Clinical Research Medical Advisor

**Job Summary**
- Accountable for all country clinical/medical aspects associated with Development and prioritized Re
- search programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. May work across several countries.
- Gathers, informs, and acts on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation.
- Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.
- Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings.
- In close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) actively contributes to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.

**Responsibilities**:
Major Accountabilities

**From** **Strategy** **to** **Functional** **Excellence**

Provides Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned time
- lines:

- Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
- Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
- Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
- Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
- Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
- Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro
- grams/trials to ensure successful trial implementation, which includes:

- Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.
- Building disease area expertise, especially for new/rare indications
- Provides robust indication, compound, and protocol training:

- To the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed.
- Externally as needed in the Country/Cluster at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
- Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
- As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, HECOR, clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.
- Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
- Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.
- Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.
- Accountable for adherence to safety standards, clinical data quality for the Country/Cluster and pro
- vides general scientific/clinical/medical support for safety issues:

- Provides clinical/medical expertise to support pharmacovigilance activities.
- May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.
- Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertis