13.09.2009Associate Director Clinical Investigations (m/f)
About AiCuris
AiCuris (name derived from 'anti-infective cures') is a pharmaceutical company focused on the discovery, research and development of novel antiviral and antibacterial agents for the treatment of severe and potentially life-threatening infectious diseases. AiCuris has its roots in Bayer's long history of successful anti infective drugs. Spun out in 2006 AiCuris owns a broad portfolio of R&D programs, compounds and intellectual property. The research fields in question are human cytomegalovirus (HCMV), Hepatitis, HIV, herpes and bacteria. On the one hand AiCuris takes existing heritage of anti-infective projects further through clinical development (actual up to phase II) and has on the other hand a strong commitment to identify new drugs by in-house discovery research.
The role of the Associate Director Clinical Investigations is to successfully design, conduct and report clinical phase II/phase III studies in collaboration with the AiCuris project team, external experts, CROs and regulatory authority. He/She will be helped full time with a Clinical Trial Manager (CTM) in addition to the help by the AiCuris project team.
Tasks
He or she
- is responsible for all aspects of clinical phase II/III studies
- is responsible for conceiving, developing and finalising the protocol with in house and external collaboration and get them validated with the experts in the field
- is responsible for answering and integration of comments from the authorities
- obtains quotes and organise the selection of suitable CRO
- conducts Budget/Contract negotiation and management
- supervises the management and timelines of the study
- makes sure that the study is conducted to the highest scientific and regulatory standards
- follows the set up, conduct and completion of the study with the help of the CTM
- be a medical advisor/reviewer: Answer questions to investigators regarding the protocol, the disease and the drug
- conducts medical review of the study data
- is responsible for reviewing and finalising the study report
- must be aware of bottlenecks and possible risks involved in a trial and outline solutions and implement them
- ensures the patient safety
Skills and Qualifications
- MD degree with proven experience in supervising/conducting phase II/III studies. Experience in anti infective studies and/or transplantation settings will be a plus.
- 5 or more years of experience in running clinical trials in Pharma / Biotech industry and with international cooperations
- Ability to work in team in house as well as with people from CROs, investigators, experts and opinion leaders.
- Good organisational skills, leader ship quality, good communication skills, capable of setting priorities, able to motivate the team, to manage high workload and stressful situations.
- Positive & constructive attitude, people management competencies and trustworthy
- Knowledge of working with specific software applications (esp. MS-Office, MS-Project)
- Business fluent in English and German
We offer an exciting and challenging job in an expanding and innovative company with an excellent R&D portfolio and a highly motivated team exhibiting many years of Big Pharma experience.
How to apply
To apply, please submit your full application inclusive your curriculum vitae and salary require¬ments exclusively via email.
Contact
AiCuris GmbH & Co. KG
Attn.: Mrs. Andrea Krema
Friedrich-Ebert-Str. 475/Building 302
D-42117 Wuppertal
phone: +49 202 317 63 0
fax: +49 202 317 63 1177
e-mail: jobs@aicuris.com
web: www.aicuris.com
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