Clinical Development Medical Director

Novartis Services Incorporated Clinical Development Medical Director East Hanover , New Jersey Apply Now Job Description SummaryAs a Clinical Development Medical Director - Rheumatology, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. Job DescriptionJob DescriptionThe Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g., submission activities, briefing books, clinical study reports, etc.) and / or a large, complex trial, under the leadership of the Global Program Clinical Head (GPCH). May also lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).Major accountabilities : Provide clinical leadership and medical strategic input for deliverables in the assigned project / program. Deliverables may include sections of individual protocols consistent with the clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents / registration dossiers, and publications (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities)Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors, and regional / country medical associatesOversee / conduct medical and scientific review of trial data with Clinical Scientific Expert (CSE). May be the Program Manager of other associates (e.g.., CSE). May function as study medical monitorSupport GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team, and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient SafetySupport the Clinical Development Head by providing medical input into CDP and clinical trial package reviews and contributing / driving development of disease clinical standards for disease areasProvide support to the GPCH or CDH in interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., clinical trial team, Medical Affairs, Commercial, Health Economics & Outcomes Research), and decision boards)Work with BR (Novartis Biomedical Research) / Translational Medicine) to drive transition of early development projects to Transition Decision Point and with Business Development, including target identification and due diligencesEnsure career development of Program Reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring supportContribute to medical / scientific training of relevant Novartis stakeholders on the disease area and compound / molecule. May serve as speaker for Global Clinical teamMinimum Requirements : MD (or equivalent medical degree) required. Training in Rheumatology preferred4 years Clinical practice experience (including residency) preferredPossess advanced knowledge and clinical training in a medical / scientific area (Rheumatology) required5 years of experience in clinical research or drug development from the pharmaceutical / biotechnology industry, preferably spanning clinical activities in phases I through IV3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global / matrixed environmentShowcase advanced knowledge of assigned therapeutic areaDemonstrate ability to establish strong scientific partnership with key partnersNeed thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory / clinical development processesPeople management experience preferred, especially at the global level (this may include management in a matrixed environment)EEO Statement : The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility and reasonable accommodationsThe 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$257,600.00 - $386,400.00 Skills DesiredBudget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring 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.#J-18808-Ljbffr

Salary : $257,600 - $386,400