Associate Executive Director, Clinical Materials Services Unit

Rochester, NY

GENERAL PURPOSE:

To provide on-site leadership and management of the overall operations of the Clinical Materials Services Unity (CMSU), consisting of approximately 15 team members, with two Directors (Director Operations and Director Quality Assurance) and the clinical trials it supports in North America. This role will oversee teams and ensure maximum operational efficiency, resource utilization and overall regulatory and cGMP compliance with all applicable state and federal regulations, licensing requirements, and professional standards pertaining to secondary packaging, labeling, blinding, distribution and return services of clinical supplies (drugs and devices).

SPECIFIC RESPONSIBILITIES:

We are looking for someone interested in guiding the CMSU to be a pioneer in the future of clinical trials drug packaging and distribution. This role will research and evaluate the changing national and international marketplace related to scientific trends and competitive solutions and will translate knowledge of the business and services to meet strategic goals. Specific responsibilities include the following:

  1. Establish and cultivate relationships with and market services to potential customers including academic, non-profit/foundations, government, and biopharmaceutical companies. Represent the CMSU to professional organizations, in cooperative programs with other institutions, sponsors, entities or funding negotiations with public or private organizations

  2. Oversee all aspects of operations, including operations, quality assurance, facilities, finance and administration, project prioritization, resource allocation, and day-to-day operations efficiency

  3. Set and implement the overall direction of the CMSU in conjunction with the Executive Director, its growth and diversification strategy, including prioritizing CMSU projects and resource allocation, responses to requests for proposals for projects from any potential sponsor, management and administration of other operations (e.g., prepare analyses and reports, make recommendations for programs and policies, etc.).

Drive key strategic initiatives, including:

  1. Recruiting, developing, training, and retaining strong talent

  2. Driving improvements in infrastructure, technologies, operating systems, and processes

  3. Developing and executing strategic technology roadmap that enable efficient operations

  4. Delivering transparency into operations – e.g., self-serve reporting for client, timeline/resource dashboard to manage project timeline & optimize resource allocation

Work with department’s Financial Manager and finance and administration teams to monitor and evaluate overall CMSU finances, including project scope and budgets, change orders/contract amendments, and overall resources (personnel and space). In collaboration with Financial Manager, prepare, recommend and control budgets; prepare long range forecasts; approve expenditures, and reallocate funds. Management of the performance and productivity of CMSU Functional Directors.

Additional projects and responsibilities as needed including but not limited to serving as a key member of the CHeT leadership team to discuss operations and logistics

REQUIREMENTS:

  1. Masters degree or higher in health or life sciences related field, pharmacy, business administration, or equivalent experience in a specialty suited to the position

  2. A minimum of 8 years’ experience in clinical research, biopharma drug development, and/or healthcare industry experiences. At least 10+ years of experience in the industry strongly preferred.

  3. Minimum of 8 years of proven, effective strategic planning; analytical problem solving and decision making; managerial and leadership skills and experience; or equivalent combination of experience and education

  4. Ability and knowledge to discuss scientifically with biopharma R&D/Medical Directors/Clinicians/PIs, commercial/operational experiences with biopharma(s) with relationships/connections in the clinical research industry/associations are preferred

  5. Strong understanding of regulatory requirements (e.g., GMP, GCP, HSPP, ICH) and Audit readiness

  6. Prior experiences serving as Principal Investigator for clinical studies is a big plus

  7. Strong analytical and finance administration knowledge with managing budgets

  8. Strong organizational, interpersonal, presentation and communication skills, including written communications

  9. Strong acumen to understand and drive adoption of technologies, in particular clinical data management, data visualization, and statistics in clinical trials preferred

  10. Ability to model leadership skills of professionalism, positive attitude, team building, good judgment and respect

  11. Ability to manage multiple projects, organize and prioritize work and perform several tasks simultaneously to meet deadlines and work effectively with people at all levels of the organization

Interested individuals should apply on-line to Job posting #241326 at http://www.rochester.edu/working/hr/jobs/

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

The University of Rochester is responsive to the needs of dual career couples.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $50,000 - $150,000 Annually

The referenced pay range represents the minimum and maximum annual salary for this faculty position. Individual salaries will be determined within the job’s salary range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Incentive-based compensation may also be applicable and will be discussed during the hiring process.

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