Regional Therapeutic Area Expert Asia Pacific Director - 上海市 - Johnson Family Companies
- Regional Therapeutic Area Expert Asia Pacific Director
- Johnson Family Companies
- 上海市 C23
- 19 Jun, 2017 4 days ago
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POSITION TITLE: Regional Therapeutic Area Expert (RTAE) PRINCIPAL RESPONSIBILITIES:
List major responsibilities and duties of the position. List most complex or difficult parts of job first. Describe scope of responsibilities.
1) Define strategy, develop the region (based on portfolio planning) to ensure successful and efficient trial allocation /execution
Provide early input in protocol design from the region to optimize trial execution (recruitment, timelines, quality)
Develop regional strategy and support the countries in building strategic relationships with network of investigators
Support finding new investigational sites, as required by TA/MAF and future clinical trial demands
Build an appropriate knowledge base to execute future programs With central team, support good training on pathology and protocol for local teams
Provide regional input/represent the region in meetings and discussions on study placement / allocations (e.g. core review team meetings, working group meetings, scientific and operational review meetings, feasibility review meetings)
2) Operational Responsibilities
Provide PDO and TA/MAF consolidated regional input and identify elements for successful recruitment and country selection
Obtain consolidated country /regional input during protocol feasibility and provide proposal for list of countries from the region for site feasibility
Work with RTAEs from other regions to develop global recommendations for protocol and study placement.
Help design critical feasibility questions to ensure successful trial execution (recruitment and quality)
Define regional commitment at the time of conduct of site feasibility and be accountable for consolidated proposal of country and site selection based on feasibility outcome for the region and applying regional efficiency criteria (regulatory and market access requirements, start up timelines, recruitment speed, productivity and quality)
Support PDO in building up and implementing recruitment contingency for the region in an assigned study
Support delivery of trial performance through mitigation activities as directed within the region.
Share accountability with GCO Regional Heads for delivery of country enrollment commitments
Participate in Portfolio Review meetings for the trial/region
3) Has a thorough knowledge of the TA landscape in the region
Has a good in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment etc.).
Has a good understanding of the standard of care in the region, the different health care systems and relevant local regulations, is able to assess potential impact on TA programs, reference drugs and is able to advise PDO teams and TA on the future strategy for the region. 4) Establish strong and productive relationship with PDO, the countries within the region and relavant non-GCO stakeholders e.g., MAF; and Commercial, Regulatory, Project Management Office (PMO) as required. PRINCIPAL RELATIONSHIPS:
Describe the primary working relationships (internal & external) and primary interfaces. Contacts inside the company may include:
Global Program Lead (GPLs), GOHs, GTLs, GCO Country Managers/Heads, Clinical Research Manager (CRM)/Functional Manager (FM), Local Trial Manager (LTM), Site Manager (SM),Study Placement & Analytics (SPA), Therapeutic Area functions and Clinical Team members, MAF and Commercial teams (as required).
Contacts outside the company may include: Investigatational Sites, Key Opinion Leader (KOLs), Adboard Members, Patient Engagement Groups, Academic Centers, vendors with focus on study placement, recruitment & retention capabilities.
EDUCATION AND EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
Significant experience in the specific TA area assigned. MD/Phd will be advantageous
Preferentially more than 6 years of experience with clinical research and strong experience with the TA within the region
Based in one of the countries of the GCO region
Proficiency in writing and speaking of English; multilingual skills is an advantage
Experience of successfully working a heavily matrixed organization. Able to lead and influence without direct authority.
Comfortable with ambiguity. Deals well with shaping direction in a new area, and building a new organization with limited guidance. Challenges status quo. Understands and where needed adapts to different cultures and markets.
Advanced communication and presentation skills required.
Exceptional networker. Connects easily and broadly across the organization and across countries. Is effective in working in a virtual global organization.
Good scientific and medical expertise enabling peer-to-peer connections with KOLs
Broad experience in the pharmaceutical industry and drug development process
Good knowledge and understanding of Janssen R&D in general and PDO/GCDO in particular
Solid knowledge of ICH-GCP, GCDO SOPs and relevant local regulations related to clinical research.
Capable of providing TA, compound and protocol training within the region as necessary (lead local Investigator meetings if needed)
Excellent interpersonal skills and ability to demonstrate leadershipInternal and external partnering; ability to build relationships across the business and externally; ability to influence clinical research strategies to ensure successful execution of current and future clinical trials
Strong problem solving ability
Pro-active mindset and attitude
Able to identify opportunities for improvement and drive innovation in the region and in GCO organization as a whole
Ability to work in an international and diverse environment, with good cultural sensitivity
Big picture orientation with attention to details
Willingness to travel regionally/globally
Please note that there is no relocation assistance provision for this position.
The selected candidate can continue to be based in his or her home country which can be in either Singapore, Malaysia, Taiwan, Korea, China (Shanghai or Beijing), Australia or India.
Asia Pacific-South Korea, Asia Pacific-India-Maharashtra-Greater Mumbai, Asia Pacific-China-Shanghai-Shanghai, Asia Pacific-Taiwan-Taipei-Taipei, Asia Pacific-Australia-New South Wales-Sydney, Asia Pacific-Malaysia-Kuala Lumpur-Kuala Lumpur
Johnson & Johnson Pte. Ltd. (8435)
Clinical Research non-MD