Latest Job Opportunities at GlaxoSmithKline (GSK)

Job Purpose

Hiring

• The changes proposed under Future Ready are to integrate the Rx and Vx organisations and are driven by a belief that working together to drive a common approach to all GSK R&D will ultimately help us create better, more productive R&D for patients, by being more effective in how we allocate our budget, share technical expertise and deliver our pipeline. It includes the creation of a world class OneDevelopment organisation which will deliver one, consistent world-leading development support for GSK’s pipeline. Global Clinical Operations is integral to the success of the OneDevelopment organisation.
• Global Clinical Operations is transforming to fulfil our vision to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.
• To work with the Director Regional Risk Management & Management Monitoring to ensure that Clinical Research activities are conducted by Regional Clinical Operations Staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.
• To work across Regional Teams to share best practices and collaborate with other Managers on ways of working.

Key Responsibilities

• Assesses potential regulatory compliance issues and risks in clinical research activities conducted by Regional Clinical Operations Staff and to ensure these risks are properly managed, documented and escalated as appropriate within GSK.
• Ensures that Regional Clinical Operations Staff are appropriately trained to effectively conduct clinical research activities and receive ongoing training to meet the changing regulatory environment and updates to GSK written standards.
• Active contributor to the Global Quality and Training Network, taking on a leadership role for specific training and quality activities as part of the network. Also a member of any local quality teams.
• Maintains an external focus, vigilance and networks to identify emerging trends in quality and compliance which impact the GICCO business area.
• May Mentor and train colleagues throughout the Regions and act as the SME for the teams.
• Responsible for all Clinical Operational quality issues locally and ensuring Clinical Research activities are conducted according to ICH GCP, local legislation and GSK written standards.
• Responsible for the development and maintenance of local Risk Register, Quality Plan and delivering all aspects of business management monitoring activities in partnership with the business.
• Responsible to implement ongoing quality improvement processes, maintain local written standards and support all assessments and inspections.
• Accountable to design (when required), develop (when required) and deliver training identified globally and at a local level to support clinical operations processes and GSK written standards.
• Identify and address any additional local training needs.
• Mentor team staff across the regional teams.

Other Skills

• Excellent understanding of clinical research and the drug development process.
• Can work both independently on projects and also part of a team.
• Creative, logical, strategic thinker
• Effective problem solver and conflict resolution
• Good eye for detail and high learning agility
• Excellent knowledge of ICH GCP / IND guidelines
• Excellent knowledge of global and local GSK written standards.
• Sound understanding of the Internal Control Framework
• Able and willing to travel as required for the role.
• Act as a role model in line with GSK values and behaviors
• Collaborative and open Leadership style

Knowledge/Education Required

• Minimum Level of Education Required
• Scientific Degree or equivalent experience ideally with some quality experience

Area of Specialization

• Any science degree e.g. life sciences, medicine, clinical research, pharmacy etc.

Basic Qualifications/Experience

• 5 years experience in Clinical Operations. Advanced knowledge of the drug development processes and key operational interfaces
• High degree of organizational awareness; good understanding of clinical/corporate governance principles and demonstrated ability to develop solutions to complex problems with regard to quality and governance.
• Ideally have previous experience in quality management, knowledge of GSK written standards and experience in delivering clinical research training.
• Extensive knowledge of ICH GCP requirements with strong knowledge of local and global regulatory requirements applying to Clinical Trials.
• Proven negotiation skills
• Good written and verbal communication skills in English.
• Fluent in local language if required.
• Advanced user of MS Office (PowerPoint, Excel, Word & Outlook)

Preferred Level Of Education

• Master of Science or equivalent. Advanced degree preferred but not essential

Area of Specialization

• Any science degree e.g. life sciences, medicine, clinical research, pharmacy etc.

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Job Purpose

• Medical Advisor (Respiratory and other): Customer Facing. Has significant pharmaceutical industry experience and respiratory expertise, network and capability. Adds value internally by contributing to GSK medical / commercial strategy development and execution, and externally through scientific engagement with HCPs, academics, opinion leaders and other stakeholders. Works in strong collaboration with other GSK functions and supports promotional and disease awareness activities when appropriate.

Scope

Countries of responsibility: South Africa

Essential Job Responsibilities

INTERNAL (30% of time)

• Aligns closely and works collaboratively with Medical/Marketing teams to develop and execute Medical Plans.
• Develops deep understanding of the local patient-population demography, dynamics and healthcare needs and uses this knowledge to inform strategy development.
• Adds therapeutic area expertise to the medical team, and transfers knowledge within the organisation and externally.
• Supports execution of the commercial and medical strategies.
• Supports external scientific engagement, advocacy and medical education activities.
• Provides medical training to GSK teams working in the respiratory area.
• Supports the Commercial Excellence team in ensuring the sales force has a depth of understanding that allows them to execute their role successfully.
• Works closely with country medical advisors to ensure robust country medical plan development and supports in-country execution.
• Supports the implementation of Pharmacovigilance and Medical Affairs activities.
• Champions strong Medical Governance and Pharmacovigilance.
• Develops a strong network internally to leverage GSK’s considerable global resources.

EXTERNAL (70% of time)

• Identifies and fosters professional relationships with HCPs/External Experts (EEs), professional associations and other key stakeholders.
• Develops and executes a plan to proactively engage HCPs and EEs to enhance patient outcomes, share GSK’s science and support business performance and priorities.
• Leverages therapeutic area expertise to ensure GSK produces best in class, customer-centric medical and commercial engagements.
• Scientific / Expert speaker at GSK sponsored programs (including pro-active on-label group presentations), symposia, webinars and other internal or external meetings.
• Provides support and resources for external meetings, including attendance at relevant congresses.
• Is a presenter to Therapeutic / Guidelines / Formulary / Funder committees.
• Responds to unsolicited inquiries for medical information.
• Supports GSK sponsored Advisory Boards.
• Supports clinical operations / investigator engagement.
• Will be expected to travel.

OUTPUTS

• Development and execution of brand specific Medical Operational Plans
• Delivery of medical and scientific materials and programs
• External medical stakeholder mapping and relationship management
• Ensures that all activities undertaken, whether product-related or disease-related, post-authorisation or pre-authorisation, internal or external, at whatever point in the lifecycle of a GSK product, are within the bounds of GSK, local and international ethical standards, whichever is stricter.

Required

• Qualifications, Experience, Competencies:
• MBChB
• Fluent in English and high level of computer / digital literacy
• Excellent communication and presentation skills
• Strategic and scientific thinker
• Strong ability to apply and communicate scientific and medical knowledge
• Ability to manage complexity and work in matrix teams

Desirable

• Strong respiratory scientific expertise and clinical experience
• Established network within local (respiratory) KOL and academic communities
• Business and financial acumen
• Strong leadership potential
• Pharmaceutical industry experience