Senior Medical Affairs Specialist Radiation Oncology

Senior Medical Affairs Specialist Radiation Oncology

Job Category: Clinical & Medical
At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people’s health and patients’ wellbeing? We’ll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations – live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates.

Department Info
This position is within the new Therapeutic Interventional Oncology (TIO) Organisation of Terumo. It is entirely dedicated to offer innovative therapeutic solution to cancer patients. This organisation is comprised of Research & Development, Medical Strategy, Software & Imaging Solutions, and Operations (incl. Manufacturing & Supply Chain)
The objectives of the Global Medical Strategy TIO Radiation Oncology department are:

• To define a Global IO therapeutics medical development strategy in the radiation therapeutic field.
• To design, develop, and support effective execution of clinical trials
• To maintain compliance of company products with regulatory requirements ensuring business continuity
• To maintain deep medical expertise in the IO technical and therapeutic field including all therapeutical solutions.
• To communicate clinical data to a wider multidisciplinary oncology audience,
• To manage all medical aspects of company products in radiation oncology
• To contribute to new product and new therapy development.

Job Summary
A Senior Medical Affairs Specialist Radiation Oncology encompasses very strong scientific, informational, communication and interpersonal activities, and works with a range of different departments (e.g. clinical operations, marketing, regulatory affairs, product management and R&D) within the company in order to ensure maximum information exchange and development. The role has a global dimension requiring a multicultural and strategic mindset. Outside customer contacts are frequent and related to more complex matters. In this ‘upstream’ Medical Affairs role, focus is on addressing unmet needs with KOLs and contributing to the global clinical trials strategy. As a senior member of the team, you share best practices and experience with more junior colleagues.

Job Responsibilities
Medical affairs & scientific expertise:
Be the disease expert for the assigned therapeutic area for internal and external stakeholders
Provide recommendations on future clinical trials/area of interest in line with Global TIO strategy and competitive clinical trials landscape
Analyse clinical trial data, prepare, and report trial results at scientific meetings.
Deliver/perform scientific support during study execution

Scientific communication:
Support maintaining a comprehensive and current knowledge of a therapeutic area (collection, evaluation and managing of scientific data) and distribute scientific information to respective stakeholders (both internal and external).
Provide support in formulation of publication strategies, including data dissemination plan, preparation of scientific narratives and support of value proposition.

Supporting marketing:
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
Provide support in formulation of disease specific training & education strategies.

Clinical Development planning
Support development of Clinical Investigation Plans (CIP)
Deliver evaluation of the scientific soundness of investigator-initiated trial proposals so that the medical affairs lead can take an informed decision.

Clinical operational activities
Support trial study start-up phases (support in writing study protocol, CRF review, Investigator brochure review, CA&EC assistance, support on medical and scientific questions/issues during trial follow-up phase).
Review CEC/DMC/Clinical trial reports
Support in safety reports of Clinical Investigation (CI)
Medical review and assessment of reported adverse events

Regulatory activities:
Work with regulatory affairs to ensure that all written documents are scientifically accurate and in compliance with applicable regulatory requirements.
Drive and support the introduction of our medical devices in new markets worldwide, including activities to obtain reimbursement in various countries
Support marketing authorization applications (reimbursement of medical devices).
Perform clinical evaluations.
Define and coordinate Post Market Surveillance, including Post-Market Clinical Follow up activities
Give support to subject matter expert role to assure compliance with Terumo’s quality system.

Profile Description
You have a master’s or PhD degree in a relevant discipline (e.g., biotechnology, biomedical engineering, medicine, technical medicine) Radiation oncology, nuclear medicine experience is a strong asset.
You have at least 5 years of Medical or Clinical Affairs experience in pharmaceutical or medical device industry in oncology. This includes experience in managing international medical device studies (sponsored and/or IIS), protocol writing and designing key study documents.
You have effective project management skills, cross-functional team leadership and organizational skills
You feel comfortable working in an international environment, you work collaboratively across the organization and with others to reach results.
In addition, you can travel up to 20% across the world
You have interacted with KOLs and/or have medical society management experience
You have an analytical mindset, can think strategically and are a solution finder. You can navigate a certain level of ambiguity and can help shape our growing global organisation.
Excellent level of English is a must, other languages are a plus.

Offer
We offer a unique, full time, opportunity to contribute to the fight against cancer and bringing new treatments closers to patients.
You will work in a very dynamic and growing environment, expanding our activities in Europe and soon in the rest of the world! You will be coached by your manager Rijk, Global Medical Strategy Director TIO Radiation.
You can count on a compensation package that includes a competitive salary, benefits and access to a large learning and development offering.

Contact Person
Jan Swinnen
Talent Acquisition Lead EMEA

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

Job Type: Full-time

Education:

Experience:

• Med. or Clinical Aff. in pharm. ical or medical device ind.: 5 years (Required)
• effective proj. management skills: 1 year (Preferred)
• Cross functional team leadership skills: 1 year (Preferred)
• Managing international medical studies: 1 year (Preferred)

License/Certification:

• Master or PhD biotechnology al engineering (Required)
• Radiation oncology and/or nucleair medicine experience (Preferred)

Willingness to travel:

Work Location: Hybrid remote in 7418 AH Deventer