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Senior Principle Supported Studies Delivery

Collegeville, Pennsylvania; Research Triangle Park, North Carolina
Closing date
Dec 4, 2021

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Health Sciences, Medicine
Organization Type
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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - North Carolina - Research Triangle Park Posted Date: Oct 19 2021 GSK Supported Studies team is being transformed into a Center of Excellence for the operational delivery of supported studies across GSK. These studies support the GSK Value Evidence (Health Outcomes) and Epidemiology Teams to develop scientifically credible, high-quality evidence aligned with the needs of regulators, the scientific community, and decision makers responsible for granting access and reimbursement. If you are energized by defining new ways of working and are looking for a leadership role where you can make a difference to patients, this could be the role for you. You are responsibility for reviewing and/or enhancing the technical and scientific robustness of protocols developed by sponsors; to lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs; to be accountable for implementing new strategies; proactively identify issues and propose strategies to manage implications and risks on study timelines, budgets and goals. The role will also support technical and leadership development of Study Delivery staff via mentoring and coaching. This role will provide YOU the opportunity to lead key activities to progress YOUR career, some of these responsibilities the following… Partner with global medical teams to agree prioritisation of studies Trusted partner with critical internal and external stakeholders (e.g., investigators) Core member of the global review panel providing expert advice on operational aspects of the supported studies proposals received Proactively managing end to end study delivery for up to 20 Supported Studies, providing operational leadership for the delivery of the assigned studies ensuring they are conducted in accordance to GSK SOPs, relevant legislation, on time and within budget. Working with the finance team to effectively forecast budget, track invoicing/payment and track actual spend Provide study performance updates to key stakeholders including budget spend per study Working with the GSK supplies teams to manage commercial and clinical supply Partner with the contract team during contracting activities when required Partner with safety to ensure appropriate safety reporting and engagement Drive innovated approaches to study delivery through external facing advances in technology and science Collaborate across TAs to identify process inefficiencies and lead solution development and implementation Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BA / BS degree Three or more years experience in late stage clinical development Three or more years experience of working in academic partnerships and/or external alliances with proven clinical project or alliance management skills Minimum of 3 years' experience in clinical operations Three or more years xxperience managing data quality, safety, risk management & regulatory guidelines Three or more years experience in pharmaceutical, healthcare or other relevant industry, such as health care consulting Preferred Qualifications: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience Experience delivering Investigator Supported Studies and/or Supported Collaborative Studies Project/alliance management Experience managing studies in systems/tools such as excel, ideapoint, Veeva vaults, PowerBI Demonstrated understanding and influence of study design Matrix leadership perience managing direct reports Proven ability to build and nurture relationships with a range of stakeholders Demonstrated ability to understand the appreciate the value of diverse perspectives and drive innovative solutions to complex problems Excellent interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management Self-motivated, with experience of working independently to establish new initiatives and encouraging high performing multi- stakeholder teams to embrace innovative approaches and new ways of working 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, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing budgets and reporting. 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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