B. Braun

  • VP, Medical Scientific Affairs

    Job Locations US | US-PA-Breinigsville
    Requisition ID
    2018-12095
    Company
    Aesculap Biologics
    # of Openings
    1
    Category
    Clinical
    Position Type
    Regular Full-Time
    Shift
    8 a.m. to 5 p.m.
    Site
    Aesculap
  • Overview

    Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body’s own regenerative power to improve the quality of patients lives. 

     

     

     

    Responsibilities

    Position Summary:

     

    Lead, develop and continually refine Medical Scientific Affairs infrastructure and program operations to ensure high quality clinical science. Work with cross-functional and interdivisional teams within and across BBraun companies to align clinical science strategy, processes, and product development plans as related to Medical Scientific Affairs at Aesculap US.

     

    Oversee operational aspects of all Aesculap US clinical studies (IND/BLA, IDE/PMA, investigator initiated studies, and post marketing studies) and provide strategic direction for clinical trial operations through the direct management of the clinical research staff.

     

    Responsible for the development and implementation of clinical research processes and systems as well as providing leadership, training, coaching and mentoring of the clinical research staff.

     

    Responsibilities: Essential Duties

    • Develop and implement clinical operation strategies to support local institutional priorities. If possible, align research plan with global strategies to ensure compliance and efficiency for all business units.
    • Staff and develop clinical research personnel, including resource utilization, staffing projections including on-boarding/training, etc. Responsible for building clinical study teams   based on project and company timelines.
    • Ensure clinical research staff is trained and trials are executed according to company procedure, local, federal and appropriate ethical, regulatory, and quality standards.
    • Assist and participate in other Medical Scientific Affairs projects and/or clinical studies, including clinical trial design, as required including managing/developing product development plans, CSRs, and other reports and communications to the FDA.
    • Ensure appropriate and timely reporting of clinical data, including safety data to appropriate parties, according to company and local procedures.
    • Ensure that clinical research is cost effective by analyzing internal and external costs, including resource utilization and performance data.
    • Negotiate and establish contracts with external resources (Clinical Research Organizations – CROs).
    • Manage Medical Scientific Affairs budget.
    • Must be able to author Clinical Investigational Plans
    • Report updates to executive management and/or therapeutic leads/team on regular basis. Meet with cross-functional teams regularly to assist in distributing work in a proactive basis.
    • Identify emerging trends and regulations in clinical research and integrates these changes into policies and procedures
    • Must comply with applicable GCP, ISO and FDA regulations
    • Must embody the Company’s Vision, Mission and Values
    • Other duties may be assigned

    Expertise: Knowledge & Skills

     

    Secondary or peripheral job functions: 

    • Must be able to travel by air and car and work occasional weekends – travel required 50-70
    • Requires strong written, oral, interpersonal, group and telephone communication skills.
    • Computer skills in Windows, Lotus Notes, Microsoft Excel, Powerpoint and Word
    • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe work environment for all employees.
    • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to effectively present information to top management, public groups, and/or boards of directors.   
    • Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. 
    • Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

    Supervisory Responsibilities: 

    • Manages the professional development, training, and education of clinical studies group staff.
    • Organizes and prioritizes assignments for clinical studies groups.   

    Qualifications

    Expertise: Qualifications-Experience/Training/Education/Etc

     

    Required:

    • MD, DVM and/or PhD in biological sciences or other related field required.
    • 20 years minimum experience of study management in clinical research
    • 15 years minimum of management experience leading a clinical group including clinical/medical affairs and clinical operations.
    • 15 years of experience in the drug, biologic and device industry preferred.
    • A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s, IDE’s and marketing approval-directed filings (BLA’s, PMA’s NDA’s)
    • Excellent interpersonal skills and the ability to work and manage effectively in a team environment.
    • Highly organized with the ability to manage complex projects.
    • Technical writing and medical writing experience.
    • Must be able to create and present technical/analytical data to surgeons.
    • Must be able to organize work and manage multiple priorities.
    • Analytical skills needed to conduct research, analyze data and write technical and/or legal documents.

    Desired:

    • N/A

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds.

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

    Other

    Responsibilities: Other Duties:

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

    Physical Demands:

    • The employee must occasionally lift and/or move up to 30 pounds. 

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Work Environment:

    • This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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