Associate Clinical Development Medical Director

Novartis • East Hanover, NJ

1d

About The Position

The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity. MAJOR ACCOUNTABILITIES: Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program. Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions. Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety. Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to medical/scientific training of relevant Novartis stakeholders. May serve as speaker for franchise medical/scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Requirements

• MD or equivalent medical degree required
• Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred
• Clinical practice experience ≥ 4 years (including residency) 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 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

Nice To Haves

• 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

Responsibilities

• Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring
• Responsible for the scientific and medical strategy of assigned sections of a clinical development program
• Contributes to the development of clinical sections of trial and program level regulatory documents
• Contributes to the execution of the section of the clinical program in partnership with global line functions
• Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety
• Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas
• Contributes to medical/scientific training of relevant Novartis stakeholders
• May serve as speaker for franchise medical/scientific training
• Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
• Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree