School of Medicine:
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The BDA I will support national and international client relationships for clinical studies across all therapeutic areas by developing and facilitating the grant/proposal process for specific sponsors/clients. Responsibilities will include budget and pricing development, compilation of required grant application documentation, and assistance with proposal writing.
Proposal and Proposal Revisions
- Assist in the development of proposals and proposal revisions for investigator-initiated studies, industry-sponsored studies, government-sponsored studies, and studies sponsored by various foundations and professional associations.
- Formulate proposals and proposal revision, under the direction and leadership of a Senior BDA, 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-writen proposal text with corresponding assumptions.
- With the assistance of a Sr. BDA, 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.
- Under the direction of a Senior BDA, 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 models with the input of all the appropriate FGs.
- Work closely with the Sr. BDA to 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; focus on conveying the expectations set forth for each group (i.e., clear details, critical timeframes, and expectations).
- Under the direction of a mentoring BDA, 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 details 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 reviewed, budgets and supporting documentation are complete and accurate, required internal forms are signed, and all grant materials are uploaded to grants. Duke (when applicable) and conform to the sponsoring institution’s application guidelines.
- Upon grant award, update grant budgets upon award to match actual award notice.
- Under the leadership of a Sr. BDA, 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.
- Develop final scope of work (SOW) once proposal has been approved by sponsor.
- Review final contract to confirm everything is correct prior to execution.
- In conjunction with the Sr. BDA, participate in the Executive Project Review meetings to review the financial status of projects throughout their duration, identify any possible changes in scope, and update Sr. Management on outstanding issues.
- Using the DCRI Enterprise Project Management (EPM) system, track and report on the status of all assigned proposals and change orders.
- Support other Business Development Team members and participate in activities as needed.
- Attend industry trade shows and man the exhibit booth as needed.
- Perform other related duties incidental to the work described herein.
Highly Preferred Knowledge, Skills and Experience
Two years experience in business development and/or research and development arena (pharmaceutical company, CRO, ARO, etc.), with particular emphases in grant and/or proposal generation and processes.
Excellent oral and written communication skills
Excellent interpersonal skills
Analytical, problem solving, and negotiation skills
Knowledge of NIH grant procedures
Knowledge of clinical trials process
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.).
Bachelor's Degree in business, science or other related discipline or Associate's Degree and related experience.
One year experience in industry business development and/or research and development arena (pharmaceutical company, CRO, etc.). Prefer experience in proposal generation, review, or negotiation. Must have experience supporting the development of at least six proposals to non commercial sponsors valued at $1M+ each in direct costs. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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