Description
EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
PURPOSE OF THE ROLE
To function as Study Director and design and direct clinical studies (Phase II and Phase III) as part of Global Clinical Development plans in specific TA for worldwide registration and to provide TA specific clinical input/support, as directed by the Head AND Deputy Head of the GCDU.
KEY TASKS & RESPONSIBILITIES
- Responsible as a member of the Trial Team for all medical & scientific aspects of the study from design phase, through implementation, and finalization, including scientific and medical input into the final review and sign-off of all pertinent clinical trial documentation.
- Responsible for assuring that study conduct is in compliance with all applicable national, and internationally accepted regulations.
- Reviews clinical research proposals within the therapeutic area for medical and scientific merit.
- Ensure publication plans and publication contents are scientifically and medically valid and compatible with the strategic messages of the TA
- Attend scientific and pharmaceutical and biotech industry meetings to remain abreast of new developments within the TA, and new developments in clinical research methodologies.
- Support Medical Affairs and marketing by providing specialist input in Ph IV clinical trials, pre and post launch activities, by attending conferences and supporting KOL development.
Requirements
CANDIDATE’S PROFILE
Academic and Language Requirements
- Medical Degree
- Fluency in English
Years and Type of Experience
- Minimum of two years of experience in drug development in the pharmaceutical or biotech industry. Must have experience in one or more of the Merck Serono TAs.
Professional Competence
Knowledge
- General knowledge of clinical research.
Skills
- Ability to adjust clinical trial designs for safety reasons and/or to optimize opportunities
- Ability to analyze, interpret, present and publish clinical study results
Personal Qualities
- Commitment to ethics and scientific standards
- Open-minded and flexible to adopting new ideas
- Convincing and effective communicator
- Oriented towards efficiency and results driven
Team player
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.
E-Mail to a Friend
Add to Job Folder