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Senior Director, Scientific & Medical Affairs
Deze vacature staat offline! | | De opdrachtgever
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Kendle, Clinical Research Organisation in Utrecht.
| | Algemeen
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To provide overall scientific leadership for the Kendle Early Stage - Netherlands, including overall oversight for clinical operations and conduct of clinical research projects.
- Responsible for the development of clinical research projects and their analysis.
- Responsible for overall health and safety standards for clinical research projects.
- Provides direction to the Clinical Pharmacology group for Kendle Early Stage - Netherlands.
- He / she is a therapeutic expert, serving as a consultant both internally and externally in his / her area of expertise.
- Carries out role of Qualified Investigator.
| | De omschrijving
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- Responsible for overall scientific development and implementation of research projects within assigned therapeutic areas; this will include initial and follow-up contact with sponsors' scientific officers resulting in signed contracts and successful project completion.
- Coordinates scientific and medical development and completion of concept protocols (or consulting project reports), final protocols, data analysis and interpretation, draft and final report preparation, review and finalization.
- Establish and communicate study design standards to the scientific and statistical teams.
- Ensure scientists and statisticians are up-to-date on Kendle Early Stage’s current best scientific practices.
- Represent Kendle Early Stage at conferences, scientific meetings, regulatory meetings and client meetings.
- Critically review and evaluate the scientific merit of potential projects.
- Provide scientific input and guidance to other Research Scientists and Statisticians.
- Conduct literature reviews and provide scientific support for assigned projects including complex scientific projects.
- Advise supervisors and colleagues in areas of expertise.
- Provide scientific consulting.
- Provide extensive input on study design.
- Design and write concept protocols, full protocols and informed consents.
- Assist in writing and reviewing project reports, expert opinions, investigator brochures.
- Prepare abstracts, papers and manuscripts for publication or presentation.
- Participate in national and international scientific meetings as appropriate.
- Project manage consulting projects.
- May act as team leader for combined consulting/clinical research projects, coordinating assigned resources and communicating with sponsors.
- May direct the work of other professional staff in the accomplishment of assigned goals and assist in training, development and evaluation activities.
- Serving as an internal resource for training and advice to NBD and project teams. He/ she keeps up-to-date with relevant developments and implements if necessary.
- Takes an active part in the NBD effort for the Brand. Depending upon office location and specific circumstances, this may include: identifying target customers; establishing new customer relationships; maintaining existing customer relationships; identifying market trends and opportunities; generating business and project leads; managing public relations; attending exhibitions and conferences; representing Kendle to sponsors and potential sponsors when they visit his / her office; making sales calls. These activities are coordinated with NBD, Sales & Marketing Support, Marketing and Corporate Communications and other Brands as appropriate.
- Proactively involve himself / herself in appropriate industry associations, community bodies and other relevant forums to help promote Kendle in drug development community.
- Approves medical and clinical SOPs.
| | De eisen
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MD level degree, preferably also a PhD, with a minimum of 15 years of relevant pharmaceutical and CRO experience or equivalent. Experience in an international environment is an advantage; New Business Development experience would be considered an asset.
In addition to being qualified by education and experience as described above, the Senior Director, Scientific & Medical Affairs must have a record of superior performance in similar or less senior positions within Kendle or a similar organization and must possess the knowledge and technical / management skills requisite for success as a Senior Director, Scientific & Medical Affairs. Must demonstrate excellent leadership and managerial capability. These include, but are not limited to, an ability to act independently and pro-actively, personnel management, customer management, financial management, project management, sales, communication, interpersonal skills and an excellent command of the English language.
| | De arbeidsvoorwaarden
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| | Contactinformatie
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550 |
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Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar arjan@pharmamediair.nl.
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