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Clinical Development Director - Immunology

Collegeville, Pennsylvania; Waltham, Massachusetts
Closing date
Jul 22, 2021

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Life Sciences, Immunology
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Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jul 13 2021 Are you energized by the opportunity to partner with key leaders in global drug development to drive and accelerate business performance to bring new treatments to patients? If so, consider exploring this opportunity. A Clinical Development Director is sought for potential and established indications for belimumab and emerging indications from other early and late stage assets in the immunology portfolio. As Clinical Development Director, you will lead studies from the scientific perspective at multiple stages of drug development and will be a key contributor to clinical research and development activities. Job purpose and key responsibilities: Contribute to or lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease area(s). Support execution of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Ensure clinical study designs are aligned with the IEP and CDP. Provide effective support/oversight of clinical studies to assure patient safety and study delivery. Deliver to clinical trial and clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP. Develop and maintain relationships with counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contribute to the strategic and organizational initiatives in Clinical Development. Support technical and leadership development of Clinical Sciences staff via mentoring and coaching. Serve as a clinical point of contact for senior management and senior level matrix teams. Interface with and influence a range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs that align with the business strategy and address patient needs. Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients. Contribute to regulatory interactions including briefing documents, presentations, and responses to questions. Why you? Basic Qualifications: Bachelor's degree in a science field Experience in clinical drug development (at least 5 years) Clinical research experience, including planning and running clinical trials and projects, with proven record of delivery. Knowledge of ICH guidelines and regulatory and reimbursement data requirements Knowledge of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules Experience using statistical and visualization techniques to analyze and interpret complex information Team player and leader, with proven ability to build and maintain relationships within and external to a line or matrix team. Preferred Qualifications: MD, PhD or PharmD degree Understanding of immunologic diseases, underlying biology and potential therapeutic targets Experience leading line or matrix teams with a track record of high performance (at least five years) 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. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen You'll be joining a dynamic, curious and collaborative team of physicians & clinical scientists, who share your passion for great science. You will be given clear accountability, and the opportunity to inject smart risk-taking to drive the innovative development of transformational medicines for patients. We welcome your application! Closing date for applications: 31st July 2021 *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. 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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