Associate Medical Director
- Assists in execution of the Clinical Development Plan (CDP) for the compound within the selected indication(s).
- Assist in efficient and safe development of the compound in indication(s) assigned, including competent medical monitoring of individual clinical trials.
- Medical representation of the company to the outside world in relation to the assigned compound and indication(s).
Key Activities and Responsibilities
- Medical monitoring of trials, with focus on medical review of study documentation and individual patient information, investigator communication, and continuous safety evaluation (in cooperation with pharmacovigilance department).
- Author, and/or support writing, and/or reviewing of medical documents; such as clinical study protocols, investigator's brochures, clinical study reports, clinical development plans, manuscripts for publication of research results, literature reviews, internal and external presentations, newsletters, sections of INDs/CTAs, other regulatory documents. Support development of case report forms, statistical analysis plans (including study report tables and listings), and other related documents (e.g., automated query definitions) together with data management and statistics.
- Close interaction across the whole development team (medical + operational + regulatory + safety + data management/statistics + medical affairs etc.; both locally and internationally) to support efficient and safe conduct of clinical studies.
- Support of due-diligence processes when applicable. Establish and maintain close interaction with opinion leaders within the appropriate area of work (compound in selected indication(s)) to secure support for the clinical program.
- Oncology medical training and education of other employees when appropriate. To participate at preparation of Advisory Boards and Investigator’s Meetings.
Competences, Skills and Qualification
- MD with oncology or hematology specialization (one can also consider other MD specialization, but then longer industry experience in oncology/hematology is a pre-requisite).
- Sufficient drug development industry experience, i.e. at least 5 years. If an adequate time has been spent on drug development in academia, e.g. university or cooperative group setting, this could compensate for a shorter experience within the drug development industry.
- Experience from own work related to clinical study responsibility (i.e. as medical monitor of studies).
- Adequate knowledge of ethical principles and drug laws and regulations to be able to function as medical monitor of clinical studies.
- Experience from own work with medical review of important (preferentially pivotal) clinical studies.
- Experience from early and late stage clinical development.
- Experience from responsibilities related to leading/arranging investigator meetings, DMCs/DRCs/IDMCs, advisory board meetings.
- Experience in the basic medical bio-statistic and interpretation of clinical trial results.
- Experience in the field of pharmacovigilance incl. national and EU legislative knowledge.
- Ideally experience in medical marketing incl. development of marketing strategies/tactics.
- Ideally filing experience (mainly FDA and/or EMA, or possibly other).
- Management experience desirable. - International experience desirable.
Other Skills (language, IT):
- English, excellent verbal fluency and written proficiency is a must.
- Good knowledge of MS-Office.
- Dynamic, team- and goal-oriented, personality.
- Very good communication and presentation skills.
- Highest integrity regarding data assessments as well as interaction in team and company settings.
- Preferentially shown ability to work in global setting, including also settings managing junior colleagues.
- Good time management.
- Willingness to travel.