Title:
Clinical Development Director
Company: Ipsen Biopharm Ltd
Job Description:
The Clinical Development Director (CDD) is part of the Global Oncology Therapeutic Area team and Tovorafenib Global Asset team responsible and accountable for the development of the Clinical Development Plan (CDP) and the clinical aspects of the Integrated Development Commercialization Plan (IDCP) of Ipsen's new products in oncology under the direction of the VP, Clinical Development Oncology and in collaboration with the Tovorafenib Asset Lead. It leads the Global Development Team, working in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly developed within the asset team.
This position: Works closely with the global asset team cross-functionally: Early Development, Regulatory Affairs, Drug Safety, Medical Affairs, and Commercial Franchise Oncology in providing clinical support for the drug development program. Delivers high-quality scientific input and clinical interpretation on specific product data in fulfillment of the development business objectives for registration. Provides pivotal clinical input to Ipsen's individual oncology drugs, including but not limited to recently acquired assets, and supports regional and/or global drug development. Ensures 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. Advises the Vice President R&D Oncology and Tovorafenib Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions. Main Responsibilities / Job Expectations
Main Tasks Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%) Support in all medical, scientific, and clinical matters for Project Teams and drug development programs from lead compound identification to product registration and launch. 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, and Clinical Study Reports, with the support of other R&D functions and in line with IDP. Ensure execution of CDP and establish cross-functional alignment to support its execution where necessary. 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. Work on complex issues where analysis of situations or data requires in-depth knowledge of relevant programs and therapeutic area. 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 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 significant matters. Support the conduct of clinical trials as part of the Clinical Study Team and interface with medical CRO representatives. Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IDP. 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, representing Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conferences, or alike. Core Remit of Activities External to Therapeutic Area Development (approx. 35%) Proactively liaise with early development to ensure scientific and medical integrity of IDP, TPP, etc. Participate in competitive intelligence and/or other market/industry assessment activities and projects within the oncology area as appropriate. Liaise with key internal experts as required to support pre-clinical programs and Project Teams for efficient development of new chemical entities. Liaise with Early 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 a medical expert with External Innovation and business development teams to optimize 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. Assume tasks within the context of team performance and project progress in an objective-driven, solution-oriented manner with an overall can-do attitude. Be a proactive member and contributor to Ipsen's medical community. Knowledge, Abilities & Experience
Education / Certifications: Medical Doctor (MD) Knowledge & Experience: Minimum 10 years' proven experience in the oncology development area (from pre-clinical to global registration). Industry experience is an asset. Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge; and a track record of successful publications. Substantial experience in pharmaceutical drug development and, in an industry context, a track record of global clinical trials management and registration. 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 (beyond one's 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, and interpersonal communication skills. 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. #J-18808-Ljbffr
Company: Ipsen Biopharm Ltd
Job Description:
The Clinical Development Director (CDD) is part of the Global Oncology Therapeutic Area team and Tovorafenib Global Asset team responsible and accountable for the development of the Clinical Development Plan (CDP) and the clinical aspects of the Integrated Development Commercialization Plan (IDCP) of Ipsen's new products in oncology under the direction of the VP, Clinical Development Oncology and in collaboration with the Tovorafenib Asset Lead. It leads the Global Development Team, working in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly developed within the asset team.
This position: Works closely with the global asset team cross-functionally: Early Development, Regulatory Affairs, Drug Safety, Medical Affairs, and Commercial Franchise Oncology in providing clinical support for the drug development program. Delivers high-quality scientific input and clinical interpretation on specific product data in fulfillment of the development business objectives for registration. Provides pivotal clinical input to Ipsen's individual oncology drugs, including but not limited to recently acquired assets, and supports regional and/or global drug development. Ensures 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. Advises the Vice President R&D Oncology and Tovorafenib Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions. Main Responsibilities / Job Expectations
Main Tasks Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%) Support in all medical, scientific, and clinical matters for Project Teams and drug development programs from lead compound identification to product registration and launch. 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, and Clinical Study Reports, with the support of other R&D functions and in line with IDP. Ensure execution of CDP and establish cross-functional alignment to support its execution where necessary. 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. Work on complex issues where analysis of situations or data requires in-depth knowledge of relevant programs and therapeutic area. 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 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 significant matters. Support the conduct of clinical trials as part of the Clinical Study Team and interface with medical CRO representatives. Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IDP. 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, representing Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conferences, or alike. Core Remit of Activities External to Therapeutic Area Development (approx. 35%) Proactively liaise with early development to ensure scientific and medical integrity of IDP, TPP, etc. Participate in competitive intelligence and/or other market/industry assessment activities and projects within the oncology area as appropriate. Liaise with key internal experts as required to support pre-clinical programs and Project Teams for efficient development of new chemical entities. Liaise with Early 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 a medical expert with External Innovation and business development teams to optimize 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. Assume tasks within the context of team performance and project progress in an objective-driven, solution-oriented manner with an overall can-do attitude. Be a proactive member and contributor to Ipsen's medical community. Knowledge, Abilities & Experience
Education / Certifications: Medical Doctor (MD) Knowledge & Experience: Minimum 10 years' proven experience in the oncology development area (from pre-clinical to global registration). Industry experience is an asset. Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge; and a track record of successful publications. Substantial experience in pharmaceutical drug development and, in an industry context, a track record of global clinical trials management and registration. 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 (beyond one's 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, and interpersonal communication skills. 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. #J-18808-Ljbffr
