-licensing opportunities, including due diligences

Note: A TME may do some or all of these or alternate among them, as program needs dictate

■ASSOCIATE DIRECTOR
• Able to run a clinical trial with satisfactory clinical and safety review, ability to manage study-level issues.
• Needs assistance and oversight from more experienced TMDP colleagues to evaluate strategic questions for programs and to evaluate the impact of study-level decisions on clinical development plans.
• Able to conceive, obtain approval, and oversee TR or data science studies in collaboration with other line functions.
• Subject matter expert for team and potentially beyond, to TA and DA.
• Able to bring cutting edge medical and scientific knowledge to teams in BR and Development.
• Able to present TM plans to decision boards in DA and TED, and externally as appropriate.

■DIRECTOR
• Able to run more than one clinical trial independently.
• Able to manage most TM aspects of a clinical development program with review by more experienced TMDP colleagues.
• Able to develop drug project strategy from earliest aspects of TR through clinical development.
• Subject matter expert for TM, BR, and Development.
• Able to influence program strategy for TM aspects of development programs inI BR and Development.
• Able to represent TM at Novartis decision boards, and externally as appropriate.

■休日：完全週休二日制

■Education (minimum/desirable):
Doctoral degree, MD required in most cases.
Demonstrated excellence and clinical expertise in relevant medical subspecialty.

■Languages:
Fluent English (oral and written). For Japan, Fluent Japanese (oral and written)

■Experience/Professional Requirement:
• At least 2 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience. Additional experience may be required at higher levels.
• Recognized medical expertise, as evinced by publication of significant contributions to a field over time.
• Excellent written and oral communication/presentation skills.
• Independence: Able to work independently as outlined above, commensurate with level of role.
• Innovation: Seeks out new clinical discovery opportunities and PoC approaches.
• Demonstrated passion for science
• Recognized expert in field, driving success for individual studies and projects; respected by colleagues across R&D, Development, and externally.

■職種未経験者：不可