CROMSOURCE

Medical Director, Germany - L

Company
CROMSOURCE
Location
Germany
Salary
Competitive
Posted
30 Apr 2021
Closes
30 May 2021
Ref
HQ00002526
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Medical Director in Germany to join our client-based team at one of the leading global biopharmaceutical companies.

Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.

As Clinical Development Physician, you will be responsible for providing medical/scientific input and expertise ensure the medical/scientific coherence and quality of clinical development programs conducted in the assigned disease area, and contribute to the generation of the Clinical Development Plan(s) leading to successful registration and launch of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds.

Main tasks and responsibilities:
  • Contribute to the design, conduct and interpretation of specific clinical trials, specifically their relevance for the target disease and drug candidate
  • Ensure the study-related safety of the subjects in the clinical trials through appropriate medical monitoring of studies on an ongoing basis - with or without independent data and safety monitoring boards
  • Contribute to the clinical section of documents including, but not limited to, the Investigator Brochure (IB), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview
  • Translation of Medico-scientific innovation for corporate projects
  • Assuming responsibility for correct and updated medical/scientific information for the respective therapeutic field and ensures its incorporation into the Clinical Development Plan (CDP)
  • Assuring medical/scientific integrity of clinical development programs and their deliverables (e.g. protocols, clinical trial reports, etc.)
  • Being the medical contact person with the investigators, the MD is the frontline representative towards the medical community
  • Being responsible for subject inclusion issues and subject management issues that require medical judgment
  • Reviewing medical data, perform medical checks of that data when necessary and interacting with the investigator during the study. Medical monitoring includes on-site visits as appropriate to the complexity of the protocol
  • The MD will also play a major role in the pre-analysis meeting
  • Providing medical input in the database cleaning strategy (e.g. Data Cleaning Plan) to ensure adequate and efficient data cleaning
  • Analysing the study results and report findings in the CSR and recommend new paths based on the lessons learned
  • Provide training and ongoing input to all members of the Clinical Team and the Clinical Study Team on medical/scientific issues related to the therapeutic field in question
  • Establish, develop, and maintain contacts worldwide with key opinion leaders and experts of assigned therapeutic area and disease area
  • Serve as global medical/scientific spokesperson for the company with the internal and external community including various regulatory and governmental agencies


Requirements:
  • Medical qualification (MD) required
  • Min 5 years of experience in pharmaceutical industry in clinical development (Phase 1-4), including knowledge of GCP
  • Board certification or other relevant higher medical and academic qualification preferred, within Neurology
  • Clinical Development Experience with Neurology


Skills:
  • Clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent the company internationally at meetings and congresses


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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 the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

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 Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002526

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Medical Director, Clinical Development Physician, Neurology, Clinical Development, GCP, Pharma, Pharmaceutical
Skills: Neurology, Medical Director, GCP, ICH-GCP, Pharma, Pharmaceutical Location: Germany Share:

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