Title:
Senior Medical Development Director, Oncology
Company: Ipsen Biopharm Ltd
Job Description:
The Senior Clinical Development Director (SrMDD) position: Recognized as influential leader, the Senior Medical Development Director (SrMDD), develops, proposes, and influences asset teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience. Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration. Leads the Clinical Development sub-team of the allocated asset team, working in partnership with Regulatory Affairs and Global Patient Safety and other relevant functions to define the optimal development approach for the asset and indication. Provides medical leadership for asset development programs. 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. Advises Asset Lead (AL) on critical issues deserving immediate attention and escalation, proposing actionable solutions. Acts as an independent and reliable resource to the Asset Lead, assisting in driving strategy and execution. Manages effectively relationships in a cross-functional and matrix environment. May provide pivotal medical input to support regional and/or global asset development. Main Duties Support in all medical, scientific, strategic and clinical matters both Asset Team for drug development programs from lead compound identification to product registration and launch. Participate with AL and other senior managers in establishing strategic plans and objectives. 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, RFIs/RFPs. Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; 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 (including oversight of contracted Medical Monitors depending on the respective outsourcing model of clinical trials) 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. Proactively and reactively inform, as appropriate and legally required, Global Patient Safety, Asset Team, Clinical Study Team(s) 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 and the Asset Team at investigator meetings, expert panels, advisory boards or alike. May work in a joint team setting with partner companies where applicable to the Asset. Provide upon request support to Due Diligence Teams (together with Business Development and Scientific Affairs). 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. Education & Experience Medical school (minimum, MD title) or equivalent academic education in life sciences (minimum, PharmD, PhD title or equivalent). 5-10 years Industry experience. Preferably a gastroenterologist, hepatologist or internist with experience in hepatic diseases. Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications (preferably with translational medicine experience) in Internal Medicine, or any therapeutic area in Rare Diseases. Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management. Rare disease experience is preferable. Real world evidence or data generation experience preferable. 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 one's own function). Skills and Competencies 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 organisational skills. Excellent verbal, written, interpersonal communication skills. Advanced presentation skills and knowledgeable in IT tools for word processing and presentations. Specific Requirements Ability and willingness to assume domestic and international travel. Ability and willingness to work in a global matrix organisation and in cross-functional teams. Languages Fluency in English is a must; any other language is an asset. IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
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Company: Ipsen Biopharm Ltd
Job Description:
The Senior Clinical Development Director (SrMDD) position: Recognized as influential leader, the Senior Medical Development Director (SrMDD), develops, proposes, and influences asset teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience. Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration. Leads the Clinical Development sub-team of the allocated asset team, working in partnership with Regulatory Affairs and Global Patient Safety and other relevant functions to define the optimal development approach for the asset and indication. Provides medical leadership for asset development programs. 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. Advises Asset Lead (AL) on critical issues deserving immediate attention and escalation, proposing actionable solutions. Acts as an independent and reliable resource to the Asset Lead, assisting in driving strategy and execution. Manages effectively relationships in a cross-functional and matrix environment. May provide pivotal medical input to support regional and/or global asset development. Main Duties Support in all medical, scientific, strategic and clinical matters both Asset Team for drug development programs from lead compound identification to product registration and launch. Participate with AL and other senior managers in establishing strategic plans and objectives. 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, RFIs/RFPs. Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; 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 (including oversight of contracted Medical Monitors depending on the respective outsourcing model of clinical trials) 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. Proactively and reactively inform, as appropriate and legally required, Global Patient Safety, Asset Team, Clinical Study Team(s) 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 and the Asset Team at investigator meetings, expert panels, advisory boards or alike. May work in a joint team setting with partner companies where applicable to the Asset. Provide upon request support to Due Diligence Teams (together with Business Development and Scientific Affairs). 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. Education & Experience Medical school (minimum, MD title) or equivalent academic education in life sciences (minimum, PharmD, PhD title or equivalent). 5-10 years Industry experience. Preferably a gastroenterologist, hepatologist or internist with experience in hepatic diseases. Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications (preferably with translational medicine experience) in Internal Medicine, or any therapeutic area in Rare Diseases. Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management. Rare disease experience is preferable. Real world evidence or data generation experience preferable. 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 one's own function). Skills and Competencies 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 organisational skills. Excellent verbal, written, interpersonal communication skills. Advanced presentation skills and knowledgeable in IT tools for word processing and presentations. Specific Requirements Ability and willingness to assume domestic and international travel. Ability and willingness to work in a global matrix organisation and in cross-functional teams. Languages Fluency in English is a must; any other language is an asset. IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
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