Sr. Mgr/Assoc Director, Global Monitoring, West Coast - Los Angeles, CA, United States - Incyte Corporation

Description

Overview

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

The Associate Director is responsible for Regional Monitoring leadership, strategic planning, and operational delivery of clinical development programs to support Incyte's pipeline and corporate objectives. The Associate Director of Global Monitoring is responsible for the regional oversight and management of Managers, CRAs, Monitoring CTSs, FSP vendors and assigned clinical development programs.The experienced Associate Director anticipates, identifies, and resolves high level complex management issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting personnel, analytical methods and techniques, and decision-making, the Associate Director will establish strong, positive relationships for Incyte with both internal and external partners. These individual initiates the selection, development and/or implementation of efficient and effective approaches to managing clinical trials and monitoring personnel.

Essential Functions of the Job (Key responsibilities)

Develops and maintains strong collaborative relationships with Regional internal and external partners.

Line or functional manage Monitoring Team, identifies areas for new training or skill checks, and develops strategies to promote team member adherence to company procedures, standards, and performance goals.

Accountable and oversees regional In-house and FSP vendors resources, responsible for or assist resourcing / allocating CRAs to studies to ensure project needs are met.*

Identifies gaps in process(es) and is accountable for the development and implementation of solutions.

Continuously and proactively incorporates learning and recommendation, identifies, and proposes solutions for process improvement opportunities to Monitoring Senior Management and communicates best practices to entire monitoring staff. Collaborates with Reco/Clinical Operations and Development Operations leadership to identify local/country gaps and initiate /create/ improve local process(es)

Ensures Monitoring Team receive therapeutic and project-specific training.

Collaborates and Support internal audits and regulatory inspections, to ensure inspection readiness and implementation of Corrective Action Plan for assigned studies.

Ensures that Global Monitoring SOPs, processes and guidances are aligned with ICH-GCP, Declaration of Helsinki, local and global requirements, remaining current with local laws, regulations and guidances.

Provides oversight and counseling for CRA performance issues

Reviews CRA and Sr. CRA monitoring metrics to ensure they are meeting Key Performance Indicators (KPIs):

o Assist in site selection.

o Regulatory document collection and review.

o Overall scheduling and management of all site visits.

o Development of site/monitoring tools and training materials.

o Assist in identifying trends in enrollment and data entry at sites and proactively interface with clinical monitoring team to identify solutions

Accountable and oversees regional monitoring initiatives and strategies. Work closely and in collaboration with ADCO within development Operations, in countries where applicable

Ensure Incyte's SOP, working documents are followed by global monitoring; awareness of changes required by regions Represents department on cross-functional improvement initiatives, committees, working streams and governances.

Identify candidates for regional positions, support candidate recruitment, and utilize effective interviewing techniques to ensure judicious hiring choices.

Qualifications (Minimal acceptable level of education, work experience, and competency)

BA/BS preferably in Life Sciences

At least 5-7 years of experience in Development Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management.

Direct management experience and supervisory responsibility at least 5 years. Demonstrated leadership and management skills.

Demonstrated organizational and communication skills

Extensive knowledge of Monitoring, including FDA and international regulations, GCPs, clinical trial design and documentation, and conduct of clinical trials.

Experience in working in a global matrix organization

Excellent interpersonal, organizational, and problem-solving skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.

Strong communication skills (verbal and written) to express complex ideas

Goal oriented, self-starter with proven ability to work independently.

Able to proactively identify issues and provide solutions for resolution.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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