Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employees contribution toward reaching our corporate missionto develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 09-0104

SUMMARY

Manage a team to provide Clinical Operations with services for process development (including Standard Operating Procedures [SOPs]), clinical outsourcing and training.

RESPONSIBILITIES

1.Manage, train, and develop direct reports to increase clinical research knowledge and professional skills to enhance contribution; set goals and appraise performance; plan and prioritize workload, assess capacity, develop staffing plans.
2.Partner with managers in Clinical Operations to define and prioritize training, outsourcing and process needs and gain alignment on team priorities, resources and strategy.
3.Maintain professional competence by attending conferences and training seminars as necessary and through self-study.
4.Ensure access to full process development services for Clinical Operations personnel, including:
(a)Development, review and maintenance of Standard Operating Procedures for Clinical Operations and coordination of work with stakeholders.
(b)Assistance with quality improvement and consistency efforts in Clinical Operations including ensuring current and appropriate SOPs.
(c)Compliance of systems and processes to regulations/guidelines and update of SOPs for changing requirements.
(d)Liaison between Clinical Operations and the CQA department for related or cross-functional processes.
5.Ensure access to full outsourcing services for Clinical Operations personnel, including:
(a)Support for selection and oversight of service providers, and coordination of work with stakeholders, including Legal, GCP Compliance, senior management, clinical teams and service providers;
(b)Development of outsourcing and contracting strategies to ensure attainment of effective services, enhance quality, minimize risk, contain cost, and identify and leverage opportunities;
(c)Monitoring of service provider performance and governance of service providers (business conflicts, issue resolution, improvement programs, project status, adherence to budget, periodic appraisals, etc.) in collaboration with BioMarin vendor stakeholders;
(d)Standardization of contracting processes and support for department process improvement measures and measurement systems;
(e)Compliance with purchasing policies and procedures, ethical practices, corporate values and relevant laws and regulations.
6.Ensure access to full training services for Clinical Operations, including:
(a)Standardized role-based training curricula and individual training plans for drug development related topics and BioMarin SOPS;
(b)Customized training and materials to meet business needs;
(c)In addition, for Clinical Operations personnel:
oEvaluation, feedback and recommendations on performance competency to individuals and their managers;
oNew employee orientation and mentoring for employee on specific training needs;
oManagement of a budget for training activities.
7.Other duties as assigned.

Requirements

EDUCATION

BS/BA in a scientific or medically related field desired, advanced degree or RN preferred.


EXPERIENCE

At least 6 years experience in Clinical Operations/GCP Compliance for a biotechnology or pharmaceutical company
At least 3 years managing direct reports
Excellent oral, written communication skills, as well as effective problem-solving and interpersonal skills
Ability to self-motivate and work independently to meet timelines
Expert knowledge of clinical study documentation, including monitoring requirements, FDA regulations, GCP/ICH compliance requirements, and operational aspects of clinical studies
Thorough understanding of the clinical drug development process
Excellent organizational skills
Attention to detail
Proficiency in software applications such as MS Word, Excel, etc.

To apply: Visit www.BMRN.com Job Code 09-0104