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Sr. Clinical Development Director
il y a 2 semaines
The Senior Medical Development Director oncology is part of the Global Asset team responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP)) as directed by the Vice-President Oncology Therapeutic Area Head in collaboration with the Asset Lead.It leads the Global Development Team and works in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly developed within the asset team
This position:
- Recognized as influential leader, develops, proposes, and influences project and R&D teams on new uses for compounds currently in proof of concept and/or life cycle management.
- Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
- Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities
- Works closely in partnership with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical support for drug development programs
- Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results.
- Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders
- Advises Vice President R&D oncology and Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions.
- May provide pivotal medical input to Ipsen’s individual oncology drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development
**Main responsibilities and tasks**
**Main Tasks**
- Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs.
- Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP
- Assume ownership of CDP and medical aspects of IDP; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP
- Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials
- Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of TPP and IDP
- Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with medical CRO representatives
- Support as clinical referent the global registration of the oncology drug in Ipsen territories
- Proactively and reactively inform, as appropriate and legally required, Global Drug Safety, Project Team, Clinical Study Team and functional leads of:
- Any safety signals emerging from clinical trials
- Any emerging medical risks and opportunities with an impact on timely and successful completion of development programs
- Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
- Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike
- Support the clinical evaluation of business development opportunities
- Liaise with key stakeholder for asset teams to share knowledge and experience
- Liaise with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities
- Liaise with Late Drug Development platform and Franchises to both integrate business needs into IDP and to report progress of development programs with focus on patient safety and potential business risks and opportunities
- Comply with Ipsen’s SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research
- Develop and maintain state of the art scientific, medical and managerial knowledge by:
- Establishing and maintaining an external professional network
- Reading pertinent scientific and medical publications
- Attending pertinent training courses, workshops, conferences etc.
- Commit to support transformation and change management of R&D division with a focus on high performance culture, data quality, timeliness and budget control accounts
- Assume tasks within the context of team performance and project pr
