Description

Job Description Summary
The Clinical Development Manager (CDM) provides clinical and scientific support to the development and execution of the clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. In addition, the CD Manager supports/leads the preparation of program level documents or activities, depending on the size and complexity under the supervision of the CD program responsible.

Job Description

Major accountabilities:

Your responsibilities include, but are not limited to:

• With appropriate guidance from (Sr.) CD(M)D or (Sr.) GPCH and dependent on stage the trial preparations / execution is in, provides clinical and scientific input, and contributes 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 the Clinical Development Plan (CDP); helps to develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meeting for Novartis local medical organizations
• With appropriate guidance from (Sr.) CD(M)D or (Sr.) GPCH coordinates clinical and scientific input and may contribute to clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  
  • In collaboration with appropriate Clinical Trial Team (CTT) members: a. Provides clinical support of trials as needed. Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) (CSE I/II) with appropriate oversight from Medical Lead. Manages 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. Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations with appropriate guidance from (Sr.) CD(M)D
  • With appropriate guidance from (Sr.) CD(M)D or (Sr.) GPCH, in line with the CDP, coordinates the development of program and study-level documents in collaboration with relevant line functions, including clinical sections of key regulatory documents such as Investigators Brochures, briefing books, safety updates and submission dossiers. May include writing sections of clinical trial documents for study CSR activities, publications, and registration dossier submission
• Supports the clinical team in rigorous adherence to GCP and regulatory standards by creating an inspection readiness working environment in close collaboration with CD Strategy & Operations and QA (e.g., development of trial-related storyboards)
• May contribute to global initiatives commensurate with experience (e.g., process improvement, training, SOP development, other CD, or enterprise-wide initiatives)

Minimum Requirements:

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, PhD, or recent participation in a Novartis Clinical Development Fellowship Program for at least 18 months strongly preferred
• 1-3 years of involvement in clinical research or drug development in an academic or industry environment in a clinical operations or clinical scientific role
• Strong scientific knowledge at least in one therapeutic area (e.g., basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcome)
• Working knowledge of GCP and drug development processes (e.g., clinical data collection & cleaning, ability to detect data trends etc.)
• Strong communication skills, written and oral
• Strong interpersonal skills to work in matrix environments

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $126,000 and $234,000/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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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.

Salary Range
$126,000.00 - $234,000.00

Skills Desired
Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis