Medical Operations Manager - Partner Markets

Req #: 1804037
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

To oversee and execute medical operational activities in Partner Markets, whilst providing support to the development of strategic medical plan and clinical research programs in line with Celgene Global mid long term strategy, regional priorities and local opportunities.

Role and Responsibilities

Across both franchises: ensure all medical activities are conducted in full compliance with Celgene and other regulations, provide support to regulatory and market access efforts, manage Drug Safety and RMP needs, and conduct appropriate scientific and medical education according to Celgene best practices.

Hematology/Oncology Franchises

• Execute regional medical activities driven by KOLs that enhance a long-term partnership and Celgene pipeline development


• Support  the development of targeted clinical trials that enhance progress with the Celgene pipe line, address local data generation needs, build knowledge of diseases landscape, and help define business priorities


• Provide medical support to the different partner teams to accelerate access to the new drugs through efficient registration and market access processes


• Initiate and supervise KOLs development plan

I&I Franchise

• Support the I&I Medical Affairs team in their operations in these markets


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


• Support and supervise specific regional activities

Key Activities

A. Medical Affairs Projects

Support Medical Director Partner Markets in execution of Strategic Medical Affairs projects across the region, specifically:

Regional KOLs Management

• 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 through regional activities plan, publications, clinical projects, regional and international communications


• Initiate and drive young KOLs development programs

                    

Regional Medical Activities

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


• Support local HCPs in medical launch activities and other projects with Celgene 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 programs for patients and families through partnership with independent patient associations


• Improve collaboration with international disease associations such as International Myeloma Foundation


• Strengthen Celgene commitment in patient advocacy programs


• Help define and facilitate access to our medicines in countries in which Celgene has no presence through appropriate access programs that are clearly defined in terms of process, medical need, safety and cost.


•  Oversee the execution and monitoring of pre-approval access programs to ease access to unregistered drugs or for off-label use based on patient need, local standard of care, strict medical monitoring, safety and rigorous RMP


• Support Medical Director in ensuring drug supply chain is well-managed and continuity of patient drug supply is assured

Medical collaboration with Market Access and Regulatory

• Support Medical Director Partner Markets and relevant regulatory teams towards the registration of new molecules by providing medical support, scientific strategic data and helping create tailored medical documents such as NIT (therapeutic notes) for registration dossiers


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

Compliance

• Collaborate and support Global and European compliance team


• Identify compliance risk within Partner Markets and work with compliance teams to mitigate them


• Support Medical Director in giving medical input and observations relevant to the needs of the regional HCC team


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


• Assist Medical Director in full implementation of Celgene FMV processes across Partner Markets


• Ensure promotional material development for Celgene products is aligned with all internal and external regulations regarding compliant marketing

Safety and RMP

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


• Initiate and supervise implementation of agreed risk management plans in Partner Markets under the direction of Medical Director

B. Clinical Research and Development

Celgene international clinical trials

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


• Help attract selected trials according to local epidemiologic data, R&D local competencies and business potential


• Interface with KOLs, R&D teams and CROs where needed to assist execution of Clinical Program


• Build internal visibility and knowledge of Partner Markets capabilities, competencies, recruitment potential, data reliability and business potential

Local IITs

• Facilitate and support local IIT initiatives developed by local KOLs and that are aligned with agreed Celgene ODQs


• Coordinate internal process of approval and implementation

Regional and local trials initiatives

• Support the initiation of medical affairs initiatives such as observational studies, registries, publications

Skills and Knowledge Requirements

• Scientific education


• Business oriented


• Innovative mindset


• Experienced in 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


• Disease / therapeutic knowledge / expertise highly desirable


• 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


• Spanish and French an advantage

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