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.
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
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
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.
- 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.
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.