Study Delivery Lead, Neuroscience, Open to flexible working
Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager role could be an exciting opportunity to explore.
As a Study Delivery Lead within Global Clinical Sciences and Delivery (GCSD), this role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Planning and leading the delivery of neuroscience studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.
- Accountable for coordination of a fully feasible Study Protocol, Informed Consent Forms, Study Procedures Manuals and Clinical Study Reports.
- Accountable for the study delivery strategy (e.g. country selection, diversity, patient engagement strategy, recruitment plan, etc)
- Drive assessment, selection, engagement, and management 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; acts to mitigate risk where appropriate.
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.
- Actively partner to build relationships and collaborate with neuroscience aligned staff in other global functions.
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences or neuroscience
- Experience in the pharmaceutical industry or CRO environment in the clinical development process.
- Global neuroscience clinical operations leadership experience, such as Alzheimer's or Parkinson's.
- Experience in study management, global regulatory guidelines and ICH/GCP
- Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
- Experience working with investigators, external experts, Contract Research Organizations and vendors
If you have the following characteristics, it would be a plus:
- Excellent leadership skills
- Advanced degree in neuroscience or related field (e.g. MS, PhD, PharmD)
- Clinical development experience across all phases of development (I-IV).
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Excellent influencing and negotiation skills
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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