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Oncology Study Delivery Lead, Cell and Gene Therapy

Collegeville, Pennsylvania
Closing date
Dec 15, 2021

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Life Sciences, Cell Biology, Oncology
Organization Type
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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford Posted Date: Dec 8 2021 GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for Clinical Operations Leaders who have experience leading global studies. It's a wonderful time to join our team because have multiple open positions in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality. Apply to learn more! Remote working outside of listed locations may be considered for the qualified applicant by exception and given willingness to agree to ways of working which meet both the needs of the individual and the business. This position within Global Clinical and Study Delivery (GCSD) and is accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. Accountable for the study delivery strategy (e.g. country selection, diversity, patient engagement strategy, recruitment plan, etc) Drive assessment, selection, engagement, and management of appropriate vendors. Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate. Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation. Actively partner to build relationships and collaborate with oncology aligned staff in other global functions. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in life sciences or related discipline. Six or more years of clinical development experience in the pharmaceutical industry or CRO environment One or more years experience in Global clinical operations leadership experience Two or more years experience in study management, global regulatory guidelines and ICH/GCP Two or more years experience working with investigators, external experts, Contract Research Organizations and vendors Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience leading the delivery of oncology clinical trials is preferred. Clinical development experience across all phases of development (I-IV). Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Excellent influencing and negotiation skills Excellent project management and leadership skill Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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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