Clinical Development Director
- East Hanover, NJ
Clinical Development Director
(Associate / Senior) (80-100%)
Do YOU want to use your clinical expertise to help us reimagine medicine?
If the answer to the above is YES, then we would like to hear from you for current and future opportunities within our development units for:
Immunology Hepatology & Dermatitis
46'000! That's the number of patients in clinical trials at Novartis. Our vision in GDD is to engage these patients, making sure we have the right patients, in the right trials, at the right sites, at the right time
In Clinical Development & Analytics, our aim is to design innovative, patient friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems. To achieve this goal we rely on a dedicated team of experts, including the Clinical Development Director (Associate / Senior).
The (Associate/ Senior) Clinical Development Director (CDD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As (Associate / Senior) CDD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Main responsibilities of this role are:
•Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
•Leading development of clinical sections of trial and program level regulatory documents
•Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable
•Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
•Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety
•As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
•Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule.
•May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates.
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
•Advanced degree in life sciences / healthcare (or clinically relevant degree) is required.
•PharmD or PhD is strongly preferred
•Minimum requirement for years of experience in clinical research or drug development will be commensurate to level. (Assoc. CDD 3 years, CDD 7 years, Senior CDD 10 years)
•Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
•Demonstrated ability to establish effective working relationship with key investigators
•Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
•Strong communication skills with the ability to work in a cross functional and global organization required.
Final job title and associated responsibilities will be commensurate with the successful candidates' level of expertise.
Some restrictions to flexible working models may apply and will be discussed at interview if applicable.
WHY CONSIDER NOVARTIS?
799 million. That's how many lives our products touched in 2019. 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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