Medical Director Hematology

Medical Director Hematology


Mont-Saint-Guibert, Belgium

The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the VP Head Global Clinical Development and Medical Affairs located in Belgium.

Role & Responsibilities

  • Provide medical guidance and leadership throughout the development and conduct of clinical trials;
  • You will be responsible for overseeing development of the functional strategy, designing and/or managing the implementation of the clinical strategy within Clinical Development both regionally and globally.

Quantitative aspects of the role

  • Manage global or regional therapeutic or research projects within the Oncology arena;
  • Act as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials;
  • Additional responsibilities include compliance with adverse event reporting, and all pharmacovigilance (PVG) regulations and guidelines. You will ensure projects adhere to Good Clinical Practice and regulatory requirements;
  • Closely follow medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans;
  • Liaise with the internal and external medical community to follow developments within areas of expertise;
  • Maintain a high degree of understanding and awareness on new and emerging medical development;
  • Follow important developments and trends in scientific literature and develops contacts with opinion leaders;
  • Lead regulatory communication and preparation of higher level documents;
  • Respect of milestones.

Qualitative aspects of the role

  • Ensure the quality of given medical advice;
  • Enforce scientific and medical quality of all clinical trial documents (including the Investigator’s Brochure and the CSR);
  • Interface with the Program Director & R&D Leaders (to ensure milestone realization and resource optimization);
  • Increase the recognition of the company and the products within the scientific and medical communities.

Global Responsibilities

Lead Clinical Development activities for a series of studies

  • Interface with the clinical team to develop clear clinical trial strategies, design study protocols, monitor, document, and interpret clinical study data;
  • Provide medical support to clinical operations team;
  • Implement safety strategy across studies, including regular review of safety data and response to safety issues including communications with investigators and regulatory agencies;
  • Review AEs, SAEs, lab data, tables, listings, & graphs; provide medical assessment and instruct staff in appropriate query and follow up activities;
  • Perform medical assessment for expedited reporting, IND & EU annual reports, FDA Periodic Reports, and Periodic Safety Update Reports, SUSAR reporting, etc.;
  • Lead medical sections of regulatory documents in EU and US ; assist team with preparations for regulatory agency meetings and reports, including patient and safety narratives;
  • Assure medical consistency within trial and across trials;
  • Provide guidance to biometrics staff on data collection, statistical analysis planning, and blinded/unblinded TFL review.

Serves as scientific reference for the franchise (internally/externally)

  • Represent Celyad in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed;
  • Publish clinical data in peer review journals and present in external scientific meetings/congresses;
  • Responsible for follow-up of project related literature;
  • Manage Key Opinion Leaders;
  • Contribute to the clinical components of “Due Diligence” and other clinical activities in support of Business Development;
  • Provide medical support to Marketing in order to achieve Company’s objectives;
  • Manage Clinical Steering Committee and Advisory Boards;
  • Provide performance feedback on matrix team members to responsible line managers;
  • Travel up to 50% of his/her time.

Time repartition:

  • 10% - Strategy;
  • 30% - Leadership;
  • 40% - Operations management;
  • 20% - External relationship.

Qualifications & Experience

  • Medical degree and experience as a physician or academic;
  • Therapeutic area expertise, in particular Oncology;
  • Specialty training in Oncology is highly desirable;
  • Experience working within Immuno-Oncology is highly desirable;
  • At least 3 to 5 years clinical experience in biopharmaceutical, biotechnology industry;
  • At least 3 years drug safety experience in biopharmaceutical, biotechnology industry;
  • Sound scientific background required to critically evaluate all scientific aspects of oncology/immunology;
  • Knowledge of clinical stage drug development efforts, including typical hurdles and challenges, and experience in mitigation strategies. Experience in designing, monitoring and implementing clinical trials and interpreting trial results;
  • Experience interpreting clinical data and managing safety strategy;
  • Experience preparing and reviewing documents for clinical development to ensure high-quality document submissions health authorities and regulators (knowledge of biomedical research regulation);
  • Knowledge of assays and metrics for safety, clinical, and clinical outcomes;
  • Experience of cross-functional team with diverse skill sets (matrix organization);
  • In possession of an network in this field;
  • Recognized expert.

Skills & Competencies

  • Self-motivated, approachable, articulate team player who values collaboration and transparency and who possesses the highest level of integrity;
  • Ability to instill optimism and a can do attitude;
  • Ability to independently research questions;
  • Ability to critically analyze information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks;
  • Ability to understand high level corporate and business objectives;
  • High degree of enterprise thinking and achievement oriented;
  • Creative approach, rapid, flexible and decision making excellent communications and possessing outstanding presentation skills: capable of presenting ideas and data clearly to various audiences;
  • Networker;
  • Fluency in English (written and spoken). Fluency in other languages is an additional asset.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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