Medical Director Hematology

Medical Director Hematology

Celyad

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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Belgium     Clinical Research     Manager and Executive     Medical     Medical Advisor     Pharmacovigilance and Medical Information     Physician     Celyad    

© 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

Newsletter | Recruit | Advertise | Privacy | Contact Us

© 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

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies