Key Responsibilities:

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 timelines:

• 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
• Provides robust indication, compound, and protocol training:
• 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., Clin- ical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, HE&OR, 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, pa- tients, 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 Regu- latory 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.

Essential Requirements:

• University degree in MD, PharmD, RNDr, MVDr. or other life sciences
• Native Czech/Slovak
• Proficient in English
• Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.
• Sound understanding of the overall clinical development process, and ICH/GCP principles.
• Ability to manage a study from the scientific/medical/clinical perspec- tive, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
• Ability to lead effectively by communicating well, motivating a cross- functional team, and handling and delegating responsibilities.
• Agility to move quickly across different therapeutic areas and indications.
• Demonstrated problem-solving skills and comfort with complexity.
• Ability to prepare and deliver high quality presentations.

Travel requirements:

Willingness to travel up to 50%, including Internationally, as needed

You’ll receive:
• Competitive salary along with a yearly bonus.
• Monthly pension contribution matching your contribution up to 3% of your gross monthly base salary

• Company car
• Risk Life Insurance (full cost covered by Novartis)
• 1 week holiday above the Labour Law requirement
• 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report
• Cafeteria employee benefit program – choice of benefits from Benefit Plus SK for 500 EUR per year
• Meal vouchers of 6,50 EUR each working day (full tax covered by the company)
• MultiSport Card contribution