5 Medical Affairs Clinical Development Lead Jobs Hiring Near You

The Sr. Medical Science Liaison (MSL) is a trusted scientific partner and medical expert who provides strategic support and medical scientific expertise to healthcare providers as well as internal teams. Within assigned therapeutic areas, the Sr. MSL will provide product and scientific support for the organization that includes Medical Affairs, Clinical Operations, Sales, Marketing, Regulatory Affairs, to ensure maximum exchange of information and insights. The Sr. MSL is responsible for providing fair balanced, objective, scientific information, and education, both internally and externally. The Sr. MSL is focused on engagement with customers and Key Opinion Leaders (KOL) increasing awareness, assisting in matters that are complex, and exchanging scientific dialogue.

Within an assigned therapeutic area, provide support in the following ways:

• Medical affairs strategy:
  • Contribute to the development and implementation of the appropriate medical affairs strategy by providing  medical scientific expertise Contribute to organizing advisory boards/expert panels to improve scientific knowledge, identify unmet needs and cover potential scientific gaps.
• Medical affairs & scientific expertise:
  • Be the medical affairs and disease point of reference to internal and external stakeholders.
  • Build relationships and demonstrate the clinical outcome and benefits of company products to Key Opinion Leaders (KOL), medical groups and health systems.
  • Meet with local and regional thought leaders as frequently as is requested.
  • Drive the analysis of clinical trial data, prepare and report trial results at scientific meetings.
  • Respond to unsolicited inquiries to establish and/or further the knowledge and understanding of marketed products and related topics.
  • Make objective, fair balanced scientific presentations to external health care provider requestors and internal business partners.
  • Conduct all activities in accordance with current regulatory and health care compliance guidelines.
  • Provide high-level research support & investigator-initiated research. 
  • Stay abreast of current scientific and treatment landscape trends in therapeutic areas of interest.
  • Conduct ongoing dialogue with customers to understand KOL perspectives.
  • Conduct scientific exchange with institutional HCPs.
  • Provide medical support to Professional and Clinical Education team.
  • Respond to unsolicited scientific inquiries of Health Care Providers (HCPs)/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs.
  • Gather and report medical insights during interactions with health care providers.
  • Present data and information in a manner appropriate to the audience and request.
  • Actively participate in journal, and book clubs including scientific discussions on team calls.
  • Regularly share scientific news and findings with team.
  • Attend scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community.
  • Actively listen for and routinely documents and shares and medical insights.
• Scientific communication:
  •  Execute the development and implementation of the appropriate publication strategy in line with business objectives.

• Maintain a comprehensive and current knowledge of a therapeutic area (collection, evaluation and managing of scientific data) and drive the distribution of scientific information to respective stakeholders.
• Prepare literature for new products and revising existing literature.
• Assist clinicians in the preparation of scientific publications and presentations.
• Provide support in formulation of disease specific training & education strategies.
• Write and maintain files on informative journal abstracts according to current or estimated future needs. 
• Execute KOL management programs through advisory boards, expert panels and customer facing interactions. 
• Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development.
• Marketing department collaboration:
• Provide the medical and scientific expertise in the creation of promotional material events (e.g. product launch) and other activities such as tender business.
• Lead  literature review within a therapeutic area and translate evidence into comprehensive materials for marketing groups.
• Review marketing materials for scientific accuracy.
• Present scientific evidence at marketing events.
• Develop and maintain a medical plan that corelates with marketing and business plan.
• Clinical development planning:
• Contribute to the development of study designs, by being responsible for specific sections of the Clinical Investigational Plan (background and rationale of the study, selection of the endpoints, selection of in-and exclusion criteria, patient population and risk section).
• Evaluate scientific soundness of investigator-initiated trial proposals so that the BU can take an informed decision.
• Contribute to implementation of clinical protocols and perform writing of final study reports.
• Clinical operational activities:
• Support trial study start-up phases (support in writing study protocol, identification of investigators and KOLs, CRF review, Investigator brochure review, FDA/CA & IRB/EC assistance, support on medical and scientific questions/issues during trial follow-up phase).
• Review CEC/DMC/Clinical trial reports.
• Provide medical-clinical trial support to sites/investigators that are participating in the clinical research and participate in investigator launch meetings.
• Regulatory activities partnership:
• Work with regulatory affairs to ensure that all written documents are scientifically accurate and in compliance with applicable regulatory requirements.
• Support marketing authorization applications (reimbursement of medical devices).
• Perform clinical evaluations.
• Assist QS and engineering department in creation of risk management documents and IFU review.
• Participate  “subject matter expert” tasks to assure compliance with Terumo’s Quality System.
• Coordinate and provide reporting information for reports submitted to regulatory agencies.
• Perform all administrative requirements in a timely, accurate and compliant manner to include expense reports, documentation of activities. 
• Perform other duties as assigned.

• This position can be an office based or remote position. Must be able to work in office environment and in the field and requires up to 50% travel is required, including International trips. This role will combine both remote and in person communication with external and internal stakeholders so travel of up to 50 % is required 
• Daily entry to hospitals and other medical facilities is required. Many facilities have instituted vendor credentialing policies which require vendors to meet defined training, background check and proof of immunization requirements as a condition of entry. Terumo Associates entering these facilities are required to abide by these credentialing requirements. 
• Must be able to gain access to and work in the IR suite, cath lab and operating room. Entry into these areas requires an ability to wear appropriate gowning, stand for long periods of time, comply with hospital policy/protocol and be aware of potential biohazards such as blood borne pathogens.  

• Strong Scientific Acumen: In-depth scientific and/or therapeutic knowledge and experience in the assigned therapeutic area.
• Excellent Microsoft Word, Excel and PowerPoint skills.
• Ability to build strong relationships with relevant stakeholders, academic opinion leader.
• Excellent written, verbal and interpersonal skills.
• Ability to calculate the impact of actions or words and tailor approach.
• Ability to anticipate the responses of various individuals and teams based on their vantage point and perspective.
• Capacity to execute research initiatives and act as liaison between investigators and medical affairs.

• Advance Degree ((Ph.D., MD, Sc.D, MA/MS or MPH) in a medical/biomedical/scientific discipline with a minimum of 3 years of scientific experience; OR Bachelor’s Degree, preferably in life sciences with 7 years of relevant work experience; OR equivalent combination of education, training and experience.  
• Must have some research and health care system knowledge.