Sr. Clinical Development Director - Lupus

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Sr. Clinical Development Director - Lupus Collegeville, Pennsylvania; Stevenage, United Kingdom; Brentford, United Kingdom; San Francisco, California; Waltham, Massachusetts Medical and Clinical 265805 Job description Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Sep 30 2020 “ GSK is a company with a rich history of innovation, with many talented scientists who care deeply about translating great science into therapies that make a meaningful difference for patients” Hal Barron Join us to today to make that difference as a Clinical leader for new Benlysta indications and potential emerging indications within our rheumatology portfolio. As the Sr. Clinical Development Director for Benlysta, you will be the Clinical Lead for several clinical trials/registries to support the post-approval commitments for Benlysta. You will work closely with the clinical and medicine development leads (CDL and MDL) for GSK’s Benlysta programs. You will report into the Vice President, Disease area lead for Rheumatology, and will be a member of the medicine development team and will be responsible for direct reports. This role will gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Supervision of ongoing clinical studies of Benlysta in lupus including registry studies to support post-approval commitments Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in a science related field Experience in Rheumatology clinical drug development Clinical training and/or applicable clinical research experience; experience with clinical development planning and running clinical trial from concept study idea to publication. Experience managing complex projects and working with multiple stakeholders regarding new strategies to ensure consistent communication. Experience integrating genetic data to advance disease understanding and and guide clinical development plans Experience with clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules Experience with digital tools intended to create innovation Experience in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content Preferred Qualifications: If you have the following characteristics, it would be a plus: MD, PhD or PharmD degree valuable but not required Thorough understanding of Primary Biliary Cholangitis, the underlying biology and potential therapeutic targets as well as current and future potential treatment options Significant years of experience leading line and matrix teams with a strong reputation 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, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation. *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 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. Sr. Clinical Development Director - Lupus Full-Time, Collegeville, Pennsylvania, United States Sr. Clinical Development Director - Lupus Full-Time, Collegeville, Pennsylvania, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Annual bonus based on company performance Flexible working options available for most roles Learning and career development Access to healthcare & wellbeing programmes

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