Senior Manager, Clinical Advisor

Job Summary:

Senior Manager, Clinical Advisor is responsible for developing and implementing the clinical advisory vision and strategy in alignment with Medical Affairs and the organization. This role will develop and manage a highly technical, impactful team that support specialized projects within Medical Affairs Scientific Data & Communication (SD&C) and broader organization. Will ensure medical, technical and scientific competencies are cutting-edge and current for Terumo. Senior Manager, Clinical Advisor will collaborate with and play a key role with internal teams, e.g., Research and Development, Commercial, as well as external stakeholders relevant for the business segment where Terumo is present, to include Physicians, HCP and other roles inside or connected with healthcare business in addition to patients.

Job Details:

People management:

Responsible for the development and direct management of a highly skilled and technical Clinical Advisory Group to include staffing, budgeting, training, development, coaching, regular face-to-face meetings, performance management, etc.

Responsible for oversight of the financial budget for the group and managing budget and resources efficiently.

Medical Affairs SD&C strategy:

Contribute to the development and implementation of the appropriate SD&C strategy by providing medical, scientific and technical expertise of a highly impactful team.

Medical Clinical Advisor strategy:

Responsible for the development and execution of the vision and strategy for Medical Clinical Advisor team.

Develops short-and long-term objectives and has direct oversight of the operational plan.

Medical Affairs & scientific / technical expertise (individual and for the team):

Act as the medical affairs and disease point of reference to internal and external stakeholders.

Build relationships and demonstrate medical benefits of company products to Key Opinion Leaders (KOL), medical groups and health systems.

Drive the analysis of clinical trial data, prepare and report trial results at scientific meetings.

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 & possibility for investigator-initiated research activites.

Stay abreast of current scientific and treatment landscape trends in therapeutic areas of interest.

Conduct ongoing dialogue with customers to understand their perspectives.

Conduct scientific exchange with institutional Health Care Providers (HCPs).

Provide medical support to Professional and Clinical Education team.

Respond to unsolicited scientific inquiries of 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.

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:

Overlook 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.

Organize the journal’s, and book’s clubs including scientific discussions on team calls.

Regularly share scientific news and findings with team.

Lead KOL management programs through advisory boards, expert panels and customer facing interactions.

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:

Contributor 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, Tand risk section).

Evaluate scientific soundness of investigator-initiated trial proposals so that the BU can take an informed decision.

Contributor 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:

Keep close partnership with medical writing team to ensure accuracy in all written given the highly medical, scientific and technical expertise of Clinical Advisor team.

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.

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 requires regular travel to customer sites, TMC sites, congresses, and 3rd party sites

Must be able to drive personal automobile to/from customer accounts and drive long distances as necessary.

International travel and occasional weekend travel may be required.

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

Excellent written, verbal and interpersonal skills.

Strong people management skills.

Ability to build strong relationships with relevant stakeholders, academic opinion leader.

Strong Scientific Acumen: In-depth scientific and/or therapeutic knowledge and experience in the assigned therapeutic area.

Advanced product and therapy knowledge.

Excellent Microsoft Word, Excel and PowerPoint skills.

Ability to transfer complex scientific information to relevant stakeholders inside the organization.

Advanced impactful presentation skills.

Highly customer and market focused with ‘big picture’.

Ability to work effectively in a matrix environment.

Ability to calculate the impact of actions or words and tailor approach.

Ability to execute all activities and initiatives in compliant manner with a high level of integrity.

Ability to anticipate the responses of various individuals and teams based on their vantage point and perspective.

Background Experiences

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 in a medical device/clinical environment required with a technical or professional health services licensure from an accredited licensing entity strongly preferred (e.g., RT, RCIS, RN); OR equivalent combination of education and experience.

At least 3 years of prior people management experience required.

Must have some research and health care system knowledge and experience in product life cycle management, design history, product support specialist strongly preferred.