GSK

Senior Clinical Research and Development Lead (Sr. CRDL)

Employer
GSK
Location
Rockville, MD
Salary
Competitive
Posted
November 06 2020
Ref
266537
Organization Type
Pharma
To conduct Phase I-IV Clinical Development activities within a large program or group of related programs (led by a Clinical and Epidemiology Research & Development Project Lead - CEPL) or, for a mid-size program, to lead Clinical Development activities within the context of the GSK Vaccines process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Vaccines standard operating procedures (SOP).

Participate at a senior level in Clinical Development activities for a series of studies within a large program or group of related programs or, for a mid-size program, lead Clinical Development activities.
  • Where applicable, lead matrix team, to author clinical development plans, design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability will be to Clinical and Epidemiology Research & Development Project Lead (CEPL).
  • Responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CEPL.
  • Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator's Brochure and the Clinical Study Report.
  • Where applicable, support or act as the delegate of the Clinical and Epidemiology Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed
  • If applicable, represent clinical development within Vaccine Development Team (VDT), Vaccine Commercial team (VCT), Discovery Performance Unit (DPU,) Protocol Review Board (PRB), Toxicology Working Group (TWG), etc.
  • If appropriate, support the CEPL or serve as delegate of the CEPL as the principal liaison to Independent Data Monitoring Committee (IDMC).


Serves as a scientific and management reference for the project (internally/externally)
  • Supports internal process improvement activities and initiatives involving coordination of multidisciplinary working team across departments (clinical, safety, regulatory) and maintains contacts with internal and external stakeholders (e.g., Brighton collaboration working group, CDC, and others).
  • Assumes accountability for the medical/legal and human safety aspects of the clinical program. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
  • Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program
  • Address scientific and medical issues related to one or more projects. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
  • Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), on clinical program level accountable for. In clinical programs, together with PV analyse safety and potential signals and escalate accordingly.
  • Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
  • Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology


Budget, resourcing and timing
  • Supports the clinical team to consistently achieve high standards in attainment of project timelines in global programs.
  • Interfaces with the PDL to ensure milestone realization and resource optimization.
  • Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects' safety)


Supports or Leads the Clinical Project Team(s)
  • Support or leads one Clinical Project team (matrix teams including, but not limited to, CRDL's, Science Writers, Biostats, SDLs, and Study Data Managers) with a spirit of creativity and instills optimism and a can-do attitude.
  • Provides formal feedback, which encourages team member develop their skills. Provides performance feedback on matrix team members to responsible line managers
  • Enhances the knowledge level of the entire team by developing project-specific training programs.
  • Consistently displays creative and innovative leadership skills while working in a matrix team


Provides support to Marketing/Business Development throughout product life cycle
  • Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development as applicable
  • Provide medical support to Marketing in order to achieve Company's objectives


Actively follows-up the product-related Environment
  • Responsible for follow-up of project related literature, discussions with external experts and authors, participation in congresses and presenting GSK data.
  • Reviews and approves labeling and related promotional materials where applicable.


People management
  • Within Clinical RDC, contributes to provide leadership, direction and vision for the team of CRDL function
  • Provides input and participate in the recruitment and development of the team of CRDLs within Clinical RDC.
  • Build and foster the establishment of a CRDL community.
  • Serves as mentor in line / matrix reporting setting with an active interest in the leadership and technical development of team members.
  • If applicable, provides operational and administrative management to the Clinical RDC. In this capacity, manage direct reports (objective setting, performance assessment, career development); mentor and train junior CRDLs


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • MD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology
  • Previous experience in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is an asset.
  • Minimum 3 years industry experience or minimum 10 years experience working in a scientific or medical institution


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset
  • Good theoretical and practical knowledge in clinical research. Previous vaccinology experience highly desirable
  • Role requires the ability to translate scientific skills in the field of vaccines and clinical research into business driven strategies.
  • Understanding of GCP and ICH guidelines; experience working with Regulatory functions (i.e. filing IND, BLA, CTD) a plus
  • Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.
  • Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
  • Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP.
  • Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
  • Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
  • Strategic thinking skills and achievement oriented.
  • Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.


Why GSK?

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.


*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

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