Clinical Pharmacology Modelling & Simulation
4 days ago
Stevenage
Overview GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together. Role Overview The Biomarker Operations Team within Platform Sciences provides operational support for clinical pharmacology (including PK), biomarker project plans, translational research studies, and diagnostic (Dx) development. Roles in this group collaborate with various internal departments and external partners to progress Clinical Pharmacology Modelling & Simulation (CPMS), Biomarker and Diagnostic (Dx) activities across the Respiratory, Immunology, and Infectious Disease (RIID) and Oncology portfolios. Specifically, this role is for a CPMS Contract manager who will ensure internal stakeholder alignments, track project deliverables, identify and mitigate risks, and communicate with relevant stakeholders. Additionally, they will reconcile activities with contracting and finance operations and provide advice to the CPMS department and client groups. This will support decision-making with respect to outsourcing by developing detailed specifications, analyse proposals (for both service (activity) and cost provision), negotiate (both costs and content) and execute new and amended contracts that are robust, timely, and add significant opportunity for value generation to the business whilst minimising risk. Key Responsibilities • Vendor and Contract Management: Managing vendor contracts, approving invoices, and ensuring compliance with GSK policies and procedures. This also involves developing and negotiating clinical service provider contracts., • Demonstrate broad knowledge of biomarker and pharmacokinetic outsourcing with awareness of Dx technologies, and IVD development., • Financial Oversight: Tracking and updating project budgets, milestones, and payments., • Risk Management: Identifying and communicating risks related to timeline, budget, and scope to stakeholders in a timely and clear manner., • Collaboration and Communication: Working closely with internal teams and external partners to ensure project objectives are met. Regular communication of timelines, milestones, and goals to stakeholders is essential., • Stakeholder Management: Develop key stakeholder relationships liaise between GSK and external suppliers to provide value-added customer service., • Compliance and Documentation: Ensuring compliance with GSK policies and procedures, maintaining accurate records, and supporting regulatory submissions., • Demonstrate the ability to take on new challenges and drive them to successful completion. Minimum Qualifications • Bachelor’s degree in biological sciences or related discipline; advanced scientific degree a plus, • Minimum of 3-5 years of project or program management experience in the Dx, pharmaceutical, or biotech industry, clinical development, • Experience managing bioanalytical, clinical biomarker, and/or In Vitro Dx development programs, • Experience managing third party vendors, vendor contracts and budgets including approval of invoices, • Understanding of drug discovery and development, clinical trial design, and overall principles of clinical development, • Established expertise and hands-on experience with Word, Excel, PowerPoint, Outlook, SharePoint, remote meeting tools such as MS Teams, WebEx, etc. and a working understanding of innovative AI technologies (e.g., CoPilot, ChatGPT, GiGi, Jules, etc.) Preferred Qualifications • Strategic thinking and ability to work effectively in a matrixed environment while managing multiple projects/competing initiatives simultaneously., • Excellent time management, organizational skills, and results focused., • Ability to establish trust, work with integrity, and motivate others to achieve project goals., • Highly effective communication and negotiation skills for various audiences, including technical and business stakeholders., • Financial analysis experience with a proven track record in budget management, contract financial analysis, and negotiation., • Strong negotiation, influencing, analytical, problem-solving, and facilitation skills within the pharmaceutical or CRO industry., • Knowledge of clinical pharmacology and the use of PK data to inform drug development programs., • Knowledge of electronic trial master file and filing of clinical trial documentation, • Experience in pharmaceutical development and companion Dx, including analytical and clinical validations and regulatory submissions., • Good understanding of CPMS analysis including non-compartmental analysis techniques would be an advantage. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Inclusion at GSK GSK is an Equal Opportunity/Affirmative Action Employer. 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. If you need any adjustments in the recruitment process, please get in touch with our Recruitment team () to further discuss this today. 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. 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