Global Clinical Development Operations (GCDO) Early Development Trial Leader, Associate Director - Belgium, United Kingdom, Netherlands, United States
Our company is recruiting for a Global Clinical Development Operations (GCDO) Early Development Trial Leader (ED GTL)
We focus on treating, curing and preventing some of the most devastating and complex diseases of our time.
We pursue the most promising science, wherever it might be found.
- The Early Development GCDO Trial Leader (ED GTL) has primary global accountability at the trial level within the GCDO organization. The ED GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned early development clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.
- is accountable for oversight of external service providers (ESP), including ESP contracts and budgets. In addition, he/she will be involved in planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report and applicable disclosure of the trial results.
- The ED GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and collaborates with all trial team members, building the trial operational plan, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team’s objectives. The ED GTL defines risk mitigation strategies and ensures implementation thereof.
- The ED GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization; this includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
- ED GTL at Associate Director level, may also represent GCDO at a Clinical Team, on behalf of the ED Global Program leader (GPL) and take on ED GPL responsibilities for operational input in the clinical development plan, accountability for GCDO deliverables with regards to time, quality and budget, including GCDO resources, for all ED and Clinical Pharmacology trials of a program.
- Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of Corrective and Preventive Action Plans
- You are responsible for overall trial budget and contract management, including updates for scope changes, review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered.
- You are responsible to drive the final study placement, and ensure alignment with and communication to the involved partners, including TA and regional GCO TA experts
- Develop the trial ESP strategy for the assigned trial in line with the overall program ESP strategy.
- You are responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO.
- Builds and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
- Participates in preparation for, Health Authority inspections and internal QA audits.
- Accountable to drive lessons learned initiatives at trial level during and after trial achievement completion; accountable for developing subsequent issue resolution and process improvements as required.
- Strong interaction with the Therapeutic Area, other GCDO functions, Biomarker groups, Clinical Pharmacology, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
- You do not have any direct reports . The ED GTL may be involved in coaching/mentoring of other ED GTLs and Trial Team or Study Management Team members.
- You possess a Bachelor’s or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)
- You have 8 or more year’s clinical trial work experience in the pharmaceutical/ medical device industry and/or CRO.
- Strong knowledge in Early Development clinical trials is highly preferred. An exploratory scientific mindset with focus on disease area and PK/PD/biomarkers is recommended
- You are able to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management.
- You excel in organizing and motivating global or regional teams in a virtual environment.
- You are a coach and a mentor.
- Able to travel up to 20% of the time, (as defined by business need).
- Relevant experience in the Early Development of one of more of our company's Therapeutic Area s and/or healthy volunteer studies.
- As an employee we consider you as our most valuable asset. We take your career seriously.
- As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.