Medical Director - Partner Markets

Req #: 1803522
Location:Boudry, NeuchatelCH
Job Category:Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene Management SaRL
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary and Scope

To provide leadership and medical expertise in the development of strategic medical plans and clinical research programs in line with Celgene Global mid to long term strategy, regional priorities and local opportunities.

Keys Responsibilities

Hematology/Oncology Franchises

• Conduct strategic regional medical activities that will support the effective use and uptake of the Celgene portfolio, and accelerate and enhance global Celgene pipeline development


• Drive strategic plans for the development of clinical trials activities (both Clinical Development and Medical Affairs) according to Celgene pipe line, diseases landscape and business priorities


• Define country prioritization for medical activities in the International Markets that are aligned and integrated with global plans


• Build comprehensive understanding of institutional and KOL capabilities in the region and assess their ability to contribute to Celgene product development


• Provide medical input regionally and globally to cross-functional teams to ensure corporate understanding of medical needs in International Markets, as well as opportunities that exist


• Provide high level medical input into regulatory knowledge and strategy for countries in International Markets, with consequent strategic support to market access initiatives wherever possible

I&I Franchise

• Support I&I Medical Affairs leadership where no local I&I resource exists


• Provide guidance and support the selection and implementation of I&I R&D programs trials 


• Support and supervise specific regional activities where needed

Key Activities

A.Strategic Medical Affairs Projects

Regional KOL Management

• Help build database of KOLs in the region who have the ability to develop and contribute in a meaningful way to Celgene product development efforts


• Develop Celgene HCPs network through regional medical actions that balance the needs of key opinion leaders, health authorities and Celgene pipe line development


• Initiate with local teams and KOLs medical activities to generate epidemiologic data, increase disease landscape awareness and identify business opportunities


• Support local initiatives with the different national scientific societies and facilitate regional interactions and projects


• Help local KOLs to build international exposure throughout regional activities plan, publications projects, regional and international communications


• Initiate and drive young KOLs development programs

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Regional Medical Activities

• Collaborate with Partner Markets leadership team to ensure that medical activities are aligned with overall Celgene priorities and that cross-functional colleagues are fully informed of key medical initiatives


• Ensure prioritization of resource and financial commitments to countries in the region that are aligned with global needs


• Educate corporate colleagues regarding key opportunities and challenges in International Markets


• Provide assessment and understanding of clinical trial capabilities, and oversee a program of appropriately targeted clinical development and investigator-initiated trials in priority countries


• Define country-specific opportunities for clinical programs relating to endemic disease or specific areas of local expertise


• Encourage and initiate regional activities to develop interaction between different market stakeholders as scientific societies, national KOLs, international speakers and Celgene or partners


•  Acts as an expert and advisor for medical launch strategies, organization, interactions with HCPs


• Suggest, lead and support innovative medical activities to establish Celgene reputation, its development program and facilitate registration and access to new drugs in the different markets

Patient Access

• Identify and support educational patients and family programs through partnership with independent patient associations


• Improve collaboration with international association such International Myeloma foundation


• Strengthen Celgene commitment in patient advocacies programs


• Facilitate access to our medicines in countries in which Celgene has no presence through a global access program defined in terms of process, medical relevance, safety and cost.


• Management and oversight of pre-approval and compassionate use programs with Celgene products with full understanding of consequences and necessary compliance, monitoring and drug safety requirements


• Oversee continuity of drug supply chain to ensure no interruptions occur

Medical collaboration with Market Access and Regulatory

• Develop corporate expertise in regulatory needs for each country and implement efficient regulatory procedures where appropriate and in conjunction with global regulatory affairs


• Build understanding of market access opportunities in International markets and provide medical support to those initiatives


• Work closely with regulatory teams for the registration of new molecules in providing medical support, scientific strategic data and creating tailored medical documents such NIT (therapeutic notes) for registration dossiers


• Collaborate with market access teams to accelerate registration of new drugs and facilitate reimbursement and pricing   

Compliance

• Collaborate and support Global and European compliance team, providing insights into medical compliance issues and risks in International Markets  


• Participation and medical input into regional HCC reviews and ongoing needs


• Establish and ensure the strict application of Celgene SOPs and local guidelines for HCPs interactions as HCPs gifts, hospitality tools, invitation, honorariums, advisory boards.


• Oversee adherence to FMV processes and calculations


• Initiate and Implement process of promotional material validation

Safety and RMP

• Review, support and follow up the implementation of safety processes in International Markets region


• Initiate and supervise implementation of risk management plans in International Markets region

B. Clinical Research Development

Celgene international clinical trials

• Develop and implement plan to attract trials in the region and facilitate access for new drugs


• Attract selected trials according to local epidemiologic data, RD local competencies and business potential


• Interface with KOLs, RD teams and CROs


• Develop internal visibility and trust about EMEA Emergent markets RD competencies, recruitment potential, data reliability and business potential

Local IITs

• Facilitate and support local IITs initiative developed by local KOLs


• Coordinate internal process of approval and implementation

Regional and local trials initiatives

• Initiate medical affairs initiatives as observational studies, registries, publications

C. Celgene and partners medical teams coaching and team development

• Leverage on local competencies to buildstrategic synergies across the region


• Facilitate access to internal and external development programs


• Develop MSLs and medical advisor through specific trainings and coaching


• Seek out and leverage opportunities for sharing knowledge within the region and beyond

Skills and Knowledge Requirements

• Medical education or higher degree in related field coupled with extensive relevant experience


• Business oriented


• Strategically acting


• Innovative mindset


• Experienced clinical R& D and medical affairs


• Effective teamwork and teambuilding skills transferable across functional levels


• Leadership skills / negotiation skills


• Excellent oral / written / presentation – communications skills


• Cross functional and cross-cultural awareness


• Line management skills and expertise / mentoring and coaching


• Disease / therapeutic knowledge / expertise highly desirable


• Financial forecasting and budgeting skills & resourcing skills


• Time management - ability to effectively multi-task and prioritize in matrix environment


• Act strategically in developing short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals


• Willingness to travel


• Willingness to work at unusual times in different time zones


• Fluent in English. 


• French preferable

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