Clinical Project Director-Commercial

Location
Frederick, Maryland
Salary
Competitive
Posted
Jul 17, 2019
Closes
Aug 16, 2019
Ref
2170
Function
Executive, Director
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Clinical Project Director - Commercial located in our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Clinical Project Director will be responsible for managing one or more commercially-funded multicenter clinical trials. The Director must possess strong leadership, skill in managing personnel and projects, a strategic mindset, excellent communication and presentation skills, and a clear focus on delivery and client satisfaction to succeed in this role. Prior experience and a track record of success in leading and executing commercially-funded research studies is required. Experience with ophthalmology, transplantation or cellular therapy trials is preferred.

Responsibilities
  • Ensure that project deliverables in the assigned portfolio are negotiated with all stakeholders in support of; defined budgets, achievable schedules, quality standards and that the project is effectively managed in all areas of performance.
    • Develop successful working relationships with clients, executive management, and project staff
    • Track project deliverables using tools that support task and provide transparency to all stakeholders
    • Develop and ensure adherence to quality control and timetable for delivery of contractually required reports and deliverables
    • Manage project scope and resources (i.e., budget, personnel, and subcontracts), proactively identify risk and propose solutions; escalate issues if needed, to stakeholders as appropriate
    • Manage requests for out-of-scope activities; prospectively manage client expectations
  • Liaise with project managers and team members in portfolio management, staff training, and resource management including external contractors.
  • Serve as the primary point of contact for commercial clients; demonstrate proficiency in knowledge and understanding of client needs, risk mitigation strategies, and proposed solutions
  • Collaborate with Business Development, Contracts Department, and executive management to negotiate and ensure timely execution of contract amendments/change orders
  • Collaborate with other Research Unit therapeutic area leaders and lead business development, process improvements, and cross-project initiatives.
  • Model and propagate Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, value-added approach in collaborating with clients
  • Other duties as assigned

Experience
  • Master's degree in a scientific discipline and 8 years of demonstrated knowledge of scientific principles appropriate in managing a clinical research portfolio in the defined therapeutic area, including at least 2 or more years in a pharmaceutical setting, serving in a senior leadership role or equivalent position
    • Equivalent = bachelor's degree in a scientific discipline and 15 or more years of experience plus 2 or more years serving in a senior leadership role, will be considered in lieu of a master's degree.
    • Equivalent = bachelor's degree in a scientific discipline and 10 or more years of experience plus 5 or more years serving as a senior leadership role with commercial project expertise, may be considered
  • Prior CRO/pharmaceutical management of late stage clinical trials
  • Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost
  • Demonstrated experience in developing and fostering strong client and internal relationships
  • Thorough understanding of ICH GCP, HSP and relevant regulations and guidelines
  • Knowledge of project management processes and tools. Qualification in Project Management (PMI certification) or equivalent is desirable
  • Experienced in developing, implementing and managing budgets
  • Excellent verbal and written communication skills, planning, decision-making, negotiation, conflict management and time management skills
  • Skilled in MS Office Suite of products
  • Demonstrated experience in managing diverse staff and leading successful teams with d irect and indirect supervision responsibilities

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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