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Posted Date: 02 September 2010

Ref No.: HS-GBMD

Region: Basel

Job Description

I am looking for a Global Brand Medical Director for my client in Basel Switzerland.

General Brand Medical Director responsibilities:

*Leader of the International Clinical Team and lead clinical representative of the International Project Team.
*Provide clinical leadership and accountable for:
a. global clinical strategy as the lead author of the Confirmatory and/or Life-cycle management Clinical Development Plans (C-CDP & L-CDP) aligned with the Target Product Profile, individual protocols consistent with CDP; clinical components of regulatory documents/registration dossier; Brand Optimisation Strategy Plan in close collaboration with Health Economic & Outcome Research (HE&OR) and Marketing; brand related medical information, clinical communication and publications; input to Value Dossier; brand-related input to Therapy Area (TA) strategy.
b. Phase II-IV global and local clinical program designed to obtain registration and market access, and to optimise the brand value during the entire life cycle, in partnership with key stakeholders from both strategic and day-to-day operational perspective.
c. final approval of clinical documents (e.g., Investigators' Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
d. safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Integrated Medical Safety.
e. medical/scientific training of all relevant stakeholders regarding the brand.
f. delivery of all medical components needed for maintenance of product licenses (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority).
g. resource planning and management (FTEs and budget) for the clinical program with support from resource managers.
h. accountable for timely execution of clinical deliverables within approved budget.
*Provide clinical leadership in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Exploratory Development, Marketing, HE&OR), and internal decision boards.
*Accountable for providing brand-related medical input to TA strategy, (e.g., pruning, divestment, in/out licensing) through participation on the Clinical Science Board.
*Accountable for talent and career development of direct reports including performance management. Contributes to the talent and career development of TA staff through active participation in on-boarding, training and mentoring activities.
*Contribute to cross-functional initiatives (e.g., faculty member for Clinical Development training programs, author or reviewer for clinical SOPs).

Global Brand Medical Director requirements:
Education:
MD required. Advanced knowledge in medical/scientific area required.
Languages:
Fluent oral and written English

Experience/Professional requirement:
*Involvement in drug development spanning clinical activities in Phases II/IV or comparable experience in industry.
*Demonstrated leadership and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or section of clinical programs in a global/matrix environment (including remote) in pharmaceutical industry.
*Experience in neurology and/or psychiatry, preferably in the field of epilepsy
*People management experience required, this may include management in a matrix environment. Global people management experience desirable.
* Strong management, interpersonal, communication, negotiation and problem solving skills.
*Considerable organisational awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
*Medical/scientific and operational expertise appropriate to the program.
*Demonstrated technical knowledge and innovation in clinical development study designs that provide relevant evidence to decision-makers.
*Prior history with post-marketing/brand optimisation studies to obtain evidence of brand value and support commercialisation activities preferred.

Randstad Technologies plc is a leading specialist recruitment agency for the IT industry. Randstad Technologies is also one of the founding members of The Association of Professional Staffing Companies (APSCo). Due to the high level of applications we receive, please be aware that you may not hear from us immediately, as we can only respond to those applicants whose skills and qualifications are suitable for this position. If you would like Randstad Technologies to help you find a similar position, or for a complete listing of all our current vacancies, please visit our website at www.Randstad Technologies.com and register your details. Please note that no terminology in this advert is intended to discriminate on the grounds of age, and we confirm that we will gladly accept applications from persons of any age for this role.

Salary Indication:

Competitve Salary