Drives development of project level goals that contribute to the overall goals of R&D and drives execution of the program in a manner that achieves delivery of the goals/objectives and the agreed plan without compromising project deliverables or relationships Leads and facilitates data needed for decision analysis with the team including development and assessment of outc

Provides strong scientific support to the overall chemical development team to ensure that the development plan provides for rapid and innovative process development and scale up of drug substances incorporating quality, safety, compliance, cost effectiveness, sustainability, and reliability to meet development and commercial requirements Lead contract development organiz

Leads clinical study teams and represents clinical operations on multi function project teams internally/externally. Assists in the design/review of clinical protocols, informed consent documents, and trial case report forms. Leads all aspects of external vendors, including but not limited to contract research organizations (CROs) and Clinical Research Associates/Assistan

Impact customers by providing valued services, applying approved marketing and corporate resources to help providers identify and begin appropriate patient therapy. Apply knowledge, critical thinking, and dialogue skills to deliver substantial customer experiences that result in satisfaction, equity, and loyalty. Develop positive relationships that facilitate mutual respe

Impact customers by providing valued services, applying approved marketing and corporate resources to help providers identify and begin appropriate patient therapy. Apply knowledge, critical thinking, and dialogue skills to deliver substantial customer experiences that result in satisfaction, equity, and loyalty. Develop positive relationships that facilitate mutual respe

Shares expertise regarding CDISC/industry standards Advises SAS Programmers on producing submission datasets and related documents Creates or QCs programs for generating datasets, tables, listings and figures Constructs integrated datasets across multiple clinical trials Performs vendor qualifications in regards to statistical programming functions and manage CROs regardi

Establish strategic plans for designated function(s) and participate with senior management to align objectives across the organization. Develop early clinical development plans including study designs, and associated protocols t for all phase I studies Design, plan and implement biomarker strategies to inform indication priorities, commercial differentiation, target enga

Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success. Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets. Represents the regulatory func