SOTIO je dynamicky se rozvíjející biotechnologická firma, která vyvíjí nové léčebné terapie zaměřené na léčbu nádorových a autoimunitních onemocnění. Společnost buduje diverzifikované portfolio produktů založené na vlastním výzkumu a vývoji, spolupráci s partnery, licenčních dohodách, investicích, fúzích a akvizicích. Je součástí skupiny PPF a působí v Evropě, USA, Číně a Rusku.
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.
Informace o pozici
Praha-Holešovice, Česká republika
Typ pracovního vztahu
Práce na plný úvazek
Typ smluvního vztahu
Délka pracovního poměru
Na dobu neurčitou
Vysokoškolské / univerzitní
170 00 Praha 7-Holešovice