Sammanfattning
About the Role
Key responsibilities
- 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:
- Proactively 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 en-gagement.
- 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, 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, patients, and payers, with internal Stakeholders at the Country/Cluster level with the goal to optimize clinical trial implementation.
Essential requirements:
- Scientific degree M.D., Ph.D., or Pharm.D. (M.D. highly desirable);
- 3 years of clinical development experience in the pharmaceutical industry or clinical practice;
- Good knowledge of the clinical development process, and ICH/GCP principles;
- Subspecialty training and/or RWE experience desirable;
- Fluent in Czech and English;
- Ability to manage a study from the scientific/medical/clinical perspective, 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;
- Willingness to travel up to 50%, including Internationally, as needed.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
Handbook.https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
