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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This position is accountable for developing and driving the early development strategy of assets in the EODCR group in ORRD, a division of WRD, in alignment with the overall EODCR and the company portfolio strategy. The early development asset team leader (ATL) leads the asset team (AT) and is accountable for the seamless execution of all project deliverables from candidate selection and IND enabling deliverables leading to First in Subject/Patient and up to a point, at which time the asset may transition to the appropriate late phase development organization. The ATL will be responsible for approval of program and/or project plans, endorsing and integrating line function strategies. The early development ATL applies scientific knowledge, clinical and drug development experience to ensure research and development strategy of the AT can address unmet need and commercial strategies.
• Oversees clinical portfolio development from pre-FIH through to transition to late development
- Leads cross functional Asset Team(s) composed of the following standing member line functions: Clinical lead, Clinical Operations program lead, Research project lead, Development director, Translational lead, Commercial lead and Pharmaceutical Sciences team lead
• Endorses and integrates line function strategies
• Accountable for developing projects that are cost-effective and looks to de-risk the candidate and investments as early as practical (clinical portfolio level)
• Accountable for ensuring that the projects are managed appropriately per budget
• Accountable for ensuring that the necessary resources are available to the projects to support their success
• Accountable for the quality of asset deliverables to external authorities
• Promotes a culture of innovation within Asset Teams in order to bring forward creative development plans that maximize the potential of the asset.
• Candidates with MD or equivalent with post-graduate clinical training/development and experience in clinical medicine or drug development
• Minimum of 10 years of relevant post graduate experience in the pharmaceutical, academic and/or medical research environments having successfully executed a major component of a development program(s)
• Strong understanding of the elements of drug development programs and experience in their design and execution.
• Filing and defense of IND's, CTA's and full dossiers
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Approximately 10-15 % travel, mostly national
Flexible work schedule
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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