Director Medical Affairs, Diabetes Care

Location: Indianapolis, IN
Date Posted: 10-21-2016
A pioneer in the development of blood glucose monitoring systems, Roche is committed to helping people with diabetes live lives that are as normal and active as possible and helping healthcare professionals manage their patients’ condition in an optimal way. The ACCU-CHEK® portfolio—from blood glucose monitoring through information management to insulin delivery – offers innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.

The Director Medical Affairs will develop and lead Medical & Scientific Affairs Department Diabetes Management & Platform Solutions (DMPS) within the area Global Medical & Scientific Affairs Roche Diabetes Care (GMSA RDC),  including responsibilities for development, personal progress and management of staff, management of new hires and departmental budget according to business plan.

Responsibilities include:

• Be an Expert in Medicine with extended (clinical) knowledge in Diabetes Management / in Medical Value Concepts supporting Diabetes therapy processes and in Medical Device Development including specific skills in the area of Digital Health and Mobile Health.

• Use and apply accepted and established medical and clinical knowledge and strategies to support RDC and GMSA strategy, the Accu-Chek portfolio (specifically DMPS portfolio) and the related product  development

• Support further development of the Medical Rationale and Strategy for the area of  DMPS and contribute significantly to the DMSA portfolio roadmap through close collaboration with GPS DMPS, R&D and R&T.

• Support DMPS product development mainly through advice on medical product specification also through DMPS product risk assessment and clinical evaluation.

• Generate strong Medical Evidence for DMPS Portfolio through the development of clinical study designs and study outlines and the support of the implementation of final clinical study protocols

including scientific advice for running studies – or delegate to GMSA DMPS staff (Scientific Advisor function)

• Generate an annual updated RDC-Clinical Trial Plan for the area of DMPS in alignment with and involving of global RDC departments (e.g. R&T, R&D and GPS) and ComOps of regions and countries.

• Develop, manage and collaborate closely with a strong medical & scientific network of experts and partners internally, in Roche Diabetes Care, Roche Diagnostics and Roche Pharma and externally with local and international Key Opinion Leaders (KOLs), HCPs and representatives from payers. Build specific network in to digital health, mobile health and health oriented consumer electronics

• Collaborate closely with the Heads of Medical & Scientific Affairs Departments and the Regional Medical Affairs Departments and ensure impactful medical knowledge transfer (active and passive) for RDC

Qualifications include
• Doctoral degree in medicine with 2 years clinical experience

• 8+ year’s experience in FDA regulated industry with thorough knowledge of product development and clinical studies to support regulatory submissions or generate medical evidence/outcome data

• Experience in dealing with clinicians, senior business leaders and regulatory authorities

Preferred:

• Experience in Diabetes / digital – mobile health arena
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

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