Sr. Clinical Development Director, Oncology New Products & Innovation

Job Title: Senior Director, Early clinical development Oncology Division / Function: Oncology Therapeutic Area Manager (Name, Job Title): Senior Vice President, Global Head Oncology Therapeutic Area Location: Ipsen R&D hubs : France & UK Summary / purpose of the position Senior Director, Early clinical development Oncology is part of the Oncology Therapeutic Area Leadership Team, responsible and accountable of all the early clinical program portfolio ( from IND till phase II) including the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen’s new products in oncology aligned with the Oncology Therapeutic Area strategy and in collaboration with Early development pre-clinical team . The position leads the Global Development Team(s) for the Assets 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 an 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. Works closely in partnership with Global Early pre-clinical teams, Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing clinical support for drug development programs. Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration. 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. Ensures from a medical perspective compliance with GCP, ethical, scientific, and medical guidelines and statutory principles throughout all clinical development activities. Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results. Effectively manages relationships in a cross functional and matrix environment with internal and external stakeholders. Participates, as required, in Business Development activities including providing expert clinical evaluation of asset data and developing relevant Clinical Development Plans. Main responsibilities / job expectations Main Responsibilities Main Tasks Support in all clinical , scientific, strategic, and clinical matters both Project Teams and drug development programs from lead compound identification to phase II Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%) 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 clinical aspects of IDP; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP. Make final decisions on clinical and medical matters for clinical study teams, supporting clinical operations to achieve clinical team objectives and execution of clinical programs. Act as a resource for clinical study teams and relevant project teams, contribute to the development of key documents (for example TPP, IDP, KPIs). Ensure budgets and schedules meet corporate requirements. Regularly interact with major internal and external stakeholders (KOLs Investigators, experts). Interactions frequently involve utilization of key communication skills and medical expertise, such as negotiating with customers or management or influencing senior level leaders within and outside of Research and Development regarding matters of significance to the organization. Act as a subject matter expert for internal resources. 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 represent Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike. Core Remit of Activities External to Therapeutic Area Development (approx. 35%) Proactively liaise with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc… As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects within the oncology area. 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 Early pre-clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies). Liaise as medical expert with External Innovation and business development teams to optimize the due diligence activities. General duties and responsibilities 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 progress in an objective-driven, solution and results oriented manner with an overall can-do attitude. Be a proactive member and contributor to Ipsen’s medical community. Knowledge, abilities & experience Education / Certifications: MD required; MD PhD preferred. Board-certification (board-equivalence) in Hematology and/or Medical Oncology or training in hematology and/or oncology is highly desirable. Knowledge & Experience: Minimum 10 years proven experience in oncology/hematology. Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge; and track record of successful publications Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management Previous experience directly and independently leading projects and/or a team of professionals Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond ones’ own function) Key Technical Competencies Required Objective-driven, solution and results oriented, with a solid sense of urgency. Excels in working in matrix organizations and project teams. Excellent priority setting, time management and organizational skills Excellent verbal, written, interpersonal communication skills #J-18808-Ljbffr