Scientist - Medical Affairs Interventional Studies

il y a 4 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - New Oxford Street, USA - District of Columbia - Washington Dc, USA - Massachusetts - Waltham
**Posted Date**: Nov 14 2024

GSK is a global healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. We discover, develop, and deliver innovative medicines, vaccines, and consumer healthcare products, and we are dedicated to our mission of helping people around the world.

At GSK, we are dedicated to creating an inclusive and diverse workplace that reflects the communities we serve. We offer competitive compensation and benefits packages, opportunities for professional development, and a culture that values innovation, collaboration, and integrity.

The **Scienti**st**,** Interventional Studies **will oversee the execution of a program of sponsored clinical trials by the medical affairs organization (non-regulatory label directed programs). This role requires a manager with expertise in industry sponsored clinical research & global medical affairs and have good cross-functional team management. The scientist will ensure that all interventional studies under their scope are conducted to the highest standards of quality, ethics, and efficiency, utilizing the latest clinical trial innovations including digital health, driving forward GSK’s pipeline of innovative therapeutics. They will work in a matrix manner with the Global Medical Affairs therapy area teams, and the clinical operation & Biostatistics organization to execute the program of work.

**Key Responsibilities**:

- Operational Management:

- Oversee the operational aspects (delivered by clinical operations & Biostatistics) of medical affairs interventional studies, including planning, budgeting, resource allocation, and timeline management.
- Collaborate with cross-functional R&D teams to ensure seamless execution and delivery of clinical programs, as well as third party vendors.
- Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.
- Regulatory and Compliance:

- Ensure that all interventional studies are conducted in accordance with GCP, and other relevant regulatory guidelines.
- Maintain oversight of all regulatory submissions and interactions related to interventional studies.
- Ensure robust quality control and assurance processes are in place for all clinical trials.
- Stakeholder Engagement:

- Serve as the primary point of contact for internal and external stakeholders regarding interventional studies.
- Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution.
- Communicate study progress, challenges, and outcomes to senior leadership and other relevant stakeholders.
- Innovation and Continuous Improvement:

- Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies.
- Stay abreast of industry trends, emerging technologies, and new methodologies in clinical research.
- Promote a culture of continuous improvement within the interventional studies team.

**_ Why you?_**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent).
- Minimum of 10 years of experience in clinical research
- Proven track record of successful management of large-scale interventional clinical trials.
- In-depth knowledge of regulatory requirements and industry standards for clinical research, including being a medical monitor.

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Good leadership, communication, and interpersonal skills.
- Strong problem-solving abilities.
- Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where pe

  • Medical Reviewer Consultant

    Il y a 6 mois

    Wavre, Belgique Oxford Global Resources Temps plein

    **Medical Reviewer Consultant - Medical Affairs**: - Location: Wavre - Contact: Amandine Planche - Job type: Permanent - Contact phone: +32 10 68 53 34 - Industry: Pharmaceutical, Life Sciences, Education, Clinical Research Hybrid working opportunity : mix of home-working and on-site working at client's location (Wavre). As a Medical Writer, you'll join...

  • Director Medical Affairs Benelux

    il y a 1 mois

    Wavre, Belgique Abbott Laboratories Temps plein

    **Medical Manager, Abbott Diabetes Care (BENELUX)** **Location**: Headquarters in Belgium **Primary Function**: - Interact with key stakeholders in the medical community, providing training and scientific advice on Abbott Diabetes Care monitoring solutions. - Contribute to the design of local clinical trials, ensuring meaningful differentiation of Abbott...

  • Ta Head

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - New Oxford Street **Posted Date**: Sep 23 2024 GlaxoSmithKline (GSK) is a global healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. We discover, develop, and deliver innovative medicines, vaccines,...

  • Director, Global Real-world Evidence

    Il y a 2 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - New Oxford Street **Posted Date**: Oct 10 2024 For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market position. Specifically, evidence must be maintained throughout the product lifecycle as...

  • Independent Medical Reviewer Consultant

    Il y a 6 mois

    Wavre, Belgique Oxford Global Resources Temps plein

    **Independent Medical Reviewer Consultant - Medical Affairs**: - Location: Wavre - Contact: Amandine Planche - Job type: Permanent - Contact phone: +32 10 68 53 34 - Industry: Pharmaceutical, Life Sciences, Education, Clinical Research Hybrid working opportunity : mix of home-working and on-site working at client's location (Wavre). As an Independent...

  • Independent Medical Reviewer Consultant

    Il y a 6 mois

    Wavre, Belgique Oxford Global Resources Temps plein

    Location: Wavre - Contact: Amandine Planche - Job type: Permanent - Contact phone: +32 10 68 53 34 - Industry: Pharmaceutical, Life Sciences, Education, Clinical Research Hybrid working opportunity : mix of home-working and on-site working at client's location (Wavre). As an Independent Medical Writer, you'll join the Medical Strategy and Operations team,...

  • Medical Advsior

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: Warsaw Rzymowskiego 53, Belgium-Wavre, GSK House, Poznan Grunwaldzka **Posted Date**: Sep 10 2024 The European Partnership Markets (PM) is one of the largest regional businesses in the two European regions, and operates as an innovative partnership business model across 16 markets within Central, Eastern and Southern Europe and the Baltics,...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Belimumab**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market...

  • Medical Scientific Liaison Hematology

    il y a 2 semaines

    Wavre, Belgique AbbVie Temps plein

    **Company Description** **Job Description** Job purpose & objectives**: The **field**-based role focuses on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and providers). The focus of this role is on **interacting** with, and supporting the needs of, **Tiered External Experts in...

  • Medical Science Liaison Hematology

    Il y a 8 mois

    Wavre, Belgique AbbVie Temps plein

    **Company Description** **Job Description** Job purpose & objectives** The **field**-based role focuses on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and providers). The focus of this role is on **interacting** with, and supporting the needs of, **Tiered External Experts in...

  • Medical Science Liaison Benelux

    Il y a 6 mois

    Wavre, Belgique Abbott Laboratories Temps plein

    Abbott is recruiting a Medical Science Liaison (MSL) Benelux for our Diabetes Care division (ADC). The MSL provides scientific expert advice and guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders / external experts and provides scientific affairs support...

  • Head of Regulatory Affairs

    il y a 3 semaines

    Wavre, Belgique PaHRtners Temps plein

    - Type of role Regulatory & Medical Affairs Share Our client is a biotechnology company based in Liège. This human-sized structure provides innovative solutions to medical needs concerning infections, with the ambition of progressing towards the next clinical steps. To support growth and join the team, we are actively looking for a: Head of Regulatory...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - RSV**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Herpes zoster**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Pneumococcal MAPS**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...

  • Medical Data Reviewer

    Il y a 6 mois

    Wavre, Belgique Amaris Consulting Temps plein

    **Job description**: We are currently seeking a dedicated and experienced Medical Data Reviewer to join our team at Amaris Consulting. This role is designed for professionals with 2 to 7 years of experience, offering an Undetermined Duration Contract in Belgium. As a Medical Data Reviewer, you will play a pivotal role in ensuring the scientific consistency...

  • Senior Director, Global Real-world Evidence

    Il y a 3 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 End date job posting: 7th October 2024 **_ Chief Patient Organisation_** - The Chief Patient Organisation led by the Chief Patient Officer is accountable for bringing external perspectives of thought leaders, academic...

  • Sr. Regulatory Affairs Specialist

    Il y a 6 mois

    Wavre, Belgique Abbott Laboratories Temps plein

    For our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux. The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule. Role and Responsibilities: - Formulate, develop and manage a program...

  • Medical Data Reviewer

    Il y a 6 mois

    Wavre, Belgique amaris Temps plein

    Job description **Job Description**: We are currently seeking a dedicated and experienced Medical Data Reviewer to join our team at Amaris Consulting. This role is designed for professionals with 2 to 7 years of experience, offering an Undetermined Duration Contract in Belgium. As a Medical Data Reviewer, you will play a pivotal role in ensuring the...

  • Global Category Manager, R&d Medical Affrairs

    Il y a 4 mois

    Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre **Posted Date**: Aug 30 2024 In this role, you will be responsible for category management in the Medical Affairs R&D Procurement Team. This will include the development and implementation and on-going management of category strategies, contracting for master/service agreements, management of supplier relationships and...