Performance Profile. Clinical Study Physician. 1

Transcription

1 Performance Profile Clinical Study Physician 1

2 Role: 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. Position in the organization: Reports to the Immuno-Onco Franchise Leader who is based in Belgium. Position based in the USA, Boston area. I. Expected results A. Quantitative 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. 2

3 B. Qualitative Quality of the medical advice Scientific and medical quality of all clinical trial documents (including the Investigator s Brochure and the CSR) Interface with the Program Director & Franchise leader (to ensure milestone realization and resource optimization) Recognition of the company and the products within the scientific and medical community II. Tasks / Agenda 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 (INDs, NDAs, annual reports); 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, network 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 3

4 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 III. Profile A. Hard skills Medical degree and experience as a physician or academic Therapeutic area expertise, in particular Oncology. Specialty training in Oncology is highly desirable. At least 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 highquality 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 B. Soft skills 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 4

5 High degree of enterprise thinking and achievement oriented Creative approach, rapid, flexible and decision making Excellent communication and presentation skills : be 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 5