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Clinical Project Lead

Apply Now Job ID R-342959 Date posted 07/15/2019

Job Description Summary

Job Description

BD Diagnostic Systems is seeking an experienced Clinical Project Lead (CPL) in our Medical Affairs department located in Sparks, MD. This role is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area.  Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives and participating in critical product development decisions.  The Clinical Project Lead demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs, Quality, Business, or Project Management). The CPL is recognized as the MA technical subject matter expert across units or functions (for example, product development teams, business/unit or MA leadership teams). 

The Clinical Project Lead represents the interest of the patient and the health care worker and has advanced understanding of unmet medical/clinical needs, and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety. The Clinical Project Lead applies expert knowledge of clinical trial design and conduct of highly complex studies when interacting with extended clinical operations team, and is responsible for writing the Medical Affairs Strategy Document as well as the Clinical Trial Plan. The Clinical Project Lead has expert knowledge of local regulations and BD policies and procedures and advanced knowledge of BD products, product development process, ISO standards and elements of design control. The CPL will contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees.

Responsibilities also include developing clinical evidence plans including publication strategies.  The Clinical Project Lead will help coordinate and lead the team through journal publications and scientific conference presentations and represent Medical Affairs in market development activities.  The CPL will maintain relationships with Key Opinion Leaders and have an advanced understanding of product utility and links to potential patient outcomes.

Additional responsibilities may also include building operational functional excellence in product development and clinical research. The CPL leads MA responsibilities related to Health Hazard Evaluations by providing relevant medical/clinical input.  The Clinical Project Lead possesses critical thinking and analytical skills and is capable of evaluating research by processing complex data to arrive at conclusions.

The Clinical Project Lead may be responsible for indirect leadership of associates, including coaching and feedback. The CPL provides MA oversight and expertise to study teams, extended functional teams or work groups, inspires effective business/function dynamics, and imparts a sense of commitment to business/function goals.

Responsibilities:

  • Applies extensive technical expertise in a disease/diagnostic area or product/platform, and is recognized internally as technical or subject matter expert. Has in-depth knowledge of other related disciplines such as design control and product development, statistics and data management. Interprets and describes complex data.
  • Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims. Applies solid knowledge and experience in managing complex projects (possibly including multiple functions & outside partners), and is able to mentor/teach/interpret and create best practices with respect to tools & processes.
  • Manages multiple long-term projects without supervision. Interacts with manager as required by specific issues, milestones, or status changes.
  • Formulates short term planning and makes decisions for individual deliverables and contributes to long-term planning for business/function.
  • Develops and maintains relationships with key opinion leaders.
  • Develops and implements publication strategies in support of clinical evidence generation plans.
  • Creates complex, coherent, professional documentation and correspondence. Prepares formal written reports/documents for distribution within department. Able to present technical or complex information at a variety of levels depending upon audience. Confident and credible in discussions among peers, team members and Leaders of Business, and Function. Able to distill learnings from high-level /complex discussions and take appropriate action. Work product may require minimal review/input from strategic and technical point of view. Reviews the work of others such as technical, medical, regulatory and other documents.
  • Possesses full knowledge of applicable departmental, business, and corporate policies and procedures. Has operational knowledge of applicable regulations (including international regulations) as they apply to role and responsibilities. Is able to make appropriate functional comments to proposed guidelines and regulations on behalf of Medical Affairs, and is able to competently represent MA in regulatory strategies and interactions within BD (early/pre-IDE to submission/registrations), and to regulatory authorities and/or Standards Committees.
  • Develops components of a local or functional budget. Plans and budgets resources for complex or multiple projects. May recommend budgets and participates in process of gaining budget approval at function/business level. Carries out, adjusts, and oversees tasks and activities based on financial and budgetary considerations.
  • Independently develops training material requiring little or no review by others. Reviews training materials prepared by others. Trains others to deliver training. Creates and delivers expert presentations of complex material to wide-range of audiences, including Senior Management and external stakeholders.
  • Anticipates potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses and implements corrective and preventive actions with limited leadership input.
  • Identifies process improvement opportunities in own area of responsibility and in related areas. Capable of developing and executing improvement plan for consideration by wider team. Oversees implementation and tracks/reports metrics.
  • Responsible for indirect leadership (including managing milestones, status, issues, and coaching) of study teams or work groups in assigned program area.
  • Willingness to travel approximately 10% (domestic and international)

Education/Experience:

  • Bachelor degree required, with preferred education/experience focus in Clinical Microbiology, the life sciences, clinical, laboratory or other relevant technical areas.  Professional certification (clinical research, laboratory) is a plus.
  • Education and experience sufficient to demonstrate proven success as a subject matter expert in platform area of focus, or on functional teams across businesses/regions.  
  • Minimum  3 year experience in Medical Affairs, or as a functional Core Team member, or as a clinical project manager, with experience in managing multiple complex or multi-stage projects preferred.

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com