Clinical Development Director

2 settimane fa


Siena, Italia GSK A tempo pieno

**Site Name**: GSK Tres Cantos, Madrid, Italy - Siena, UK - Hertfordshire - Stevenage, UK - London - Brentford

**Posted Date**: Jun 12 2023

Our commitment to Global Health (GH) is an important priority for GSK. The purpose of Global Health is to unite science, talent and technology to get ahead of disease together by changing the trajectory of high burden infectious diseases that disproportionately affect the underserved in lower-income countries. Within Global Health we seek to progress our pipeline to prevent and treat priority infectious disease particularly those with AMR potential, expand sustainable access to GH innovations and the GSK portfolio and pipeline, and to strengthen health systems and improve pandemic preparedness.

**Overview**:
This position is in the Global Health Medicines R&D (GHMRD) clinical development group, which focuses on drug development and clinical development of anti-infectives for diseases that affect populations in lower income countries, including malaria and TB.

The clinical team supports the drug discovery work of the GHMRD research unit, based in Tres Cantos, Spain, and in collaboration with external non-governmental organisation (NGO) partners and academics. The team also works closely with clinical operations, statistics, regulatory, clinical pharmacology modelling & simulation, safety and non-clinical groups, to design and execute drug and clinical development programmes for medicines in development, and with GH colleagues who provide access insights and analytics to inform prioritisation, investment, partnership, and development pathways.

**The Role**:
The main focus of this role will be to provide drug and clinical development expertise for the GSK portfolio of anti-infective therapies for Global Health. This will involve close working relationships with colleagues within Global Health, safety, clinical operations, medical affairs and regulatory, to design and execute drug development programmes for medicines in development.

This role will also require close interaction with the drug discovery research groups in Global Health, to provide development and clinical insights and to develop and execute drug and clinical development strategies around a disease and/or drug compound. This may include the development of novel tools and methodologies.

An underpinning strategy of the Global Health is to find specialist partners at or before proof of concept to help bring our medicines to patients. As such strong collaboration and regular interaction with product development partners, NGOs and funders is a requirement. This would include consultative input and oversight of development partners acting as study sponsors, and contribution to and/or leadership of partner-led development.

The position holder will be expected to lead the development and delivery of drug development strategy.

**Role responsibilities**:

- Support may be required for the business development team in reviewing licensing/ partnering opportunities.
- Presentations within and external to GSK will be required.
- Develop and maintain a high level of current knowledge in the therapeutic area.
- Serve as an active matrix team leader and/or member by providing guidance and direction to peer physicians and scientists to ensure the successful achievement of the unit's goals and milestones.
- Actively participate in the development of others within the organisation, provide guidance and coaching to team members.

**_ Why you?_**:
**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Good appreciation of the drug development process and clinical trials
- Demonstrated ability to learn new aspects of the therapeutic area through reading, conference attendance and engagement with experts
- Ability to travel up to 20% of the time
- Ability to operate effectively across functions and geographic interfaces
- Ability to influence and lead in a matrix organisation, including external partners
- Flexible, focused, enthusiastic, and able to identify opportunities
- Able to operate in a complex organisational environment, and willing to challenge the status quo
- Comfortable with being personally accountable and capable of arguing own case in the best interest of patients.
- Strong oral & written communications skills
- Comfortable engaging and communicating with external opinion Leaders
- Visible and accountable and with an open style of interaction

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Experience of design and conduct of First Time in Human and Proof of Concept Studies
- Track record of managing collaborations with external stakeholders Experience in Infectious Diseases, particularly diseases disproportionately impacting patients in low resource settings

**_ Why GSK?_**:
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease to



  • Siena, Italia GSK A tempo pieno

    **Site Name**: USA - Massachusetts - Cambridge, Belgium-Wavre, GSK House, Italy - Siena, Rockville Vaccines **Posted Date**: Mar 4 2024 **Position Summary** The **Senior Director, Clinical Project Lead (CPL)** leads the Clinical Development Program(s) for one asset or a portfolio of assets. The CPL provides integrated and innovative clinical development...


  • 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...


  • Siena, Toscana, Italia GSK A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, Bengaluru Luxor North Tower, Poznan Business Garden Pastelowa, UK - London - BrentfordPosted Date: May Clinical Operations Asset Lead - VaccinesThe role:The Clinical Operations Asset Lead Role is a highly visible and critical role within Global Clinical Operations and Asset Development Teams. This role requires...


  • Siena, Italia CSL A tempo pieno

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and...


  • Siena, Italia CSL A tempo pieno

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Cambridge Binney Street, Belgium-Rixensart, Italy - Siena **Posted Date**: Mar 18 2024 **_ Join our challenge to get ahead of disease together!_** **_ Type of contract_**_:_ _Permanent_ **_ Location_**_:_ _Rixensart_, Siena, US sites will be considered_ **Job Purpose** - Defines the product technical development strategy in collaboration...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, UK - London - Brentford, USA - Massachusetts - Waltham **Posted Date**: May 27 2024 **Job purpose**: As the Director Vaccines Development CMC you, - Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliverables for a specific asset of vaccine development products, including...


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

    Job purpose: As the Director Vaccines Development CMC you, Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliverables for a specific asset of vaccine development products, including in-licensed assets, through to commercial approval Manage a team of CMC regulatory scientists responsible for providing CMC...


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

    Job purpose: As the Director Vaccines Development CMC you, Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliverables for a specific asset of vaccine development products, including in-licensed assets, through to commercial approval Manage a team of CMC regulatory scientists responsible for providing CMC...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - London - Brentford **Posted Date**: May 10 2023 **Director/Senior Director Global Medical Affairs Lead - Scientific Affairs & Public Health, Global Health Access**: Are you motivated by GSK’s Global Health ambition to reduce health inequalities by changing the trajectory of high...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena, Warsaw **Posted Date**: Jun 7 2023 **SERM Associate Medical Director** We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Warsaw, Belgium-Wavre, Italy - Siena **Posted Date**: Jan 13 2023 Study Delivery Lead - This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. **Key responsibilities**: - Accountable and responsible for delivery of...


  • Siena, Toscana, Italia GSK A tempo pieno

    Site Name: Warsaw, Belgium-Wavre, Italy - SienaPosted Date: Jan Study Delivery Lead - This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams.Key responsibilities: Accountable and responsible for delivery of study as defined by protocol and...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Bengaluru Luxor North Tower, Italy - Siena, UK - London - Brentford, USA - Pennsylvania - Upper Providence **Posted Date**: Mar 13 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...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena, Cambridge Park Drive, GSK House, Rockville Vaccines, Wavre **Posted Date**: Feb 26 2024 **Position summary** The **Executive Director, Safety Evaluation & Risk Management (SERM) Head** is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of...


  • 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...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena **Posted Date**: Jul 3 2023 **Head of Bacterial Projects**: Reporting to the VP, Global Health R&D Vaccines Head and GVGH Institute Director, the Head of Bacterial Projects will provide strong leadership for the discovery and development portfolio for GVGH to identify and advance new bacterial vaccine assets to build and...


  • Siena, Italia 12371 GSK Vaccines S.r.l. A tempo pieno

    Position summary The Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies. Competencies ...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Cambridge MA, GSK House, Munich, Netherlands - Amsterdam, Rockville Vaccines, Siena, Stevenage, USA - Pennsylvania - Upper Providence **Posted Date**: Feb 16 2023 **About the team**: GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders,...


  • Siena, Toscana, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Cambridge Park Drive, GSK House, Rockville Vaccines, Warsaw Cirrus, WavrePosted Date: May Position summaryThe Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical...