Clinical Country Operations - External Partnerships Lead

Clinical Country Operations - External Partnerships Lead
+ Requisition ID:WD81113
+ Position:Full time
+ Open date:Aug 3, 2016 6:16 PM
+ Functional area:Medical and Clinical
+ Location:Maryland
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+ + Required degrees:Bachelors
+ Experience required:10 years
+ Relocation:Not Indicated
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Basic qualifications:?Bachelors degree
? 10+ years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development and project management, ideally in a multidisciplinary environment OR 5+ years in consulting with development programs or product strategy mainly in pharma / biotech industry with at least 2 years in an engagement manager role or equivalent
Preferred qualifications:? Well-organized, excellent time management with respect to priorities and self-management
? Able to work in ambiguous circumstances and take actions quickly while involving the right team members in the right situation at the right time
Masters or PhD preferred
? Demonstrated interpersonal skills and team player with demonstrated ability to build collaborative relationships at all levels inside and outside of the organization, specifically with line management staff and with management at all levels in partner vendor organizations
? Proven negotiation skills
? Demonstrated experience managing multiple strategic partnerships
? Solid knowledge of drug development process; preferably of vaccines / biologics development
? Demonstrated analytical skills and ability to think / frame problems strategically
Details:We are seeking a Clinical Country Operations-External Partnerships Lead for our new U.S. R&D Center in Rockville, Maryland. You will have the opportunity to be on the ground floor of a new organization and site, and you will be part of a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D projects through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.
The position has accountability for appropriate availability and utilization of external partner support of all Phase I-IV US vaccine clinical trials to assure delivery of assigned studies to time, budget and quality expectations. This includes high level management of US clinical site deployment across the US Vaccines portfolio of clinical studies and ensuring that other third parties providing a variety of deliverables in support of clinical studies are coordinated across the US Clinical Operations team in alignment with global Vaccines vendor strategies and practices.
EXTERNAL VENDOR MANAGEMENT
? Serve as primary US Vaccines Clinical Operations point-of-contact with business partners and leaders within and beyond US organization to manage flexible resourcing deployment, agree optimal study execution approach and quantify external resource requirements across time and as portfolio needs evolve
? Consolidate results of internal oversight assessments of vendor performance and share feedback with internal vendor alliance management groups as appropriate
? To the extent necessary, ensure all locally-specific requirements are communicated to vendor(s) and that vendor plan to assure vendor staff competency is adequate
CLINICAL INVESTIGATOR RESOURCE POOL MANAGEMENT
? Responsible for clinical investigator deployment across the portfolio to ensure clinical site availability is not rate-limiting to clinical development plans within country
o Leads the management of historical performance information of GSK investigators and identification of potential investigators without GSK Vaccine history to ensure that potential US investigator pool is understood and can be strategically managed across portfolio
o Build and develop new investigators to address new therapeutic areas and increase number of potential investigators in high-demand areas
o Provide projected subject recruitment timings and other input in support of development planning and country feasibility assessments at both study and portfolio level
o Ensure delivery of list of sites to be considered for each study based on strategic site allocation considerations across the portfolio
CLINICAL SITE COLD STORAGE UNIT, ANCILLARY SUPPLIES, AND SAMPLE MANAGEMENT
? Accountable party within GSK for oversight/ownership of external (non-GSK) vendor managing clinical site cold storage unit (refrigerators & freezers) validation process (includes initial assessments and periodic re-validation)
? Manage and or foster new vendor relationships and improve the process to deliver clinical ancillary supplies and the coordination of sample management within the region.
U.S. Prosecution
?Works with patent attorneys to prepare and file patent applications, responses to Office Actions, and other communications with the U.S. Patent & Trademark Office.
?Prepares Information Disclosure Statements, and reviews references cited in related office actions for same.
?Reviews patent application prior to payment of Issue Fee, ensuring all amendments have been entered and references cited in IDSs have been acknowledged.
?Proofreads issued patents and prepares Requests for Certificate of Correction.
?Prepares Assignments, Declarations, Powers of Attorney and related documentation associated with U.S. patent applications.
International Prosecution
?Responds and corresponds with foreign associates to facilitate ongoing prosecution of foreign patent applications.
?Prepares lists of references to be cited in foreign countries and communicate same to foreign associates.
?Obtains instructions from attorney and coordinates filing of Requests for Examination.
?Obtains instructions from attorney and coordinates payment of grant fees.
Dockets
?Monitors docket reports on a daily basis.
?Communicates updates/changes to attorneys.
?Works closely with attorneys, clients and foreign associates to remind them of deadlines, obtain instructions and meet filing deadlines.
LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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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