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Associate Clinical Development Director

Band

Level 5


 

Job Description Summary

The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As a CDD in the Renal TA, you will have oversight of the clinical development for the assigned programs and drive the 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.


 

Job Description

Major Accountabilities

• Providing 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

Minimum Requirements:

• Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred***
• Fluent oral and written English
• Minimum 7 years experience in clinical research or drug development
• 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

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $152,600 and $283,400/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 


 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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 strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.


 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings



 

Salary Range

$152,600.00 - $283,400.00


 

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
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Average salary estimate

$218000 / YEARLY (est.)
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$152600K
$283400K

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What You Should Know About Associate Clinical Development Director, Novartis

Looking to take the next step in your career? Join Novartis as an Associate Clinical Development Director in East Hanover! In this role, you'll spearhead the strategic planning and management of our clinical programs within the Cardio Renal & Metabolic (CRM) Development Unit, providing influential oversight throughout the clinical development process. Your expertise will be pivotal as you collaborate with Global Trial Directors and various medical associates, ensuring that clinical plans are executed flawlessly. You're not just a leader; you're also an advocate for fostering a collaborative and empowered organization that thrives in a dynamic matrix environment. With your extensive experience in clinical research or drug development, you’ll guide the creation of crucial clinical documentation, oversee data integrity, and uphold the highest safety standards for our programs. At Novartis, you’ll have the chance to significantly contribute to scientific training and engage with both internal and external stakeholders, enriching the team’s knowledge and skills. If you possess a life sciences degree, have a knack for building relationships, and thrive in a cross-functional setting, this is your opportunity to make a real impact in the clinical development space. Let’s shape the future of healthcare together!

Frequently Asked Questions (FAQs) for Associate Clinical Development Director Role at Novartis
What are the responsibilities of the Associate Clinical Development Director at Novartis?

The Associate Clinical Development Director at Novartis is responsible for leading the strategic planning and managing the assigned clinical programs within the Cardio Renal & Metabolic Development Unit. This includes overseeing clinical deliverables, collaborating with Global Trial Directors, driving execution of the clinical program, and ensuring data integrity and compliance with safety standards.

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What qualifications are needed for the Associate Clinical Development Director role at Novartis?

To be considered for the Associate Clinical Development Director position at Novartis, candidates must hold an advanced degree in life sciences or a clinically relevant field, with a PharmD or PhD being strongly preferred. Additionally, a minimum of 7 years of experience in clinical research or drug development is required, along with strong communication skills and working knowledge of GCP and clinical trial design.

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How does Novartis support the professional growth of an Associate Clinical Development Director?

Novartis is committed to fostering an inclusive workplace that encourages professional development. As an Associate Clinical Development Director, you will have opportunities for scientific training, mentorship from senior leaders, and collaboration with cross-functional teams, all of which enhance your skills and expertise in clinical development.

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What is the salary range for the Associate Clinical Development Director position at Novartis?

The salary range for the Associate Clinical Development Director at Novartis, upon commencement of employment, is between $152,600 and $283,400 per year. This may vary based on geographical location, experience level, skills, and abilities, as well as other factors impacting final pay determinations.

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What kind of work environment can I expect as an Associate Clinical Development Director at Novartis?

As an Associate Clinical Development Director at Novartis, you can expect a collaborative and dynamic work environment where you will navigate a matrix organization. The company emphasizes empowerment, innovation, and open communication, allowing you to contribute effectively to the clinical development process.

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Common Interview Questions for Associate Clinical Development Director
Can you explain your experience with clinical trial design relevant to the Associate Clinical Development Director role?

In your response, outline specific projects where you led clinical trial design efforts. Discuss your strategy, key successes, and any challenges you faced, showcasing your understanding of clinical trial processes and your ability to adapt to regulatory requirements.

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How do you ensure effective collaboration across cross-functional teams?

To answer effectively, provide examples of how you've previously engaged with cross-functional teams. Highlight strategies you employed to foster communication and cooperation, as well as insights on how collaborative decision-making led to improved project outcomes.

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What steps do you take to ensure the safety and efficacy of a clinical program?

Detail your approach to safety management, including risk assessment strategies and your experience working with safety teams. Discuss how you leverage data analysis to monitor trial progress and ensure adherence to safety protocols throughout the clinical program.

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Describe a time you had to pivot a clinical development strategy quickly. How did you handle it?

Provide a specific example of when you had to change direction in a clinical strategy. Explain the circumstances that led to the pivot, how you communicated the change to stakeholders, and the ultimate outcomes of the new strategy.

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How do you handle disagreements with team members about clinical trial data interpretation?

Discuss your conflict resolution skills and your method for addressing disagreements professionally. Mention the importance of data transparency and collaboration, and provide an example of navigating such a situation successfully.

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What methods do you use to stay current with developments in your assigned disease area?

Speak about your commitment to ongoing education and research. Discuss how you engage with scientific literature, attend conferences, and network with industry experts to enhance your knowledge base in the relevant disease area.

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How important is mentorship in the role of an Associate Clinical Development Director?

Articulate your view on mentorship’s impact on team effectiveness and leadership. Share your experiences, both as a mentor and mentee, emphasizing how mentorship fosters a culture of learning and innovation within clinical development.

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What role do regulatory documents play in clinical development, and how do you contribute to their creation?

Explain your familiarity with regulatory submissions and the significance of these documents in clinical trials. Discuss your direct contributions, such as drafting or reviewing documentation, and your collaboration with other departments during the process.

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Can you share an example of how you've effectively trained stakeholders on a clinical program?

Provide a specific account of a training session or workshop you led. Highlight the objectives, the audience, and the outcomes achieved, showcasing your ability to communicate complex scientific information clearly and engagingly.

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Why do you want to work as an Associate Clinical Development Director at Novartis?

Be genuine in your response, expressing your appreciation for Novartis’ commitment to innovation and patient health. Mention how the company’s values resonate with your own and how you envision contributing to its clinical development goals.

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