Medical Affairs Lead - Oncology-1418135W
Description
MISSION
- Provide medical expertise and contribute to the development/ growth of the products and portfolio, in line with the therapeutic area strategy, and in line with regulations.
- Contribute to the EMEA strategy and to the local Brand Plan
- Develop a Medical Education strategy and supervise its operational implementation
Develop, maintain and leverage relationships with thought leaders through the implementation of the KOL mapping and the management of clinical studies and ATU.
- Provide medical expertise to other Medical Affairs colleagues and to other internal stakeholders (marketing & sales, HEMAR, regulatory, training…)
- Take full responsibility for at least one product within the portfolio
- Direct line management of a team
MAIN ACTIVITIES
For the portfolio or for the product(s) if directly in charge :
Contribute to the EMEA medical strategy and to the local Brand Plan
- Articulate the medical voice within the CVT (Core Value Team) and represent the local voice at EMEA level within the Medical Affairs functional network, in particular during and after product launch.
- Provide medical input through :
- Management of local medical advisory boards
- Contacts with public institutions
- Analysis of protocols
- Knowledge of the literature
- Contribution to the local operational teams
Develop the KOL mapping as well as the relevant action plan as owner of this activity
- Develop the KOL mapping in collaboration with MSL, BI (Business Intelligence), RBM (Regional Business Manager) and any other relevant stakeholders
- Develop a KOL action plan and monitor its execution through the CVT
- Organise meeting to monitor execution and adapt if necessary
Contribute to the EMEA Medical Education strategy and develop the local Medical Education strategy
- Act as the local point of contact for the EMEA Medical Education team and ensure corelation between the IBVT (International Brand Value Team) strategy and the local tactical implementation
- Contribute proactively to the operations and activities led by EMEA
- Share best practices with the EMEA Medical Education team
- Leveraging on scientific and clinical expertise, develop a Medical Education strategy that fits the medical needs of the therapeutic area
Contribute to clinical research and data generation
- Define the budget and timetable for the studies to be run by GCO (Global Clinical Operations), act Study Responsible Physician (SRP)
- Ensure the overall follow up for EMEA/ Global studies put in place locally :
- Develop and maintain contacts with local investigators and centres
- Implement appropriate reporting (protocol updates, budget monitoring, recruitment…)
- Act as the interface with GCO
- Develop, implement and monitor clinical research activities initiated locally (eg. phase IV studies )
- Identify local centres with expertise in the therapeutic area and nominate as investigators for Janssen-sponsored studies
- Take part in the IIS review committees and submit local investigators’ IIS proposals in ReCAP as per the process in place
Monitor the "Autorisations Temporaires d'Utilisation"
- Ensure named-ATU and cohort-ATU are monitored appropriately
- Take responsibility for the medical validation of cohort-ATU requests according to the protocol for temporary use (PUT) in place
Provide support to the MSL team
- In collaboration with the Medical Director and the MSL Manager, develop the MSL communication strategy in line with the CVT strategy
- Adapt and implement the communication slide decks provided by the EMEA SKM team
- If needed, create novel communication material in collaboration with local medical experts
- Take part in the training of the MSLs
- Provide the MSLs with literature updates on the products and therapeutic area
Together with the Medical Director, ensure all MSL materials are appropriately validated
- Provide the MSLs with information on the activities taken based on the KOL mapping and action plan
Provide support to the sales force
- Provide training on products and therapeutic area
- Contribute to the development of and validate the promotional materials
Provide support to the Medisource team
- Provide training on products and therapeutic area
- Validate materials and documents (eg. Q&A)
Provide support to the Regulatory team and to the Safety team
- In the case of queries by the Authorities and for the follow-up of regulatory activities
Maintain scientific and medical expertise
- Review the literature on products and therapeutic area on a regular basis
- Interact with KOLs and experts in order to collect insights on products and therapeutic area
- Attend major congresses on therapeutic area
Team management
- Organize and evaluate the objectives and performance of direct reports
- Ensure a development plan is put in place for each direct report
- Foster team spirit and collaboration within the team as well as with transverse functions and support functions
- Promote the CREDO values internally and externally
MAIN STAKEHOLDERS
Internally
- EMEA functional network
- Medical Education manager
- MSLs and MSL Manager
- Medical Advisor
- GCO
- Other members of the medical department: Medisource, Safety, Regulatory
- Business Units: Marketing, Director of Promotion, Regional Business Manager, Sales Force
- Business Intelligence
- Market Access
Externally
- KOLs and other experts
- Cooperative Groups
- Medical Association
- Agencies providing services
Qualifications
Qualification
- A scientific / medical doctor degree is essential: Medical Doctor (MD), PharmD, PhD
- Additional training in business or administration management would be a plus
Experience
- Minimum 5 year experience in the pharmaceutical industry + a positive managerial experience
- An additional field-based or customer-facing experience: MSL, Medical Education manager would be a plus
Key skills and attributes
- Ability to searche, analyse and synthetize complex scientific and medical information from multiple data sources
- Excellent written and oral communication skills in English
- Medical and scientific expertise, ideally in oncology
- Ability to develop a strategic vision and therefore to anticipate changes within the therapeutic area
- Ability to lead complex project and to multi-task
- Excellent communication skills, public speaking, negociating and influencing skills in an impactful and soft way
- Humble mindset to accept feedback, collaborative mindset
- “Out of the box thinking”, ability to promote change and innovation
- Team player with the ability to federate a direct reports team and have a collaborative influence transversally
Primary Location:Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux
Organization: Janssen Cilag S.A.S. (7825)
Job Function: Medical Affairs
Description
MISSION
- Provide medical expertise and contribute to the development/ growth of the products and portfolio, in line with the therapeutic area strategy, and in line with regulations.
- Contribute to the EMEA strategy and to the local Brand Plan
- Develop a Medical Education strategy and supervise its operational implementation
Develop, maintain and leverage relationships with thought leaders through the implementation of the KOL mapping and the management of clinical studies and ATU.
- Provide medical expertise to other Medical Affairs colleagues and to other internal stakeholders (marketing & sales, HEMAR, regulatory, training…)
- Take full responsibility for at least one product within the portfolio
- Direct line management of a team
MAIN ACTIVITIES
For the portfolio or for the product(s) if directly in charge :
Contribute to the EMEA medical strategy and to the local Brand Plan
- Articulate the medical voice within the CVT (Core Value Team) and represent the local voice at EMEA level within the Medical Affairs functional network, in particular during and after product launch.
- Provide medical input through :
- Management of local medical advisory boards
- Contacts with public institutions
- Analysis of protocols
- Knowledge of the literature
- Contribution to the local operational teams
Develop the KOL mapping as well as the relevant action plan as owner of this activity
- Develop the KOL mapping in collaboration with MSL, BI (Business Intelligence), RBM (Regional Business Manager) and any other relevant stakeholders
- Develop a KOL action plan and monitor its execution through the CVT
- Organise meeting to monitor execution and adapt if necessary
Contribute to the EMEA Medical Education strategy and develop the local Medical Education strategy
- Act as the local point of contact for the EMEA Medical Education team and ensure corelation between the IBVT (International Brand Value Team) strategy and the local tactical implementation
- Contribute proactively to the operations and activities led by EMEA
- Share best practices with the EMEA Medical Education team
- Leveraging on scientific and clinical expertise, develop a Medical Education strategy that fits the medical needs of the therapeutic area
Contribute to clinical research and data generation
- Define the budget and timetable for the studies to be run by GCO (Global Clinical Operations), act Study Responsible Physician (SRP)
- Ensure the overall follow up for EMEA/ Global studies put in place locally :
- Develop and maintain contacts with local investigators and centres
- Implement appropriate reporting (protocol updates, budget monitoring, recruitment…)
- Act as the interface with GCO
- Develop, implement and monitor clinical research activities initiated locally (eg. phase IV studies )
- Identify local centres with expertise in the therapeutic area and nominate as investigators for Janssen-sponsored studies
- Take part in the IIS review committees and submit local investigators’ IIS proposals in ReCAP as per the process in place
Monitor the "Autorisations Temporaires d'Utilisation"
- Ensure named-ATU and cohort-ATU are monitored appropriately
- Take responsibility for the medical validation of cohort-ATU requests according to the protocol for temporary use (PUT) in place
Provide support to the MSL team
- In collaboration with the Medical Director and the MSL Manager, develop the MSL communication strategy in line with the CVT strategy
- Adapt and implement the communication slide decks provided by the EMEA SKM team
- If needed, create novel communication material in collaboration with local medical experts
- Take part in the training of the MSLs
- Provide the MSLs with literature updates on the products and therapeutic area
Together with the Medical Director, ensure all MSL materials are appropriately validated
- Provide the MSLs with information on the activities taken based on the KOL mapping and action plan
Provide support to the sales force
- Provide training on products and therapeutic area
- Contribute to the development of and validate the promotional materials
Provide support to the Medisource team
- Provide training on products and therapeutic area
- Validate materials and documents (eg. Q&A)
Provide support to the Regulatory team and to the Safety team
- In the case of queries by the Authorities and for the follow-up of regulatory activities
Maintain scientific and medical expertise
- Review the literature on products and therapeutic area on a regular basis
- Interact with KOLs and experts in order to collect insights on products and therapeutic area
- Attend major congresses on therapeutic area
Team management
- Organize and evaluate the objectives and performance of direct reports
- Ensure a development plan is put in place for each direct report
- Foster team spirit and collaboration within the team as well as with transverse functions and support functions
- Promote the CREDO values internally and externally
MAIN STAKEHOLDERS
Internally
- EMEA functional network
- Medical Education manager
- MSLs and MSL Manager
- Medical Advisor
- GCO
- Other members of the medical department: Medisource, Safety, Regulatory
- Business Units: Marketing, Director of Promotion, Regional Business Manager, Sales Force
- Business Intelligence
- Market Access
Externally
- KOLs and other experts
- Cooperative Groups
- Medical Association
- Agencies providing services
Qualifications
Qualification
- A scientific / medical doctor degree is essential: Medical Doctor (MD), PharmD, PhD
- Additional training in business or administration management would be a plus
Experience
- Minimum 5 year experience in the pharmaceutical industry + a positive managerial experience
- An additional field-based or customer-facing experience: MSL, Medical Education manager would be a plus
Key skills and attributes
- Ability to searche, analyse and synthetize complex scientific and medical information from multiple data sources
- Excellent written and oral communication skills in English
- Medical and scientific expertise, ideally in oncology
- Ability to develop a strategic vision and therefore to anticipate changes within the therapeutic area
- Ability to lead complex project and to multi-task
- Excellent communication skills, public speaking, negociating and influencing skills in an impactful and soft way
- Humble mindset to accept feedback, collaborative mindset
- “Out of the box thinking”, ability to promote change and innovation
- Team player with the ability to federate a direct reports team and have a collaborative influence transversally
Primary Location:Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux
Organization: Janssen Cilag S.A.S. (7825)
Job Function: Medical Affairs