(Sr.) Clinical Development Director - Rheumatology/Immunology

Collegeville, Pennsylvania; San Francisco, California; Waltham, Massachusetts; Warsaw, Poland
July 13 2021
Organization Type
Site Name: Belgium-Wavre, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, Warsaw, USA - Pennsylvania - Upper Providence Posted Date: Jul 13 2021 Are you energized by the opportunity to lead global drug development programs, driving accelerated business performance to bring new treatments to patients? If so, consider exploring this opportunity. A Senior Clinical Development Director is sought to provide clinical and scientific support for potential and established indications for belimumab and emerging indications for other early and late stage assets in the immunology portfolio. As Senior Clinical Development Director, you will work with project teams to plan and assure delivery of clinical research and development activities. You will work with early development teams to plan clinical development programs and establish efficient collaboration between Research and Development. Job purpose and key responsibilities: 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 areas. Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP). Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, taking into account the scientific rationale, regulatory requirements, product development plan and commercial goals. Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contribute to the strategic and organizational initiatives in Clinical Development. Contribute to Business Development activities, including due diligence projects. Support technical and leadership development of Clinical Sciences staff via direct line management, 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 to business strategy and address patient needs Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs. Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients. Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate. Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions. Champion implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions Why you? Basic Qualifications: Bachelor's degree in a science field Extensive clinical drug development experience Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects. Experience working collaboratively with multiple stakeholders on complex projects. 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 Line management, coaching, mentoring and development experience Strong leadership skills, with proven ability to inspire high performance from cross-functional teams Track record of building and maintaining strong relationships with internal and external stakeholders Preferred Qualifications: MD, PhD or PharmD degree v Thorough understanding of immunologic diseases, underlying biology and potential therapeutic targets Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s) Experience leading line and matrix teams with a track record of inspiring and motivating high performance 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: 31 July 2021 *LI-GSK GSK_CDLeaders 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. 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