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Head of Medical development Woluwe-Saint-Lambert Belgium,  


Posted on : 01 December 2016

Project Description

In order to face the development of its activities, ASIT biotech is currently seeking a Senior Medical Director Senior Position reporting to the CEO Purpose of the Position: Provide medical input for and oversight of clinical development plans and clinical trials for assigned projects in Allergology / Respiratoty Diseases Provide medical expertise for project strategy and business plans. Key Responsibilities: Operational aspects o Provides medical rationale, discussion of disease and context of treatment for protocols, IBs, clinical study reports and other supportive documents o Leads clinical trial design including trial synopsis in collaboration with other involved functions o Is responsible for medical monitoring/supervision (directly or via management of CRO medical monitors) of clinical trials in accordance with GCP, including responding to medical questions from investigators, regulatory authorities and ethics committees o Reviews, interprets and provides conclusion on safety, PK/PD and efficacy data from clinical trials within therapeutic area in collaboration with relevant functional or external experts o Reviews and approves protocols, IBs, core ICFs, clinical sections of IMPD/IND and clinical study reports within therapeutic area and within context of GCP o Provides input to process improvement initiatives including developing and/or review of SOPs o Oversees the conduct of clinical trials o Provides a medical input in all key documents of the study related documents (protocol, investigators brochure, safety guidelines, procedures, ..) o Signs the clinical trial protocol and Clinical Study Report as Medical Responsible Person o Ensures medical review of the clinical data o Reviews the Medical History, Adverse Events and Concomitant Medication coding lists o Signs protocol deviations when necessary o Pharmacovigilance : is the contact person from the company for the Safety Coordinator if necessary. 2 o Ensures medical review of Annual Development Safety Updated Reports (DSUR) Pediatric Investigational Plan (PIP) o Is the interlocutor with Investigators Key opinion leaders o Represents BTT at Scientific advices, Advisory boards, Scientific meeting, Investigators Meeting, Blind review meeting Strategic aspects o Leads clinical development strategy and recommends target indication / patient population / clinical endpoints, for assigned therapeutic area programs and ensures alignment with project strategy and deliverables as well as with regulatory and therapeutic guidelines as indicated o Makes clinical benefit risk assessment and document in clinical development plans, protocols, IBs o Generates and reviews publication strategy and manuscript and/or presentations of clinical trial results o Identifies and develops relationships with external clinical and scientific experts and investigators to support the clinical development programs o Provides medical and clinical development support for business development activities o Act as mentor, additional sounding board for medical team on ad hoc basis Working Relationships: Internal Contacts: Medical team, ExCom, Clinical Operations & Supplies, Regulatory/Medical Writing, Biostatistics/Data Management, Pharmacology, Toxicology, Pharmacometrics, Project Management, Project Planning, Discovery, Business Development, Medical Marketing, Legal, QA External Contacts: Clinical Experts, Clinical Trial Investigators, Contract Research Organisation Medical Monitors and Project Managers, Regulatory Authorities, Ethics Committees, (Potential) Partners Skills, expertise and contribution: Strong sense of responsibility. Strong communication and organizational skills, team player, time management, flexibility, strong project management skills, problem solver. Very good knowledge of English (spoken and written). Willingness / ability to work in a matrix environment and evolving corporate structure. Willingness / ability to travel nationally and internationally. Strong initiative and ability to work with minimal supervision. 3 Detail oriented, methodical and goal driven. Fluency in Windows and Microsoft Office (Word, Excel, Access, PowerPoint). Ability to manage multiple and varied tasks and prioritize workload with attention to detail. Minimum Qualifications: Expected educational qualifications: Medical degree. Expected experience: minimum of 10 years relevant experience in clinical development in allergology / Respiratory Diseases (including phase I to III) e.g. as clinical research physician, medical lead with at least 5 years in management function. Should be well-versed in GCP. EMA and FDA environment knowledge. Applicants should send their CV to: Mr. A. Vicaire (albert.vicaire@biotech.be with reference to Senior Medical Director Application. About ASIT biotech ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotechs product pipeline entails two novel ASIT+ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+ platform is flexible and would be applicable across a range of allergies. gp-ASIT+TM, our product candidate for the treatment of grass pollen rhinitis consists of a mixture of natural allergen fragments obtained from a purified specific proteinic ex- tract from Lolium perenne pollen. In contrast to the synthetized peptides, the natural peptides (70% of the fragments ranging from 1,000

Locations

Woluwe-Saint-Lambert, Brussels, Belgium

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