Clinical Science Lead

2 settimane fa

Siena, Italia GSK A tempo pieno

**Site Name**: USA - Maryland - Rockville, Belgium-Wavre, GSK House, Italy - Siena, Netherlands - Amsterdam

**Posted Date**: Jul 3 2023

Clinical Science Lead (CSL)

**Job Purpose**:
To conduct Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK standard operating procedures (SOP).

**Key Responsibilities**:
**Participates in Clinical Development activities for a study or a number of studies within a specific program or group of related programs.**
- Design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability to Clinical Project Lead (CPL).
- Ultimate accountable end to end for any step of a clinical study, clinical trial synopses and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report
- Bear primary responsibility and accountability for scientific and medical quality of clinical studies.
- Assure that results meet the highest standards of quality and ethical conduct.
- Support to Independent Data Monitoring Committee (IDMC).
- Participate as core member to clinical study teams
- Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
- Support where applicable the Clinical Project Lead in representing GSK in meetings with health authorities and the scientific community, network with thought leaders and international agencies as needed.

**Serves as a scientific and management reference for the project (internally/externally)**
- Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
- Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
- Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
- Liaise with Safety to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and other aggregated periodic safety reports and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with Safety analyse safety and potential signals and escalate accordingly.
- Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
- Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
- Supports internal process improvement activities and initiatives.

**As a member of the Clinical Project Team, always actively participate and engage within the project matrix.**
- Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
- May be delegated by Clinical Project Lead or Senior Clinical Sciences Lead to lead the Clinical Project Team.

**Actively participate in preparing the clinical portion of the regulatory files and the registration process**
- Contribute to development of clinical section of regulatory files, including labelling.

**Provides support to Marketing/Business Development throughout product life cycle**
- Provide medical support to Marketing/Business Development in order to achieve Company’s objectives.

**Show active follow-up the product-related Environment**
- Collect scientific information and review GSK Vaccines project related documents and publications.

**Requirements**:
Minimum Level of Education Required:

- MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.

Preferred Level of Education:

- MD or PhD specializing in the field of paediatrics, obstetrics and gynaecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset. Minimum 1 year industry experience or minimum 5 years experience working in a scientific or medical institution (if not an MD, prior experience as Principal Investigator, Medical Monitor or commensurate to Clinical Research Scientist position)
- Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
- Wo

  • Clinical Science Lead

    4 settimane fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, GSK House, Rockville Vaccines, Siena **Posted Date**: Feb 22 2023 **Job Purpose**: To conduct Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide...

  • Clinical Operation Asset Lead

    4 settimane fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Belgium-Rixensart, GSK House, Italy - Siena **Posted Date**: May 19 2023 **Type of contract**: Permanent **Location**: Belgium: Wavre, or Rixensart United Kingdom: GSK House* Italy (Siena) **_ Join our challenge to get ahead of disease together!_**: **Your responsibilities**: The Clinical Operations Lead (COAL) will be...

  • Clinical Quality Assurance Manager

    1 mese fa

    Siena, Italia Philogen A tempo pieno

    **Location: Siena - Italy** *** **Department: Clinical, QA** *** Philogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a **“Clinical Quality Assurance Manager (GCP)”**. The position will be responsible to assess compliance with...

  • Associate Director, Medical Writing Asset Lead

    7 giorni fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, Mississauga, UK - Hertfordshire - Stevenage **Posted Date**: Jun 9 2023 **Job purpose**: **Your responsibilities**: **Leadership and Expertise**: - Lead one or more assets and serve as a medical writing point of contact for this/these assets. Support prioritising workload across an asset (s)to deliver MW...

  • Sr Manager, Global Regulatory Affairs

    4 settimane fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena, Philadelphia Navy Yard, UK - United Kingdom **Posted Date**: Jul 12 2023 Are you interested in a highly visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Manager could be...

  • Business Development Lead

    4 giorni fa

    Siena, Italia 1849 GlaxoSmithKline Biologicals S.A. A tempo pieno

    Business Development Lead– Global Health Job Purpose This role is critical to support senior management as well as Gov Affairs and Global functions by providing expert BD support and leadership on a range of activities covering the strategic design of Global Health (GH) partnerships based on the needs of the business and its commercial. Access,...

  • Business Development Lead

    1 mese fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Belgium, Italy - Siena, Spain - Madrid, UK - Greater London **Posted Date**: Apr 16 2024 **Business Development Lead - Global Health** **Job Purpose** This role is critical to support senior management as well as Gov Affairs and Global functions by providing expert BD support and leadership on a range of activities covering...

  • Regulatory Affairs Manager

    4 settimane fa

    Siena, Italia Philogen A tempo pieno

    Philogen would like to hire a Regulatory Affairs Manager who will report to the Management and will provide support in formulating and implementing regulatory strategies for the development of Company Products in close collaboration with other functions in the Clinical Department. In particular, the selected candidate will carry out the following tasks: Lead...

  • Head Vaccine Toxicology

    4 settimane fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: USA - Maryland - Rockville, Belgium-Rixensart, Italy - Siena **Posted Date**: Jan 27 2023 **Head Vaccine Toxicology**: - Are you looking for an opportunity to design and lead Toxicology strategies and programs on new drug substances? If so, this is the job for you._ **Job Purpose** As Toxicology Director you will provide specialized...

  • Serm Principal Scientist

    4 settimane fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena **Posted Date**: Mar 23 2023 **SERM Principal Scientist** Provides scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety...

  • Senior Brand Manager; Commercial Italy

    1 mese fa

    Siena, Italia CSL A tempo pieno

    The Senior Brand Manager designs, develops, and implements an effective brand strategy to drive the successful launches of new vaccines in Italy. He/she is responsible for developing a pre-marketing and launch strategy for new vaccines in close collaboration with Head of Marketing and the broader cross-functional team. He/she develops a highly impactful...

  • Senior Brand Manager; Commercial Italy

    5 giorni fa

    siena, Italia CSL Seqirus A tempo pieno

    The Senior Brand Manager designs, develops, and implements an effective brand strategy to drive the successful launches of new vaccines in Italy. He/she is responsible for developing a pre-marketing and launch strategy for new vaccines in close collaboration with Head of Marketing and the broader cross-functional team. He/she develops a highly impactful...

  • Senior Brand Manager; Commercial Italy

    4 giorni fa

    Siena, Italia CSL Plasma Inc. A tempo pieno

    Senior Brand Manager; Commercial Italy page is loadedSenior Brand Manager; Commercial ItalyApplylocationsSeqirus Italy - Sienatime typeFull timeposted onPosted 10 Days Agojob requisition idR-226451The Senior Brand Manager designs, develops, and implements an effective brand strategy to drive the successful launches of new vaccines in Italy. He/she is...

  • Senior Brand Manager; Commercial Italy

    1 mese fa

    Siena (SI), Italia CSL Seqirus A tempo pieno

    The Senior Brand Manager designs, develops, and implements an effective brand strategy to drive the successful launches of new vaccines in Italy. He/she is responsible for developing a pre-marketing and launch strategy for new vaccines in close collaboration with Head of Marketing and the broader cross-functional team. He/she develops a highly impactful...

  • Senior Brand Manager; Commercial Italy

    4 settimane fa

    Siena (SI), Italia CSL Seqirus A tempo pieno

    The Senior Brand Manager designs, develops, and implements an effective brand strategy to drive the successful launches of new vaccines in Italy. He/she is responsible for developing a pre-marketing and launch strategy for new vaccines in close collaboration with Head of Marketing and the broader cross-functional team. He/she develops a highly impactful...

  • Head Vaccines Cmc Project

    1 settimana fa

    Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Belgium-Rixensart, Italy - Siena, UK - London - Brentford, USA - Maryland - Rockville Posted Date: Apr 30 2024 Job purpose: As the Head of Vaccines (Vx) CMC Project and Portfolio Management you are accountable for all operational aspects of Vx CMC project and portfolio delivery internally and externally including budget, risk, resourcing,...

  • Head Vaccines CMC Project

    1 settimana fa

    Siena (SI), Italia GlaxoSmithKline A tempo pieno

    Site Name: Belgium-Rixensart, Italy - Siena, UK - London - Brentford, USA - Maryland - Rockville Posted Date: Apr 30 2024 Job purpose: As the Head of Vaccines (Vx) CMC Project and Portfolio Management you are accountable for all operational aspects of Vx CMC project and portfolio delivery internally and externally including budget, risk, resourcing,...