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Director, Early Phase CMC Medicine Research Leader

Employer
GSK
Location
Collegeville, Pennsylvania; King of Prussia, Pennsylvania
Salary
Competitive
Closing date
May 22, 2022

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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - King of Prussia Posted Date: Apr 20 2022 Are you energized by a highly-visible senior CMC leadership role that will allow you to drive and shape scientific innovation across an early phase portfolio? If so, Director, Early Phase CMC Medicine Research Leader may be an exciting opportunity to explore. The purpose of this role is to ensure the successful CMC delivery of the early phase portfolio (large and small molecule) through influencing the medicine development strategy; leading delivery of the CMC, supply chain and regulatory targets; leading the high performing matrix team; and shaping the medicine and patient experience. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. Leads the definition and implementation of the early CMC development strategy and provides options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources and time) for the early development of the medicine. Leads the cross-functional multi-disciplinary CMC matrix team to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts. Owns the performance of the CMC matrix team: partners with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project. Provides the voice of the physical product and supply chain to influence the early medicine development strategies and plans. Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent, and to the CMC functional lines to ensure they have the capability and capacity to deliver. Skills and competencies This role requires the knowledge, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable early clinical trials. An exceptional matrix leader who sets direction, empowers others to take ownership of their activities, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable for their delivery and performance on behalf of the team. Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others. A highly credible CMC expert: strong technical knowledge of process, product and analytical development with a broad knowledge of the end to end non-clinical, clinical, regulatory aspects of developing a medicine. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's of Science in Pharmacy, Biology, Chemistry, Engineering, or related CMC orientated field 8 yeras' experience in the pharmaceutical industry Experience in a technical CMC function Project leadership experience within a CMC function in a global matrixed environment Experience working in a CMC environment in Early Development Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters, PhD or MBA degree preferred with extensive CMC experience in the development or manufacture of relevant pharmaceuticals Learning agility and desire to learn; willingness to take on diverse and challenging assignments in product development Experience with relevant CMC and supply chain aspects of developing and manufacturing pharmaceuticals along with a thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements People and / or Project Leadership of large, complex, multi-disciplinary teams with high level of accountability, and preferably in a relevant pharmaceutical development environment with global teams Experience creating and defending CMC development strategy, plan and data package for an asset in early development Experience leading, developing, coaching and mentoring CMC functional leaders Demonstrated ability to develop effective business strategies to address medium to long term problems Effective communication and influence skills with senior stakeholders and governance bodies Experience working with multiple stakeholders at different organizational levels with both internal and external groups Why GSK? Why GSK? Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant 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 GSKBiopharm_development *This is a job description to aide in the job posting, but does not include all job evaluation details. 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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