Senior Scientific Affairs Manager

United States of America, Indiana, Indianapolis

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Job Summary

Manages the day to day activities as Medical and Scientific Affairs counterpart for assigned business area(s) and corresponding scientific content in Medical and Scientific Affairs.  Establishes strong partnerships with medical thought leaders, investigators, authors, and internal cross-functional stakeholders.  Facilitates and develops the relationship with the medical/scientific community, by communicating product-related information to investigators and institutions consistent with Roche’s Good Promotional Practices.  Delivers critical scientific exchange including medical/scientific education and replies to unsolicited “off-label” inquiries in support of healthcare professionals, Roche scientific support groups and local and global business teams.  Supports the efficient planning, tracking and communication of key data.  Serves as a subject matter expert for a particular disease area, technology and/or assay.  Aligns with global/local marketing and Medical and Scientific Affairs in a gaps analysis and direct all study management of Investigator-Initiated and Roche-Sponsored Studies within their respective business area(s). 

Specialized and in-depth comprehensive knowledge and experience in a particular field, or business area.  Duties are varied and complex often involving research, analysis and solution development. Provides direction on issues of area of expertise and assist department leadership in setting strategic direction.  Typically a higher level professional position. Requires the regular use of originality and ingenuity.  Possesses and applies a broad knowledge of principles, practices and procedures of field. Is generally assigned more complex and difficult assignments.  Assignments are broad in nature. Typically works with greater discretion and latitude. May assist Consultants and lower level staff by providing advice and guidance.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Key Roles & Responsibilities

  • Facilitates and develops the relationship with the medical/scientific community, by communicating product-related information to investigators and institutions consistent with Roche’s Good Promotional Practices. Stays current on research developments, and new concepts in medical treatment and scientific technology, giving perspective to field activities associated with growing existing products, and bringing new products to market.
  • Builds relationships with thought leaders. 
  • Educates on key products to scientific and clinical customers.
  • Responsible for entire study strategy for the business area(s) they represent.  Responsible for coordinating alignment meetings with marketing and for executing gap-fill strategies.  Provides scientific / clinical educational presentations to customers. Represents Roche scientifically for their field of study (publications, presentations, advisory board meetings, focus groups).
  • Acts as high level resource for customers, sales and marketing.  Addresses customer’s scientific inquiries (on-label and off-label unsolicited requests), documents requests and actions, supports customer scientific and clinical applications.
  • Liaises with Global Medical and Scientific Affairs, product development, marketing, sales and operations teams to scientifically support commercialization of Roche products (e.g. scientific and clinical content development, etc.). Acts as single point of contact between Roche and advisers.
  • Responsible for advisory board identification, organization, implementation, execution and assessment.  Responsible for success of advisory boards.
  • Coordinates continuing education workshops, seminars, and training programs for graduate physicians, pharmacists, scientists and health and medical personnel.  Conceptualizes, organizes and analyzes data, interprets, and synthesizes complex clinical and non-clinical statistical reports to derive key outcomes and messages.  Translates scientific and technical issues for diverse audiences.
  • Attends appropriate U.S. and international scientific congresses, develops in-depth understanding of clinical practices and regulations, maintains understanding and insight into current lab and clinical practices and guidelines and investigates and reports internally on competitor technologies and products.

Minimum Qualifications

  • PhD in Chemistry, Biology, other natural science discipline or MD degree
  • 5 years of experience in Molecular Biology or equivalent
  • 2 years people leadership experience or related experience (project leadership)
  • Experience in working with senior business leaders, clinicians, and regulatory authorities
  • Knowledge of and compliance with laws and regulations, policies and procedures, guidelines for data dissemination and interactions with health care professionals 
  • Familiar with Roche Diagnostics products
  • Knowledge of diagnostic laboratory techniques and advanced skills in interpreting scientific/clinical data and in developing quality publications
  • Excellent oral and written communication skills including presentation, lecture, and teaching skills
  • Experience effectively managing multiple projects simultaneously in a timely and cost-efficient manner
  • Advanced computer skills including Microsoft Office Products

Preferred Experience

  • Experienced with clinical studies - Investigator Initiated & Sponsored (non-FDA registrational studies)
  • Experience supporting clinical lab testing