Director Global Clinical Operations Therapeutic Area Lead in King Of Prussia, PA

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compensation:

$200K - $250K

specialty:

Life Sciences

experience:

11 - 15 years

Job Description

Job Description


• Provides either strategic leadership to, and management of all clinical programs within or across Therapeutic Areas (TA) or leads a function that supports the delivery of the portfolio. Fully accountable for all deliverables to support the TAs. These functions include Clinical Operations, Business Operations and Compliance.

• Ensure all activates that support the TA model are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.

• Negotiate or support the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Drive ownership of all deliverables through effective management oversight and governance of the vendors.

• Responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Department He

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Valid through: 2020-1-20

About CSL Limited

CSL Limited is a global specialty biotechnology company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions. CSLs product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. Founded in 1916 the Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. Under the first director, William Penfold, CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Melbourne Hospital in 1918, before moving to its purpose-built Parkville premises in the following year. After ongoing disputes with the Commonwealth Department of Health and its director, (John) Howard Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. Soon after Morgans appointment, CSL was drawn into a serious public health disaster when a batch of its diphtheria toxin-antitoxin was implicated in the deaths of 12 children in what became known as the 'Bundaberg tragedy' of 1928. Although CSLs manufacturing processes were absolved, its labelling procedures were seen to be in error, leading to an enduring focus on the highest standards across the facilitys production. In 1928 CSL also became involved in antivenene (antivenom) manufacture in conjunction with the snake venom research undertaken by Charles Kellaway at the Hall Institute. This led to the successful clinical testing of antivenene against tiger snake Notechis scutatus bite in 1930, and its commercial release in 1931. In 1934 the research on snake venoms was transferred from the Hall Institute to CSL under the direction of former snake showman, Tom 'Pambo' Eades. This represented the initiation of research at the laboratories – an outcome its directors had been seeking for over a decade. The relationship with the Hall Institute continued until World War II, particularly via joint projects on viral diseases including polio and influenza coordinated by Frank Macfarlane Burnet and Esmond 'Bill' Keogh. Keogh played an important role in the establishment of penicillin production at CSL in 1944 – a critical wartime achievement.[citation needed] The operation commenced plasma fractionation in 1952. Thereafter the range of antivenoms increased, including those against other snake species such as death adder (Acanthophis antarcticus) and the taipan (Oxyuranus scutellatus), plus spiders including the redback (Latrodectus hasselti) and – after much difficulty – the Sydney funnel-web (Atrax robustus). Much of this work, including the introduction in 1962 of a polyvalent antivenom against all of the major terrestrial Australian snakes, occurred under the direction of Saul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicated Struan Sutherland.[citation needed]
Total Jobs:
53
Total Experts:
10
Average Pay:
$141,938
Total value of jobs:
$27,820,000
% Masters:
34%
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