Regional Therapeutic Area Expert - Asia Pacific (4 positions)-00000E4R
Description
Regional Therapeutic Area Expert - Asia Pacific
Janssen Research & Development, LLC, a member of the J&J Family of Companies is recruiting for a Regional Therapeutic Area Expert (RTAE) to be located in the Asia Pacific region.
The Regional Therapeutic Area Expert (RTAE) is accountable for establishing a Therapeutic Area (TA) strategy for the region balancing various stakeholder requirements (TA, R&D and MAF, local operating company and external partners (KOL, academic centers …)) with the need to find high quality investigational sites and pools of patients to optimize trial execution in the region.
The RTAE has an operational accountability by providing overall direction for successful trial execution (short term as well as longer term focus); providing input to optimize protocol design for successful trial execution (do-ability) and proposes the country and site selection strategy for the region (feasibility) as well as follow up on regional trial performance and proposing/initiation of mitigation steps if needed. To fulfill its strategic and operational responsibility the RTAE is expected to have a thorough knowledge of the TA landscape in the region and have excellent networking capabilities.
Four RTAEs will be appointed in each region (US, Canada, LATAM, APAC): one for Immunology, one for Oncology, one for Infectious diseases & Virology and one for Neuroscience and Cardiovascular/Metabolism combined. The RTAE resides in the GCO regional organization and has a dual reporting line: one to the regional head (functional manager) and one to the COH in the GCO central trial organization. The RTAE will build a strong partnership with: internal stakeholders: TA team, COH, CPL and GTMs, Global Enrolment Strategy group, country based therapeutic area experts (GCO country heads, CRM or senior LTM specialized in a TA), local MAF or commercial teams (Integrated/local Brand Value teams) external partners by engaging directly in peer to peer contacts with KOL, academic centers, preferred investigational sites in the various countries in the region.
Roles & Responsibilities:
Has a thorough knowledge of the TA landscape in the region:
- Collaborates with the study placement group and the local organizations to validate/update epidemiologic data gathered centrally;
- Collaborates with the Global Enrollment Strategy (GES) group and local organizations to validate/update regional TA Expertise/intelligence database (country categorization, top recruiters,);
- Has a good in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment …);
- Able to engage directly in peer to peer contacts and build and maintain strong partnerships with investigators, KOLs, investigational sites, local experts, academic groups in the different countries of the region;
- Has a good understanding of the standard of care in the region, the different health care systems and is able to assess potential impact on TA programs, reference drugs and is able to advise central teams and TA on the future strategy for the region.
Contributes to develop the region
- Support/promote: quality improvements for the region, patient recruitment/retention strategies, identify key contributing factors for the success of countries, lessons learned exercises for poor performance and share success among the countries in the region, Support the central and local teams in ensuring good training on pathology and protocol, Find and develop new investigational sites as required by TA and future clinical trial demands (pro-active approach to longer term/future trial pipeline) in order to maximize on country and regional performance in clinical trials
Do-abilities and Feasibilities
- Provide central teams (CPL) and TA with consolidated input from the regions on protocol proposals/outlines (do-ability) and identify factors for successful recruitment and country selection (scenario building).
- Provide regional/country input in the feasibility questionnaire to the GTM before finalizing the feasibility questionnaire to ensure optimal country and site selection for successful trial execution (start up, recruitment and quality).
- Work with the GTM to define a consolidated proposal of country and site selection balancing maximizing on the true potential of a country, recruitment potential and speed and quality. Define back up strategy.
- Will be held accountable for all agreed qualitative/quantitative metrics for the region in agreement with global stakeholders
Qualifications
Qualifications:
- A Master’s degree with specific specialization with a strong preference for an MD/PhD.
- Preferentially a minimum of 6 years of experience with clinical research and strong experience with the TA within the region.
- Proficiency in writing and speaking of English is required; multilingual skills are an advantage.
- Good scientific and medical expertise enabling peer-to-peer connections with KOLs and broad experience in the pharmaceutical industry and drug development process is required.
- Good knowledge and understanding of Janssen R&D in general and CDO/GCO in particular.
- Solid knowledge of ICH-GCP, GCO SOPs and relevant local regulations related to clinical research.
- Must be 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 leadership is required
- Internal 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 is required
- Must have strong problem solving ability; Pro-active mindset and attitude; Strategic thinking;
- Ability to work in an international and diverse environment, with good cultural sensitivity;
- Big picture orientation with attention to details;
- Able to identify opportunities for improvement and drive innovation in the region and in GCO organization as a whole
- Up to 30 % travel
LOCATION
This position is to be based in APAC, successful candidate will remain in their current country of residence (in the APAC region) No relocation support will be provided.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Other Locations:Asia Pacific
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Clinical Trial Administration
Description
Regional Therapeutic Area Expert - Asia Pacific
Janssen Research & Development, LLC, a member of the J&J Family of Companies is recruiting for a Regional Therapeutic Area Expert (RTAE) to be located in the Asia Pacific region.
The Regional Therapeutic Area Expert (RTAE) is accountable for establishing a Therapeutic Area (TA) strategy for the region balancing various stakeholder requirements (TA, R&D and MAF, local operating company and external partners (KOL, academic centers …)) with the need to find high quality investigational sites and pools of patients to optimize trial execution in the region.
The RTAE has an operational accountability by providing overall direction for successful trial execution (short term as well as longer term focus); providing input to optimize protocol design for successful trial execution (do-ability) and proposes the country and site selection strategy for the region (feasibility) as well as follow up on regional trial performance and proposing/initiation of mitigation steps if needed. To fulfill its strategic and operational responsibility the RTAE is expected to have a thorough knowledge of the TA landscape in the region and have excellent networking capabilities.
Four RTAEs will be appointed in each region (US, Canada, LATAM, APAC): one for Immunology, one for Oncology, one for Infectious diseases & Virology and one for Neuroscience and Cardiovascular/Metabolism combined. The RTAE resides in the GCO regional organization and has a dual reporting line: one to the regional head (functional manager) and one to the COH in the GCO central trial organization. The RTAE will build a strong partnership with: internal stakeholders: TA team, COH, CPL and GTMs, Global Enrolment Strategy group, country based therapeutic area experts (GCO country heads, CRM or senior LTM specialized in a TA), local MAF or commercial teams (Integrated/local Brand Value teams) external partners by engaging directly in peer to peer contacts with KOL, academic centers, preferred investigational sites in the various countries in the region.
Roles & Responsibilities:
Has a thorough knowledge of the TA landscape in the region:
- Collaborates with the study placement group and the local organizations to validate/update epidemiologic data gathered centrally;
- Collaborates with the Global Enrollment Strategy (GES) group and local organizations to validate/update regional TA Expertise/intelligence database (country categorization, top recruiters,);
- Has a good in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment …);
- Able to engage directly in peer to peer contacts and build and maintain strong partnerships with investigators, KOLs, investigational sites, local experts, academic groups in the different countries of the region;
- Has a good understanding of the standard of care in the region, the different health care systems and is able to assess potential impact on TA programs, reference drugs and is able to advise central teams and TA on the future strategy for the region.
Contributes to develop the region
- Support/promote: quality improvements for the region, patient recruitment/retention strategies, identify key contributing factors for the success of countries, lessons learned exercises for poor performance and share success among the countries in the region, Support the central and local teams in ensuring good training on pathology and protocol, Find and develop new investigational sites as required by TA and future clinical trial demands (pro-active approach to longer term/future trial pipeline) in order to maximize on country and regional performance in clinical trials
Do-abilities and Feasibilities
- Provide central teams (CPL) and TA with consolidated input from the regions on protocol proposals/outlines (do-ability) and identify factors for successful recruitment and country selection (scenario building).
- Provide regional/country input in the feasibility questionnaire to the GTM before finalizing the feasibility questionnaire to ensure optimal country and site selection for successful trial execution (start up, recruitment and quality).
- Work with the GTM to define a consolidated proposal of country and site selection balancing maximizing on the true potential of a country, recruitment potential and speed and quality. Define back up strategy.
- Will be held accountable for all agreed qualitative/quantitative metrics for the region in agreement with global stakeholders
Qualifications
Qualifications:
- A Master’s degree with specific specialization with a strong preference for an MD/PhD.
- Preferentially a minimum of 6 years of experience with clinical research and strong experience with the TA within the region.
- Proficiency in writing and speaking of English is required; multilingual skills are an advantage.
- Good scientific and medical expertise enabling peer-to-peer connections with KOLs and broad experience in the pharmaceutical industry and drug development process is required.
- Good knowledge and understanding of Janssen R&D in general and CDO/GCO in particular.
- Solid knowledge of ICH-GCP, GCO SOPs and relevant local regulations related to clinical research.
- Must be 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 leadership is required
- Internal 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 is required
- Must have strong problem solving ability; Pro-active mindset and attitude; Strategic thinking;
- Ability to work in an international and diverse environment, with good cultural sensitivity;
- Big picture orientation with attention to details;
- Able to identify opportunities for improvement and drive innovation in the region and in GCO organization as a whole
- Up to 30 % travel
LOCATION
This position is to be based in APAC, successful candidate will remain in their current country of residence (in the APAC region) No relocation support will be provided.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Other Locations:Asia Pacific
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Clinical Trial Administration