Clinical Research Leader

  • Location: Brussels
  • Type: Contracting
  • Job #17833

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Clinical Research Leader

This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES
Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:
• Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Operating Company;
• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
• Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials;
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
• Oversees and supports the development and execution of Investigator agreements and trial payments;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Supports planning, track and manage assigned project budgets to ensure adherence to business plans;
• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
• May serve as the clinical representative on a New Product Development team;
• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims
and messaging;
• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Generally manages work with limited supervision, dependent on project complexity.
Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.

EXPERIENCE AND EDUCATION
Education
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience
• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Experience working well with cross-functional teams is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS

Functional and Technical Competencies:
• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects;
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Demonstrate competencies in the following area are required:
• Behave and lead in a professional and ethical manner
• Advanced project management skills with ability to handle multiple projects

Leadership Competencies:
Ability to lead small study teams to deliver critical milestones, as may be assigned. Leadership required in alignment with Company Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities.
• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver – Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance with SOPs and regulations.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now by clicking on the button!

 

 

Technicien Plasturgiste

  • Location: Brussels
  • Type: Contracting
  • Job #19700

Technicien(-ne) plasturgiste 

#chimie #matériaux #polymères #composite #plasturgiste

Vous avez des connaissances en plasturgie ? Vous savez travailler en équipe ? Vous aimez le travail manuel ? Dans ce cas, continuez de lire le descriptif de votre futur emploi !
Notre partenaire est activement à la recherche d’un Technicien(-ne) plasturgiste pour venir compléter son équipe.

Vos responsabilités ?

En tant que technicien(-ne) plasturgiste, vous participerez à la production de pièce polymère composite pour une application dans le secteur automobile ou aéronautique :

  • Préparation et découpe (via robot) de bobine de fil ou de feuille de polymère 
  • Soudure de plaque polymère (par systèmes automatisés)
  • Transformation (thermo formation, pressage de différentes couches) par pilotage de machine (ex : extrudeuse, presse à injecter, presse a plateau) de laboratoire  
  • Réaliser un relevé de condition de mise en œuvre via des Outils Excel : Encodage des informations dans un fichier de condition pour le comportement du polymère, information sur les différentes matières et leur aspect
  • Petite intervention maintenance (démontage pièces mécaniques…)

Votre profil ?

  • Diplôme en plasturgie, électromécanique, mécanique ou chimie
  • Vous avez un intérêt pour les matériaux composites
  • Utilisation basique des outils informatiques tels qu'Excel, Word, …
  • Vous êtes orienté(-e) résultats
  • Vous aimez travailler en équipe
  • Vous êtes rigoureux, flexible, vous prenez des initiatives et vous êtes autonome

Notre offre ?

Un CDI avec un package salariale correspondant à votre expérience et compétences. L'opportunité de développer vos compétences au sein d'un grand groupe Chimique de renommée internationale.Si vous avez des questions n'hésitez pas à contacter Sophie Rolis : [email protected]

Opérateur de Laboratoire

  • Location: Brussels
  • Type: Contracting
  • Job #19388

Opérateur de laboratoire

Bruxelles – Consultance

#chimie #opérateur #laboratoire #matériaux #polymères #composites #caractérisation

Notre partenaire de l'industrie chimique est activement à la recherche d’un Opérateur de laboratoire pour venir compléter son équipe au sein du département en charge de l’analyse des polymères et des matériaux composites.

Quelles sont vos responsabilités ?

En tant qu’Opérateur de laboratoire, vous participerez à la préparation des échantillons basés sur des matériaux des clients de notre partenaire. Pour exceller dans ce rôle, voici vos principales tâches :
 

  • Vous prenez en charge la demande après discussion avec le Responsable technique
  • Vous exécutez la demande en suivant une procédure préalablement établie.
  • Vous renseignez les données de traçabilité et de contrôle.
  • Vous présentez et discuter des résultats avec le Responsable technique.
  • Vous utilisez des outils de découpe et d’usinage afin de préparer les échantillons qui seront utilisés dans les autres laboratoires du département.

Qui êtes-vous ?

  • Vous êtes titulaire d’un diplôme avec une orientation en mécanique/plasturgie/chimie.
  • Vous avez une bonne connaissance des matériaux et vous avez une première expérience au sein d’un atelier mécanique.
  • Vous avez, idéalement, une première expérience sur fraiseuse, scie ruban et/ou tronçonneuse.
  • Vous savez utiliser les outils informatiques suivants : MS Office et Google suite.
  • Vous êtes une personne orientée résultats et client.
  • Vous savez travailler en équipe et vous n’hésitez pas à prendre des initiatives.
  • Vous êtes une personne autonome, précise, rigoureuse et minutieuse.

Que pouvez-vous attendre ?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matière technique ainsi qu’au niveau des soft skills. Nous serons votre partenaire de carrière à chaque étape du processus.
Intéressé.e ? Nous vous invitons à envoyer votre candidature à l’adresse suivante : [email protected]

MSAT Process Engineer Cell Culture/USP

  • Location: Brussels
  • Type: Contracting
  • Job #17503

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

MSAT Process Engineer Cell Culture/USP

Our partners innovate to bring treatments to their patients that significantly improve their lives. Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.

For one of our pharmaceutical partners we are looking for a MSAT Process Engineer Cell Culture/USP.

Job description
Our client is a biopharmaceutical manufacturing site of therapeutic proteins. These proteins are produced through cell culture processes in bioreactors, followed by a purification process. The Manufacturing Science and Technology department (MSAT) provides the scientific backbone to enable the use of these complex biotechnological processes.
The focus of the here described function is on the upstream cell culture part of the process. Starting from thorough scientific and technical knowledge, you contribute to the start-up of new production lines and improvement and monitoring of existing processes at the site and the broader network of our client through:

Main Responsibilities

  • Development of second-generation processes for existing commercial products using small scale models for studies conducted in lab environment
  • Technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale
  • Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
  • Supporting and safeguarding existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments.

Who are you?

Profile

  • You have (preferably) a PhD in Life Sciences, with relevant in process development or MSAT-like functions
  • You have fluent English speaking and writing skills, knowledge of Dutch is a plus
  • You have specific experience with growing mammalian cells in bioreactors; either on lab- or production scale
  • You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail and can handle multiple tasks at once
  • You have excellent writing technical/scientific writing skills (protocols & reports)
  • You are flexible and willing to support both manufacturing scale operation and set up small scale lab studies
  • You have knowledge of cGMP
  • You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
  • You like to work in team and consider yourself to be a good team player.
  • Flexibility, stress resistance, openness to change & innovation and eagerness to meet deadlines are characteristics of you.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

 

 

APD Analyst

  • Location: Brussels
  • Type: Temp
  • Job #15803

QC Incoming Lab Technician

#QC #HPLC #Pharmaceutical #Techncian #Lab #Pharma #GMP

Vos responsabilités ?

  • Gérer les activités des analyses de composants, raw materials, produit fini et produits de stabilité au sein de laboratoire
  • Revoir les données GMP telles que les données brutes des logbook, AMBRs, etc.
  • Suivre les CAPA et Change Control en lien avec le laboratoire et activités Incoming
  • Gérer les rapports et interprétation de donnés scientifiques
  • Veiller au housekeeping et au suivi des règles GMP et des règles de sécurité dans le laboratoire
  • Vérifier la qualification des équipements du laboratoire
  • Participer au management de réactifs au sein du laboratoire
  • Participer aux projets d’amélioration au sein du laboratoire

Votre profil ?

  • Minimum Bachelor's ou Master's degree (Chimie, Biologie, Biochimie etc.)
  • Expérience avec des techniques physico-chimiques (HPLC, GC,…) au sein du QC ou dans un laboratoire d’une entreprise pharmaceutique
  • Esprit scientifique
  • Français et anglais courant
  • Maitrise de Windows et MS Office
  • Bonne gestion du stress, proactif et réactif, problem solver

Notre offre ?

Notre client vous offre un package salarial attractif complété d’avantages extra-légaux ainsi que l’opportunité de vous épanouir dans une fonction challengeante au sein d’une entreprise de renommée internationale et en évolution permanente. Si vous êtes intéressé, n’hésitez pas à me contacter, Dimitri Soupart : [email protected]sonwells.be