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Job Details

Leader Strategic Medical Affairs

Location: United States
Reference: HQ00001127
Closing Date: 21 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Leader Strategic Medical Affairs Colorado, USA   CROMSOURCE is looking for a Leader of Strategic Medical Affairs to work with one of our partner pharmaceutical companies in the USA.     The Leader of Strategic Medical Affairs will lead the efforts in setting up the protocol design for a prospective Neuro-Muscular Disorder study in collaboration with the Clinical Affairs team.     The successful candidate will be working on studies dedicated to one client.


Leader Strategic Medical Affairs

Colorado, USA

CROMSOURCE is looking for a Leader of Strategic Medical Affairs to work with one of our partner pharmaceutical companies in the USA.

The Leader of Strategic Medical Affairs will lead the efforts in setting up the protocol design for a prospective Neuro-Muscular Disorder study in collaboration with the Clinical Affairs team.

The successful candidate will be working on studies dedicated to one client. This position can be either office based in Denver, Colorado or home based within reasonable distance from the office for occasional visits.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Essential Function:

The Leader of Strategic Medical Affairs will be responsible for strategic leadership, management, direction and implementation of global Medical Affairs strategy for therapeutic systems and play a lead role in the life-cycle management of the pharmaceutical company's technology. Assume lead responsibilities in the planning and execution of medical advisory boards, clinical study design, implementation and management including medical monitoring and publication planning. The aim is to work within a cross-functional team (Global Marketing, Medical Affairs, Market Access, Regulatory …) to get approval for new indications. The position includes extensive engagement with external Key Opinion Leaders and internal engagement across various departments.

The Leader of Strategic Medical Affairs will provide support of medical communications strategy development and implementation, and meetings with major healthcare providers and medical associations. A high degree of scientific and medical competency is required for this position, along with strong business acumen, the ability to work both independently and within core teams to develop and successfully implement the Medical Affairs objectives of the company.

Main Responsibilities and Accountabilities:

· Responsible for collating unmet scientific and medical needs for Therapeutic Systems

· Oversee clinical trial execution, including monitoring activities and working with the Clinical Affairs team

· Contribute medical and scientific support to the development of new indications and appropriate communication strategies for existing technologies.

· Work closely with all Medical Scientific Liaisons and Senior Managers within the Medical Affairs team to ensure strategic intent meets tactical implementation (seamless transition between upstream and downstream Medical Affairs).

· Provide leadership and oversight through the provision of strategic medical input to global development of clinical, pre-registration, label extension, pre and post market launch strategies and life cycle management of corporate technologies.

· Provide insights into the design and execution of corporate-sponsored global clinical studies, including protocol and other study document development, site selection and initiation, study center and investigator oversight, engagement with ethics and competent authority committees, publication planning, preparation and presentation.

· Liaise strategically and cross-functionally with internal colleagues to identify needs and opportunities and to develop key medical initiatives to address and support respectively.

· Oversight of Medical Affairs advisory boards including content development and presentation, moderator identification and preparation, liaison with invited attendees, creation of meeting summaries and implementation of strategic output.

· Leverage data and scientific acumen in the development and launch of commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling strategies to drive the success of corporate initiatives.

· Maintain strong Key Opinion Leader relationships to identify new medical opportunities for existing or new corporate products, to pursue new indications.

· Maintains expert knowledge and understanding of clinical, scientific and technical information in therapeutic systems through continuous literature review, conference attendance and liaison with experts, and serves as an expert resource to internal colleagues.

· Attend scientific meetings to foster and develop strong relationships with national and international thought leaders and investigators.

· Collaboration with internal and external health economics and market access specialists in the development of clinical/financial value propositions for corporate technologies.

· Provide leadership and oversight in the design and implementation of health economic and outcome research needed for all studies pertaining to new indications.

· Work collaboratively in cross-functional teams of diverse stakeholders to identify solutions to medical/scientific barriers to successful implementation of corporate objectives.

· Work in and enable a positive team environment and interact with global clinical, scientific and marketing teams.

Education / Qualifications / Experience:

· Advanced degree: PhD in bio-medical sciences or PharmD or Medical Doctor (MD, DO) or equivalent.

· Substantial experience in the pharmaceutical industry in Medical Affairs is required.

· Board certification/Eligibility or equivalent in Neurology, or tenured relevant experience is preferable.

Skills and Knowledge:

· Strong knowledge of GCP, scientific and clinical methodology, clinical protocol design and project management skills.

· Extensive Medical Affairs experience to include a well-documented history of prior excellence through the identification, development and implementation of major Medical Affairs initiatives involving cross-functional teams of internal and external stakeholders and/or lead participation in major internal or external initiatives to successful conclusion.

· Experience gaining approvals in the Medical Device arena

· Proven ability to build productive relationships and teams internally and externally and the ability to develop high potential subordinates into leadership roles.

· Working experience with health economics and/or market access initiatives is strongly preferred.

· Reputation as open, available, transparent and credible communicator.

· Strong leadership and organizational skills.

· Represents the Medical Affairs team to the highest ethical, legal and professional standard in the execution of their responsibilities.

· Demonstrated ability to relate with Key Opinion Leaders on a high level.

· Didactic skills: ability to educate sales people as well as customers (physicians, clinicians).

· Able to present scientific data both at an individual level as well as presenting to an audience.

· Fluent in English language with excellent oral and written communication skills.

· Ability to travel 30 - 60% nationally/internationally.

Why choose TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge

CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Key words: Strategic Leader, Medical Affairs, Strategy, Med Affairs, Head of Medical Affairs, Medical Affairs Lead, MD, Protocol Design, Neuro-Muscular, Contract Research Organization, CRO, Outsourced, Pharmaceutical, Pharma, Freelance, Contract, Contractor, Consultant, Temporary

Medical Affairs, Freelance

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Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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