Associate Clinical Development Medical Director, Respiratory

Job Description

12,000! The number of global drug development associates worldwide. We are courageous in developing transformational medicines to address the unmet needs of patients. As an Associate Clinical Development Medical Director (Assoc. CDMD), you will join the respiratory and allergy team, who are committed to helping patients.

You will be responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data and clinical development programs, depending on the size and complexity.

Your responsibilities will include:
• Clinical leadership, medical and scientific input, and contribution to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) consistent with Integrated Development Plan (IDP). Developing materials for advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis medical organizations
• Contribution to clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• In collaboration with appropriate Clinical Trial Team members, ensure direct medical support of trials as needed and may act as medical monitor. Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s), lead patient safety and report on trial data to safety boards (e.g., Safety Management Team, GCT, GPT) and provide input into analyses and interpretation including the development of the Clinical Study Report(s), publications and presentations
• Under the direction of the (Sr.) GPCH or (Sr.) CDMD contribute to ensuring overall safety of the compound for assigned trial(s) with Patient Safety
Participate in developing talent and careers of Clinical Development associates through on-boarding, coaching, and/or mentoring support; develop and champion Clinical Development culture; and may contribute to the performance evaluation Team members

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

What you’ll bring to the role:
• MD or equivalent medical degree required. Sophisticated knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) preferred
• Solid understanding of the disease area with validated ability to interpret, discuss and present efficacy and safety data relating to trial(s) at program level
• Previous experience of clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Proven ability to establish effective working relationship with partners
• Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Proficient oral and written English skills

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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

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