School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Business Development Associate III (2322)

Occupational Summary

The BDA III will demonstrate an in-depth knowledge of the Duke Clinical Research Institute (DCRI), including the capability to clearly articulate the role of an academic research organization (ARO), the role of the faculty, how we distinguish DCRI from our competitors, and the value DCRI brings to our customers. The BDA III will support national and international client relationships for clinical studies across all therapeutic areas by developing and facilitating the proposal/grant process for specific clients/sponsors. Responsibilities will include budget and pricing development, proposal writing, contract negotiations, and conduct of client presentations. The BDA III will also be a integral contributor to the development of the sales strategy for each opportunity.

Please see the BDA III PEP Evaluation Criteria for a further understanding of the detailed expectations of associated with a BDA III.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

Work Performed

Proposal and Proposal Revisions

• Develop proposals and proposal revisions to support investigator-initiated studies, industry-sponsored studies, government-sponsored studies, and studies sponsored by various foundations and professional associations.

• Formulate proposals and proposal revisions, with input from the Senior BDA as needed, in conjunction with various DCRI functional groups, Clinical Research Organizations, Academic Medical Centers, Site Management Organizations, and Duke Therapeutic Departments. Major components of the proposal development include the development of a budget and price estimate using standard models and development of well-written proposal text with corresponding assumptions, a compelling sales message, and a clear operational plan.

• Review all materials provided (i.e. protocol or study synopsis, client assumptions and specifications, etc.) and use this information appropriately to develop the proposal response.

• Coordinate and lead an Operational Planning Team (OPT) meeting, including all the appropriate Functional Groups (FGs), to devise the strategy/plan to develop the proposal response.

• Develop a budget and price estimate using the standard DCRI pricing model with the input of all the appropriate FGs.

• Appropriately challenge internal proposal/grant development teams (functional group and faculty representatives) in operationalizing each budget in the most efficient and cost-effective manner.

• Draft the narrative that ties the project components together.

• Package and present the final proposal to the sponsor.

• Communicate back to DCRI internal groups the outcome of the negotiations/proposals; conveying the expectations set forth for each group (i.e., clear details, critical timeframes, and expectations).

Grant Development

• Work with the Principal Investigator (PI) and project personnel to submit grant applications/renewals to the sponsoring institution.

• Coordinate grant development meetings (i.e., OPT meetings), working with participating functional groups to ensure the research is supported by an appropriate budget.

• Collect salary and effort information for project personnel through communications with departmental business managers.

• Develop budget and budget justification (to include detailed study assumptions) for input into Sponsored Projects Systems (SPS).

• Collect ancillary grant materials, including the required biographical sketches and “other support” pages, resources pages, letters of support, consortium statements of intent, and all appendices.

• Coordinate grant efforts with multiple subcontractors when applicable, including sites and other academic medical centers, to ensure the required budget documentation, letters of support, and other paperwork is received.

• Communicate with the Office of Research Administration (ORA) to verify that assigned grants in SPS are being reviewed, budgets and supporting documentation are complete and accurate, required internal forms are signed, and all grant materials are uploaded to www.grants.duke (when applicable) and conform to the sponsoring institution’s application guidelines.

• Upon grant award, update grant budgets to match actual award notice.

• Assist PI and study team in the development of the Research Plan (i.e., proposal) that includes a clear and executable operational plan. (Refer to the description under “Proposals and Proposal Revision” for the expected responsibilities associated with the development of the Research Plan development.)

Changes-in-Scope

• Develop changes in scope that accurately reflect all work to be performed outside the contracted scope of work.

• Document and explain change to the sponsor using clear well-written text accompanied by a budget grid that clearly delineates the new work from contracted work.

• For any work already completed that is outside the contracted scope of work, verify time tracking records correspond with effort provided by the F/Gs.

Financial/Contract Duties

• Develop cash flow analysis to determine the financial status of the projects throughout their duration. Using the cash flow analysis, work with Finance and other appropriate parties to determine the upfront payment needed.

• Develop final scope of work (SOW) once the proposal has been approved by sponsor.

• Participate in negotiations as part of the BD team, interacting with the sponsor after obtaining input and approvals as appropriate.

• Review final contract to confirm everything is correct prior to execution.

• Participate in the Executive Project Review meetings to review the financial status of projects, identify any possible changes in scope, and update Sr. Management on outstanding issues.

Client Management

• Interact with sponsors (industry and government) to discuss client expectations, discuss outstanding questions and/or concerns, etc, as needed.

• Participate in and/or coordinate client visits.

• Establish and maintain on-going client relationships to anticipate and resolve potential problems.

Other Duties

• Introduce and develop new proposal tools, processes and activities.

• Mentor other BDAs on the proposal development process.

• Participate in activities needed to support the management functions of the team.

• Attend industry trade shows and man the exhibit booth as needed.

• Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

MINIMUM HIRING SPECIFICATIONS

Education

Bachelor's Degree in business, science or other related discipline.

Experience

Five years experience in research and development arena (pharmaceutical company, CRO, etc.), with preferred experience in business development, proposal generation, review, and/or sponsor negotiations.

Excellent oral and written communication skills

Excellent presentation and public speaking skills

Excellent interpersonal skills

Analytical, problem solving, and negotiation skills

Knowledge of clinical trials process

Familiarity with NIH grant procedures

Willingness to travel (approximately 10% travel)

Excellent organizational, planning and prioritization skills

Willingness to attend training courses and trade shows (writing/editing courses, grants management courses, excel courses, industry trade shows, etc.).

Minimum Qualifications

Education

Bachelor's Degree in business, science or other related discipline.

Experience

Five years experience in industry business development and/or research and development arena (pharmaceutical company, CRO, etc.) with a minimum of two years experience in clinical research proposal generation handling at least 4 large, multi centered proposals with over $20M in direct costs. Prefer experience in review and negotiation too. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.