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Head of US Clinical Operations

Collegeville, PA
Closing date
May 26, 2022

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Health Sciences, Medicine
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Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 11 2022 Head of Clinical Operations US - Accountable for the execution and delivery of both Rx and Vx sponsored human subject research across all therapy areas and development phases in a key strategic market for GSK. This is a leadership role reporting to the Head of Global Monitoring and Site Engagement that must matrix extensively with internal and external stakeholders. The individual must have the skills and competencies to manage difficult prioritization discussions and negotiate across stakeholders. An in-depth understanding of the local health care environment, superior leadership capabilities and proactivity are required. The individual in the role requires a high level of knowledge, experience and talent to well-represent GSK R&D within the local environment and to represent the country at the global level. This role will provide you the opportunity to lead key activities to progress your career. Job purpose and key responsibilities: • Accountable for strong leadership, people management, talent retention and development within the Clinical Operations Team in country, providing direction and vision. Translates the organisation vision, mission and strategy into coherent plans / requirements that can be understood and implemented by clinical research staff. This includes ensuring that all teams understand and operate according to the agreed business priorities, regulatory requirements and internal processes in order to ensure excellence in the delivery of studies and projects. • Accountable for execution and delivery of Pharma and Vaccine sponsored human subject research across all therapy areas and development phases in their country to quality, time, budget and resources as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and GSK written standards. He/she also has responsibility to provide clinical monitoring oversight towards studies executed by our strategic partners in the country. Where relevant, this role is accountable for study delivery and clinical monitoring oversight in non-footprint countries. • Expert knowledge of the opportunities and challenges of delivering studies within LOC and ability to maintain strong collaboration and engagement with various external stakeholders as well as internal stakeholders in Research and Development (R&D) including Therapy Area Heads, Clinical and Medical Leaders, Asset Leaders, Regional Clinical Operations Directors and other Clinical Operations Managers in order to effectively deliver the portfolio and execute the R&D strategy. • Works with the functional heads to resolve key operational issues at local, regional and global level. Actively engages with local industry partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in the country. • He/she drives, business efficiencies, implementation of new processes and quality improvement, facilitates sharing of best practices, learnings and expertise at a local, regional or global level where appropriate. This role contributes to the LOC's immediate and long-term successes. He/she is member of the regional and global in-country clinical operations network and has above country accountabilities to ensure R&D objectives are met. • Ensures the quality and integrity of clinical studies conducted in the LOC by implementing quality and risk management plans. Actively identifies and manages any internal and external risks to the business. Has oversight of LOC Business Continuity Plans (BCPs). • Full operational and financial accountability for the clinical operations country budget. • Promotes the profile and credibility of the department with internal groups with global clinical operations and beyond as well as external groups (hospitals, GP networks, physicians, HCPs, industry initiative groups etc) in order as well to develops operational strategies (12-18m months horizon) of an adequate network of clinical sites and other external partners (ethics committees, study support vendors, etc) to support local and global development needs in support of large portfolios. • Ensures strategic local input is provided at early stages of clinical development planning to optimize study feasibility in-country, interacts with country medical director/Local Medical Leads and global project teams to contribute to the development of operationally robust clinical plans. • Develops and implements a resourcing strategy (internal staff and/or external resources) to ensure availability and competency of resources needed to meet portfolio requirements and accountable for forecasting and management of country budget (IPE and EPE) • Leads cross-country/cross regional projects and initiatives • Ensures that key country feedback from LOCs and investigators is captured and shared with relevant internal stakeholders within clinical operations and R&D to inform the design and execution of the clinical portfolio. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • University Scientific degree coupled with line and project management experience. Any general science degree e.g. life science, medicine , clinical research degree, pharmacy. • 8+ years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development, in a multidisciplinary environment. • Demonstrated leadership experience (>5 years) in managing the delivery of a large and complex portfolio of time-critical activities preferably in a regulated environment. • Excellent knowledge of ICH GCP and in depth knowledge of drug and vaccine development process. • Excellent leadership skills with demonstrated ability to build and maintain highly efficient and performing teams in complex environments • Excellent verbal and written communication, negotiation, presentations and relationship skills to drive business performance. • Business acumen and demonstrated ability to think strategically, quickly appreciate the differing perspectives in a given situation and achieve a win-win outcome Preferred Qualifications: Masters of Science, PhD or equivalent coupled with line and project management experience *LI-GSK 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, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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