Zusammenfassung
About the Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
