Prima BioMed is hiring.
Medical and Safety Advisor
Company: We are Prima BioMed, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, Germany and France, Prima BioMed is dedicated to bringing innovative treatment options to market for patients. The company is publically traded on the ASX and NASDAQ.
Location: Berlin, Germany
As a result of continuous progress in our projects we want to expand our team and therefor seek a Medical and Safety Advisor.
- Act as medical and safety representative for the clinical development programs in oncology (i.e. breast cancer and melanoma) and other indications
- Serve as medical and safety monitor (sponsor part only) for ongoing clinical trials; i.e. review SAEs/CIOMS, revise coding and medical reviews, review protocol deviations
- Be responsible for core documents within the clinical development i.e. clinical study protocol, clinical study report, DSUR etc.
- Review of and contribute to study specific documents; i.e. safety management plan, medical monitoring and medical review plan, statistical analysis plan, IDMC/DSMB charters etc.
- Create and maintain a clinical communication plan and publication strategy to build awareness of ongoing clinical trials and manage patient recruitment expectations
- Manage and liaise with investigators, key opinion leaders and study groups to evaluate ongoing clinical trials, and assess new clinical programs
- Evaluate internal and external clinical trial data
- Present key clinical findings to internal and external constituents
- Characterize, establish and re-state the benefit-risk profile of assigned product candidates
- Develop a safety and risk management strategy (incl. i.e. pharmacovigilance system) for assigned products necessary to support market approval
- Contribute in an active and ongoing manner to the scientific, clinical and commercial development of company’s product candidates
- MD or M.Sc. (or equivalent), MD preferred
- Minimum 3 years’ experience in a clinical research environment with exposure to the drug development process and participation in the design and conduct of clinical trials
- Strong interpersonal and negotiation skills
- Excellent Project Management skills
- Excellent technical/medical writing skills (English)
- Experience in international clinical trials
- High standards of integrity
- High energy level and strong self-motivation
- Must have working knowledge of international (FDA, EMA) regulations, GCP, PhRMA principles and guidelines, and similar compliance requirements
- Knowledge of immunology highly preferred
- Knowledge of oncology and immuno-oncology products is a plus
- Filing experience, BLA submission or MAA experience desirable (US/ EU/ other)
- Multifunctional interesting tasks in the emerging field of immune therapeutics
- Highly motivated and energetic international team
- Permanent contract, office based
- Competitive compensation
If you are interested in this challenging career opportunity, please send your CV, salary expectations, application letter and your earliest possible entry date until July 31, 2017 to the following e-mail address (confidentiality is of course guaranteed): email@example.com
In case of questions you are welcome to contact the Berlin office via 030 88716843.