JOB TITLE: SCIENTIFIC PROJECT LEADER

Organization: «The Rosalind & Morris Goodman family pediatric formulations Centre of the CHU Ste-Justine»

Responsible to: General Manager

Location: CHUSte-Justine, Montreal, Quebec, Canada

Effective date: TBD

Full-time vs Part time (3-5daysaweek): to be discussed

MAIN RESPONSIBILITIES

·      To write Pediatric formulations (PERFORM) 1 development plans directed toward obtaining market authorization for pediatric formulations (see below for a brief description of PERFORM plan)

·      To participate and write sections of the Systematic Review, as required

·      To write clinical study reports, case studies and scientific publications

·      To work closely with the team to map the requirements of regulatory authorities (Health Canada, FDA, EMA…) for approval of pediatric formulations

·      To participate in the development of interfaces  with  existing  database  (e.g., RAMQ…) to help establish needs

·      To support the design and conduct of pediatric trials, as needed

·      To maintain clinical, scientific, and technical expertise in the field of pediatric formulations through continuous learning and knowledge of the related scientific literature

·      Liaise with key clinical stakeholders, as needed

·      To support the General Manager as needed with various tasks

Job Requirements:

·      Education: Pharmacy degree, in a relevant discipline[1] (voir note en bas de page)

·      A high level of scientific expertise with a proven ability to critically evaluate the medical literature,    interpret and effectively communicate complex clinical data

·      To be familiar with all aspects of clinical  research,  ideally  with  the  pediatric population

·      Advanced level of medical writing in English, a necessity

·      To have some knowledge regarding modeling and simulation approaches in the conduct of clinical trials

·      To have some expertise in regulatory affairs (submission to Health Canada)

·      To be able to interpret, analyse study data and write scientific articles and study reports

·      To be computer literate,with experience of word, excel, and powerpoint.

·      Good organizational skills and demonstrated ability to work autonomously, to be creative, and to “think outside the box”

·      Quick learner, good adaptability, demonstrateD strong leadership

·      Effective and demonstrated strong communication (both verbal and written) and presentation skills in English and French

·      Can easily adapt to change

In a context of growth and constant change, this job description summarizes the main aspects of the job, but it does not cover all the duties that the job holder may be required to perform.Therefore, the job description is a minimum standard. It is not a statement of all that the job does or may entail.It is not intended to restrict the scope of the job but clearly to define its starting point.

The PERFORM outline above includes the following secTions:

·      Is there a need for a commercially available pediatric formulation?

·      What are the consequences of not having such formulation?

·      What are the current state of knowledge regarding PK/PD/PG in children?

·      What are the characteristics of the ideal formulation?

·      Are there any suitable commercially available pediatric formulation(s) in other countries?


[1]Après vérification avec la responsable de l’offre, il n'est pas nécessaire que la personne soit un pharmacien si cette personne a de l'expérience clinique (et ceci préférablement en pédiatrie). Le besoin est pour quelqu'un qui a une expérience de clinique, qui connaît les maladies et médicaments ainsi qui aime rédiger des documents scientifiques. (Note ajoutée par : Denis deBlois, professeur, Faculté de pharmacie)