Global Clinical Development Director, Open to flexible working
- Contract Type
GSK is expanding its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting portfolio and are looking for Clinical Operations Leads who have a wide breadth of oncology and clinical development experience. It's a wonderful time to join our team because we have many opportunities to lead global studies and programs in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality. Apply to learn more!
This position within Global Clinical and Study Delivery (GCSD) is accountable for end to end delivery of global oncology studies and may include leadership at the project team setting and across matrix teams
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Be responsible for the delivery and quality of clinical oncology studies from protocol concept to final study report. This includes the writing of protocols, Informed Consent Forms, study procedure manuals, clinical study reports and regulatory-related documents. It also includes management/oversight of CROs and vendors.
- Work with matrix partners to develop and manage study level budget within project budget allocation.
- Create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development.
- Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to operational achievements.
The role may:
- Have accountability for the management, performance and motivation of direct reports.
- Have primary responsibility for delivery of a program of studies (or indication-specific group of studies) and be key point of contact for portfolio leaders in the Oncology Therapeutic Area (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate).
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences or related discipline
- At least 10 years of clinical development experience in the pharmaceutical industry or CRO environment
- At least 5 years of oncology clinical operations experience
- Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports
- In depth knowledge of study management, global regulatory guidelines and ICH/GCP
- Experience working with investigators, external experts, Contract Research Organizations and vendors
If you have the following characteristics, it would be a plus:
- Advanced degree (e.g. MS, PhD, PharmD)
- 10+ years of oncology clinical operations experience
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Excellent leadership skills
- Excellent influencing and negotiation skills
- Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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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