The 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 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. You will also be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. In addition, you may be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.
What you’ll be doing: Your responsibilities include, but are not limited to:
• Provide clinical leadership, medical and scientific strategic input, and contribute to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations.
• Provide clinical and scientific input and contribute 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 (CTT) members: Ensure clinical support of trials as needed; conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead; manage patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead; provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
• Support Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs, and support development of TA strategies, as needed.
• May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities.
• Contribute to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture; and may contribute to the performance evaluation of CTT members.
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training.
• Contribute to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).
This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely. This position will require 2% travel as defined by the business (domestic and/ or international).
Minimum requirements
What you’ll bring to the role: 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
Final job title (Associate Clinical Development Director/ Clinical Development Director) and associated responsibilities will commensurate with experience.
Why Novartis
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 [email protected] 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.
The pay range for this position at commencement of employment is expected to be between $201,600-$302,400 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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