Global Therapeutic Area Clinical Development

vor 4 Wochen

Basel, Schweiz Abbott Laboratories Vollzeit

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott Established Pharma Division (EPD) is looking for a

**Global Therapeutic Area Clinical Development Director**

to be based in Allschwil
- Basel, Switzerland

**Primary Job Function**:
The Global TA Clinical Director establishes the Clinical Development Strategy and Clinical Program design for global products within the assigned Therapeutic Area, he/she is accountable for the delivery against agreed goals and objectives of approved clinical programs.

**Core Job Responsibilities**:
**Clinical Strategy Lead for assigned Therapeutic Area’s**
- Builds, maintains and makes available expert clinical integrated compound and Therapeutic Area knowledge.
- As a standing member of Need State Teams supports building the Therapeutic Area strategy and tactical plans, including future product portfolio development.
- Stays abreast with medical/scientific knowledge, competitor landscape, current business conditions and clinical practices within the assigned Therapeutic Area to continuously improve innovation, speed, quality and productivity in Clinical design and approach to drive innovation outcomes
- Builds and maintains network of external clinical experts including Subject Matter Experts and Key Opinion Leaders
- Lead clinical evaluation of new development opportunities, designing innovative, insight driven (internal and external), scientifically sound, risk-based and compliant global clinical development programs based on the agreed target product profile, aligned with EPD’s strategy and business environment
- Defines operational execution strategies including timelines and cost, in close consultation with clinical development functions ie Clinical Science, Biometrics and Clinical Operations.
- Seek endorsement of proposed clinical strategy and it’s business rationale with cross-functional stakeholders including regional medical/clinical functions when appropriate. Represent the clinical development function in various internal governance forums
- Participate in due diligences for new licensing / co-development opportunities

**Clinical Program execution**:

- Accountable for the design and operational delivery of the approved clinical programs according to the agreed budget and timeline and in compliance with applicable laws, regulations, ICH-GCP guidelines, and Abbott policies, in close collaboration with responsible Clinical Program Manager and assigned Clinical Study Team(s)
- Takes ownership for clinical study medical/safety aspects and assures continuous risk-benefit assessments for patients and healthy volunteers participating in Abbott sponsored clinical studies
- Proactively identifies and monitors risks (compliance, business, patient safety, medical) throughout the clinical program life cycle and ensures mitigation strategies are in place and executed on.
- As a core member of the Clinical Operations Governance Board ensure new risk/issues are timely identified, assessed and escalated to stakeholders, including I&D Leadership team if required.
- Leads the cross-functional Scientific Review Forum responsible for the review and approval of clinical trial related deliverables, including (but not limited to) clinical study protocols, safety review plans, clinical study reports, investigator brochure, clinical sections of regulatory submissions, response to inquiries from regulatory agencies and ethics committees
- Lead final results analysis, interpretation, integration and dissemination to internal (project teams, senior management, governance forums) and external stakeholders (regulatory bodies, investigators), including authoring of scientific publications

**Pharmacovigilance activities**:

- Core member of the Product Safety Team for assigned products
- Review of Pharmacovigilance deliverables e.g. Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), Development Safety Update Report (DSUR) Addenda to Clinical overviews (ACO), ect

**Regulatory Affairs activities**:

- Responsible for the development and maintenance of clinical sections of regulatory submissions
- Lead response to clinically relevant inquiries / deficiency letters from the Health Authorities
- Oversee Labeling Subteam Team(LST) deliverables, provide clinical evaluation and propose scientific strategies with regards to maintenance of CCDS, Master SmPC and any changes required to that

**Position Accountability/Scope**:

- Accountable for the clinical development strategy for assigned globally supported Therapeutic Area
- Accountable for the design and delivery and reporting/publication of clinical programs in accordance with international medical/scientific and quality s

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