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Head of Medical development Woluwe-Saint-Lambert Belgium,  

ASIT Biotech (company)

Posted on : 01 December 2016

Project Description

In order to face the development of our activities, we are currently seeking a Senior Medical Director. This senior position will report 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.

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.
  • 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. 

About Us: 

We are  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.  We currently employ 22 staf memmbers, located at our headquarters and in the laboratory.


Woluwe-Saint-Lambert, Brussels, Belgium

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