- Medical lead for an indication or group of indications for a compound in development with main focus on oncology/hematology/(autoimmune diseases).
- Establishing and execution of the Clinical Development Plan (CDP) for the compound within the selected indication(s).
- 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).
- Line management and guidance of junior staff, e.g., Associate Medical Directors (if applicable).
Key Activities and Responsibilities
- Contribute in designing a clinical study strategy for each product candidate to demonstrate the efficacy and safety of the product candidate.
- Contribute as a member of clinical team to ensure effective x-functional communication and collaboration within Clinical organization and with other functions (e.g. manufacturing, science).
- Provide leadership in clinical project/program management of clinical trials.
- Provide medical leadership and clinical best practice for the SOTIO´s full therapeutic range, moving compounds through the clinical development process.
- 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.
- Close interaction with Regulatory Affairs department including medical support in association with e.g., regulatory interactions and preparations of regulatory documents.
- Close interaction with pre-clinical development scientists when applicable for e.g., medical support regarding selection and validation of new drug targets, medical interpretation of pre-clinical data, etc.
- 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.
- Monitoring of competitors within the appropriate area of work (compound in selected indication(s)).
- Contribute to the work of other divisions (manufacturing, supply chain, etc.) if needed and appropriate.
- 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.