Clinical Development Medical Director Immunology 80-100%**
East Hanover, NJ
Job Description10! That’s how many pipeline projects Immunology has in Phase 3 or registration and over 25 projects in Phase 1/2. Our Immunology Unit has a pipeline with depth and breadth and is known to be a talent powerhouse. We are uniquely positioned to have a critical impact on bringing innovative medicines to patients across multiple disease areas.
As a Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.
The 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).
Your responsibilities include, but are not limited to:
• 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 associates
• Oversee/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 monitor
• Support 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 Safety
• Support 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 areas
• Provide 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 NIBR (Novartis Institute of Biomedical Research)/Translational Medicine) to drive transition of early development projects to Transition Decision Point and with Business Development, including target identification and due diligences
• Ensure career development of Program Reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support
Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for Global Clinical team
May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
Minimum requirementsMinimal Requirements:
• MD (or equivalent medical degree) required. Training in Immunology/Rheumatology/Dermatology preferred
• Medical Board certification preferred. 4+ years Clinical practice experience (including residency) preferred
• Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required
• 5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
• 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrixed environment
• Showcase advanced knowledge of assigned therapeutic area
• Demonstrate ability to establish strong scientific partnership with key partners
• Need thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes
• People management experience preferred, especially at the global level (this may include management in a matrixed environment)
• Exhibit excellent business communication and presentation skills
• Possess strong interpersonal skills
• Adept with excellent negotiation and conflict resolution skills
**Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.
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769 million lives were touched by Novartis medicines in 2020, 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.
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!
The pay range for this position at commencement of employment is expected to be between $257,600-386,400 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.