clinical trial jobs

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 development of the Clinical Development Plan (CDP) and 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 Tovorafenib Asset Lead . It leads the Global Development Team Works 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, 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 fulfilment of the development business objectives for registration.
• Provide pivotal clinical 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 clinical 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.
• Advises 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 Responsibilities

Main Tasks

• Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%)

• Support in all medical, scientific and clinical matters both 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, Clinical Study Report, with the support of other R&D functions and in line with 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.
• Work on complex issues where analysis of situations or data requires an 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 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
• Support the conduct of clinical trials as part of the Clinical Study Team and interfacing 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 and to 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 early development 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 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:

• Medical Doctor (MD)

Knowledge & Experience:

• Minimum 10 years’ proven experience in oncology development area (from pre-clinical to global registration).
• Industry experience an asset.
• 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 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 (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 organisational skills
• Excellent verbal, written, interpersonal communication skills