GSK

H1B vīzas sponsors Farmaceitiskie produkti Ražošana Veselības aprūpe

GSK ir globāls veselības aprūpes un farmācijas uzņēmums, kas apvieno zinātniskos pētījumus, tehnoloģijas un specializētu talantu, lai izstrādātu zāles un vakcīnas. Uzņēmuma darbība aptver slimību profilaksei un ārstēšanai paredzētu produktu atklāšanu, ražošanu un piegādi, piedāvājot iespējas sniegt ieguldījumu veselības aprūpes inovācijās lielā starptautiskā organizācijā.

Vakances uzņēmumā

Director of Clinical Operations, Asset Lead

Lead GSK’s clinical operations strategy and delivery for vaccines and medicines across an asset’s lifecycle. Oversee planning, governance, vendors, risks, and inspection readiness.

pirms 2 stundām

Apvienotā Karaliste

81 750 € – 136 250 € / gads

Hibrīdi Pilna slodze Vecākais speciālists Nepieciešamā Valoda: angļu Klīniskās operācijas

Google Cloud Platform

Apraksts

Account for clinical operations delivery throughout the asset lifecycle.
Develop and execute program-level operational strategy in support of the scientific vision.
Work with clinical, biostatistics, and functional experts to guide decisions.
Lead Study Delivery Teams and ensure timely, high-quality delivery.
Contribute to Clinical Development Plans and Integrated Evidence Plans across Research, Development, and lifecycle management.
Ensure study designs are feasible to deliver, regionally compliant, cost-effective, and capable of producing high-quality data.
Provide operational input at protocol level and support amendments through governance review.
Set resourcing strategy for the asset across internal and outsourced models.
Approve vendor selection, contracting, and oversight in accordance with GSK standards.
Escalate critical operational, quality, and GCP issues.
Coordinate cross-functional work to prepare for inspections and deliver high-quality studies.
Manage asset delivery plans, scenario models, budget forecasts, risk registers, and mitigation plans.
Represent Clinical Operations at governance boards and support clinical filings.
Manage engagement with internal and external stakeholders across the asset.
Maintain accurate, up-to-date operational records in GSK systems until responsibility transfers to study teams.

Prasības

Bachelor’s degree in a general, life, or health science.
Extensive strategic experience leading and delivering complex clinical research portfolios or equivalent initiatives with significant business impact.
Expertise in end-to-end clinical development and the regulatory landscape.
Experience providing strategic guidance and independently leading complex cross-functional teams.
Experience navigating and planning for multiple regulatory pathways that may be pursued simultaneously across indications.
Ability to develop and execute integrated strategic plans across multiple workstreams and indications for a large asset or interdependent assets.
Strong leadership skills and experience building and managing matrix teams in complex, high-pressure settings.
Strong influencing and stakeholder management skills at all organizational levels, including SVP and C-level.
Ability to work through complexity and uncertainty in the external regulatory environment, including FDA and EMEA.
A master’s degree in a general, life, or health science, or an MBA, is preferred.
Experience leading or contributing to operational integration for business development deals is preferred.

Priekšrocības

Annual bonus.
Eligibility for a share-based long-term incentive program.
Health care and other insurance coverage for the employee and family.
Retirement benefits.
Paid holidays.
Vacation.
Paid caregiver, parental, and medical leave.
Agile working culture and flexible working opportunities.

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Director of Clinical Operations, Asset Lead

Lead GSK’s clinical operations strategy and delivery for vaccines and medicines across an asset’s lifecycle. Oversee planning, governance, vendors, risks, and inspection readiness.

Apraksts

Prasības

Priekšrocības

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