We bring breakthrough pioneering therapies to patient with life threatening diseases
Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based product candidates and utilizes its expertise in cell engineering to target cancer. Our ambition is to develop a unique immunotherapeutic approach to offer new treatment options to cancer patients. Our CAR-T cell platform has the potential to treat a broad range of solid and hematologic tumors. The company’s lead clinical candidate, CYAD-01, an autologous NKG2D-based CAR-T therapy, is currently being evaluated in several Phase 1 clinical trials to assess safety and clinical activity for the treatment of hematological malignancies, such as acute myeloid leukemia, and solid cancers, such as metastatic colorectal cancer. Celyad is also developing CYAD-101, an investigational, non-gene edited, allogeneic (donor derived) NKG2D-based CAR-T therapy, which is currently being evaluated in a Phase 1 trial for the treatment of patients with metastatic colorectal cancer. NKG2D-based CAR-Ts have the potential to target and destroy 80% of cancer types.
Based in Europe and in the U.S., Celyad offers a nice working environment as well as the opportunity to interact with colleagues and stakeholders involved at each step of the product development. Our Company surrounds itself with the best industrial and academic partners to explore the full potential of its technological platform. Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and New York, NY. We are a public company listed on the Euronext Brussels and Euronext Paris exchanges, as well as on the Nasdaq Global Market (CYAD).
Celyad is looking for an enthusiastic:
Medical Director Hematology (M/F)
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.
A. 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.
B. 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
C. Global Responsibilities
1. 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
2. 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
• 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
- Fluency in English (written and spoken). Fluency in other languages is an additional asset