Clinical Development Director, Early Clinical Development, Oncology

Job title:

Clinical Development Director, Early Clinical Development, Oncology

Company

Ipsen

Job description

Title: Clinical Development Director, Early Clinical Development, OncologyCompany: Ipsen Biopharm LtdJob Description:Job Title: Clinical Development Director, Early Clinical Development, OncologyDivision / Function: R&D Oncology Therapeutic AreaManager (Name, Job Title): Vice president, Early Clinical Development OncologyLocation: EuropeSummary / purpose of the positionThe Clinical Development director, Early Clinical Development, is part of the Global Oncology team, responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen’s new products in oncology as directed by the VP Global Early Development, aligned with the Oncology Therapeutic Area strategy and in collaboration with the global Asset Lead. The position leads the Global Development Team for the Asset 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 Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical 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 expectationsMain ResponsibilitiesMain Tasks

• Support in all medical, scientific, strategic, and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch

• 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 medical 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.
• 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.
• Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials.
• 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 Product Profile (TPP) and IDP.
• 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 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 & experienceEducation / 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 5 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)

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.

Expected salary

Location

London

Job date

Fri, 27 Sep 2024 23:16:22 GMT

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