puestos de Clinical Research en Emiratos Árabes Unidos

GSK Oncology Early Clinical Development is seeking a highly skilled and motivated Early Clinical Development Medical Director- Oncology, to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and Pre-clinical/ Discovery teams to improve forward and reverse translation and, thereby, increase the success of our Oncology clinical portfolio in the prostate cancer space. This role offers a unique opportunity to bridge the gap between preclinical research and clinical development, ensuring the successful translation of innovative therapies from the lab to the clinic.

The Early Clinical Development Medical Director- Oncology will report to the Executive Medical Director, Early Clinical Development Lead (ECDL)-GU, Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials, in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents for patients with prostate cancer.

Please note: This position requires an on-site office-based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
• Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted prostate cancer patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee review of data packages intended for internal and/or external IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of data during dose escalation and expansion studies and subsequent publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

We are looking for professionals with these required skills to achieve our goals:

• Medical degree from accredited medical school
• Completion of a clinical residency program
• Experience in clinical research and development in Oncology
• Experience working in the pharmaceutical/biotechnology industry in prostate cancer.

If you have the following characteristics, it would be a plus:

• Oncology experience in pharmaceutical/biotechnology industry preferred
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

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.

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $176,250 to $293,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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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, visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.