Oncology Global Clinical Development Associate

Il y a 2 mois

Wavre, Belgique GSK Temps plein

**Site Name**: Canada - Ontario - Mississauga, Belgium-Wavre, GSK House, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw

**Posted Date**: May 5 2023

**Global Clinical Development Associate Director**

**The Role**

Reporting to the Study Delivery Lead (Team) Director, 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. This position within GCD is accountable for planning and leading the delivery of paediatric oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.

The role may span oncology assets from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. This role is highly visible within Global Clinical Operations and in the Clinical Matrix Teams.

Key attributes include demonstrated ability to input to and influence studies/projects through operational expertise and demonstrated excellence in stakeholder management. This job requires competent strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.

**Key Responsibilities**
- Accountable for the global study delivery strategy (e.g., country selection, diversity, patient/carer engagement strategy, recruitment plan, etc) and for overall study deliverables
- Drive assessment, selection, engagement, management, and oversight of appropriate vendors
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation
- Preparation of materials for governance and / or financial review cycles
- Actively partner to build relationships and collaborate with oncology aligned staff in other global functions
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
- Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary
- Identify and communicate resource gaps for assigned studies
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
- Lead / contribute to ways of working and process improvement initiatives
- Provide expert clinical operational input into protocol development
- Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study
- Actively partner to build relationships and collaborate with Oncology aligned staff in other global functions e.g., partnering with functional lines to deliver the Clinical Study Report
- Work with the Oncology paediatric patient councils, paediatric networks, and advisory groups to develop paediatric patient centric documents and address paediatric patient burden

**_ Closing Date for Applications: 28th May 2023 (COB)_**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

**Why you?**

**Basic Qualifications**

We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree in life sciences or related discipline
- Extensive clinical development experience with at least 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment
- Experience managing paediatric oncology studies globally, through start up, maintenance and close out
- Experience in developing robust paediatric recruitment plans in a challenging patient population
- Proven operational experience of leading high performing global study teams in clinical trials
- Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget
- Excellent leadership skills, influencing and negotiation skills
- Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change
- Working knowledge of the paediatric regulatory environment
- In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP
- Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with C

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