The role is covered in the following locations: Baden-Württemberg, Hesse
Location: Ideally Heidelberg Germany
Other EU countries will be considered also.
Interact with European Key Opinion Leaders (KoL) in the field of monoclonal gammopathies and immunological disorders.
Work in alignment with and support the Clinical Affairs team to achieve organizational objectives (as directed by the Global VP Medical and Scientific Affairs Global).
Deliver clinical research strategies and contribute to the development and execution of clinical research programs related to scientific collaborations and regulatory submissions. Support study design, protocol development and implementation of clinical studies including late phase development. Maintain a systematic, compliant, procedure driven approach to scientific and registration studies. Monitor local regulatory environment to ensure compliance.
Translate evidence into scientific publications and/or marketing material in alignment with global strategic goals.
Review and evaluate the company clinical research results to determine marketability of products. Help explore new product ideas to assist in the identification of new scientific and marketing opportunities. Identify emerging medical and business trends, provide education and information to internal and external key stakeholders, utilize such information to influence and drive business strategy. Represent The Binding Site in professional organizations and at scientific events.
Working Environment: 38 Based at TBS Heidelberg / work from home. This is hybrid role with a requirement to travel throughout Europe and occasionally worldwide.. European and International travel required up to 30%.
Key Duties and Responsibilities
Internally: Interact with Medical and Scientific Affairs, Clinical Operations, Development, Applications, Raw Material Development, Verification, Clinical Research Associates, Statistics, Regulatory Affairs, Legal, Marketing, and Medical Science Liaisons, as well as General Managers and country-specific leadership teams of European geographies.
Communicate with each group regularly to ensure all stakeholders are up to date on the clinical study information relevant to them, including strategies, risks and progress. Interact with technical, regulatory and statistical contributors on the development of clinical study protocols, study reports, pre-subs, 510ks and other regulatory submissions.
Externally: Interact with health care professionals (clinicians and laboratorians), including global and local KoLs. Provide point of contact for B2B including pharmaceutical and academic partners, Independent Review Boards/Ethics Committees (or equivalent), vendors and suppliers, other collaborators.
Listen and get clarification; respond well to questions; speak clearly and persuasively in positive or negative situations.
Role Complexity: 43
Provide interpretation to and guide employees/stakeholders on compliance with relevant procedures. Contribute to updating procedures and/or creating new procedures in their relevant area to fulfill emerging business or regulatory needs.
Represent TBS in face to face KoL engagements. Represent the business best interest in open and direct communication while managing KoL relationships. Guide the team on how to extend TBS' KoL network. Ensure the balance between competing interests, such as study timelines, TBS priorities, and KoL expectations. Report progress against agreed timelines to the clinical study review board.
Able to discuss complex and innovative proposals in an easily accessible manner. Unify and present disparate concepts / assays to have a coherent "story".
Manage competing demands and change approach or method to best fit the situation. Able to anticipate and identify issues, implement solutions, propose corrective actions.
Work in complex situations, across departments and with external stakeholders.
Decision Making: 40
Expected to make decisions in their relevant areas independently, or with minor input. Able to analyze situations during KoL engagements and understand when the decision should be deferred.
Apply knowledge of the diagnostic area, TBS offering and interpersonal skills to resolve issues encountered in their areas relevant to the role.
Anticipate and identify problems, gather and synthesize complex or diverse information and use judgement to make decisions and resolve issues in a timely manner.
The position is responsible for projects that have significant impact on the timely and correct execution of the company's strategy and on the achievement of business goals.
The position has indirect impact on other departments' short term and long term goals and employees, due to interdependencies of this position with other departments and processes locally and globally.
People Management: 41
Peer to peer management of KoLs and ability to manage vertically as required.
"Dotted line" report for all European MSLs
Strive to continuously build knowledge and skills. Share expertise with others.
Freedom to Act:41
Actively search out issues and recommend solutions and is accountable for the success/failure of their decisions within Clinical Science Liaison
Financial Responsibility: 30
Understand budgeting, cost, and its impact on the company's profitability.
PhD in Biochemistry, Immunology or related subject
Masters Degree in hematology or immunology
Knowledge and Experience: 41
> 5 years of experience in medical device industry in medical affairs, scientific affairs or clinical affairs
Familiarity with GCP, ICH guidelines, ISO standards, FDA / IVDR regulations
In vitro diagnostic industry experience
Medical Devices/ Pharma experience will also be considered
Hematology/Oncology and/or Immunology expertise.
Strong relationships and engagement with clinical and laboratory professionals.
Collaborative thought leader in Hematology/Oncology and/or Immunology.
Clinical study/research experience with the ability to partner and build CRO/external partner relationships.
Track record of publications and presentations at international / national meetings.
Personal Qualities: Essential:
Ability to work independently and collaboratively in a fast-paced, complex work environment.
Problem solving skills.
Sense of ownership.
Look for ways to improve and promote quality; apply feedback to improve performance; monitor own work to ensure quality.
Continuous learning and skills development.
Sense of urgency.
Proactive approach to identify challenges and problems and take initiative to identify solutions.