US-MA, Associate Clinical Development Director-Ophthalmology 218361BR-MZ
218361BR
Associate Clinical Development Director-Ophthalmology
Global Drug Development
CD&A GDD
USA
Cambridge, MA
Novartis Pharmaceuticals
Research & Development
Ophthalmics/Ophthalmology
Full Time
Regular
The Associate Clinical Development Director (Assoc. CDD) is responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.
1) Provides clinical leadership, medical and scientific strategic 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 Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations 2)Provides clinical and scientific input and contributes 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) 3) In collaboration with appropriate Clinical Trial Team (CTT) members: a) Ensures clinical support of trials as needed b) Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead c) 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 d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations 4) Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs 5) Supports development of TA strategies, as needed 6)May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities 7) Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members 8) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 9) Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).
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 strongly preferred
3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
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, written and oral
Strong interpersonal skills
Strong negotiation and conflict resolution skills
Proven ability to work independently or in a cross-functional team setting
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