About Us :: Careers :: USA :: Senior Manager/Associate Director, Clinical Programs

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PRIMARY PURPOSE OF POSITION:

Develops and manages execution of operational strategies for an assigned program. Ensures clinical studies within a program are conducted in accordance to Good Clinical Practices (GCPs), regulatory requirements, and internal procedures. Ensures that appropriate strategies and plans are created for the program. Determines resource requirements and evaluates the need to outsource. Develops and monitors program budget, including partnering with internal and external groups. Manage personnel and external groups to facilitate the completion of studies in accordance to company goals.

This level manager receives assignments in the form of objectives and establishes goals to meet objectives. Incumbent manager provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect subordinate organizations.

Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

MAJOR DUTIES OF POSITION:

Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinate(s) to meet schedules and/or resolve issues.

Oversee clinical activities in executing assigned clinical studies. Ensures that clinical quality standards and practices are consistent across study programs. Resolves technical or logistical problems as needed.

Manage the overall conduct of clinical studies including site initiation, monitoring compliance with the protocol and GCPs, data collection and query resolution, site closeout, etc.

Identify, select, and/or manage contract research organizations (CROs), independent contractors, and other vendors. Obtain and evaluate proposals from CROs as needed. Ensures CRO adherence to the protocol, GCPs, scope of services, and overall clinical objectives.

Oversee the development and writing of clinical documents including protocols, investigator brochures, study reports, and annual reports. Ensures the preparation of all essential study documentation.

Develop and manage clinical study budgets and timelines. Ensures internal budgets, schedules, and performance requirements are met.

Supervise the activities of one or more direct reports (e.g., clinical research associates) to achieve study, clinical program, and company objectives.

Interacts with clinical peers and functional peer group managers to ensure clinical program needs and timelines are achieved.

Establishes and maintains effective working relationships with clinical study sites as appropriate, CRO personnel, and clinical consultants.

Participate as a project team member for assigned therapeutic area(s).

KNOWLEDGE AND SKILL REQUIREMENTS:

Bachelor/Masters degree or equivalent with at least 8+ years of progressive experience in clinical research development, preferably in a pharmaceutical or biotechnology setting.

At least 4 years of direct experience managing clinical studies and direct management of clinical staff.

Able to write and present professionally, clearly in a variety of communication settings and styles.

Experience in one or more of the following therapeutic areas: allergy, inflammatory disease, and/or infectious disease. Vaccine and NDA and/or BLA filing experience a plus.

Excellent organizational, problem solving, writing and editing skills are required.

Familiar with MSProject for development and update of clinical study timelines.

Ability to develop and update clinical budgeting models and spreadsheets.

Proven ability to establish collaborative working relationships in a team environment and possesses good training skills.

Negotiating capabilities and creativity in managing internal and external partners is important.

Working knowledge of data management/statistics as it applies to clinical studies is desirable.

Proficient computer skills, MS Office; Word, Excel, PowerPoint, and Outlook.

Must be willing and able to travel – approximately 25%.
Personal attributes including: integrity, flexibility, and action and goal oriented.

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