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.
The Associate Director, Clinical Sciences supports US efforts in the planning, execution and reporting of Innovative Medicine US (IM US) clinical trials. This AD provides mentorship to Managers and Specialists, Clinical Sciences, to ensure that their role and contribution is optimized. This key role supports the development, management and tracking of trial budgets working closely with the appropriate partners.
Your responsibilities will include, but are not limited to:
• Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation, TMF maintenance, and organizing Ethics Committee submissions. May provide strategic input to protocol design based on operational feasibility and execution strategy as appropriate. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
• Serves as clinical trial leader for US Medical Affairs Trials (including Phase I-IV, Managed Access, Investigator Initiated, Research Collaborations and Registries). May serve as disease area(s) lead in support of Therapeutic Area Program Lead, Clinical Sciences.
• Interfaces with the disease area(s), global and US clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas. Liaises with study investigators, site research staff, and field-based colleagues to support clinical studies. Point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
• Organizes investigator’s start-up meeting and study site initiation meetings. Drives study enrollment, plan advisory boards, and perform external study feasibility with investigators. May independently develop strategic trial execution plan (e.g., recruitment retention, contingency plans) and timeline commitments for the US as appropriate.
• Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
• Responsible for the initial and subsequent drug supply across trials within a therapeutic area in collaboration with the Local Drug Supply Manager. Contributes to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
• Facilitates vendor selection and performance. Manages all vendors (CRO, Central lab etc.): definition of responsibilities, communication plan, divisions of responsibility, milestones, review monthly status reports, and the interactive management of all vendors to ensure project success.
• Coordinates the movement of laboratory samples and the resulting data when central laboratory facilities are used. Reviews all SAEs, ensures Medical Director sign-off, that sites are notified, and that all company procedures are complied with. Supports all scientific aspects of clinical trial(s) and program level activities as assigned.
The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to the East Hanover site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 5% travel.
The pay range for this position at commencement of employment is expected to be between: $151,200 - $226,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.
Diversity & Inclusion / EEO
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.
What you will bring to the role:
• Bachelor's degree, preferably in a science related field
• 8 years clinical research or research monitoring experience that provides the required knowledge, skills and abilities to mentor/train other clinical associates in a positive and effective manner.
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices, and applicable Standard Operating Procedures.
• Ability to evaluate medical research data and proficient knowledge of medical terminology.
• Solid presentation skills, good English language and grammar skills and effective oral/written communication skills, with the ability to communicate effectively with medical personnel.
• Strong customer focus, attention to detail, organizational and time management skills.
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software.
• Ability to utilize problem-solving techniques applicable to constantly changing environment.
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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
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
While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]