- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
- Lead development of clinical sections of trial and program level regulatory documents
- Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates
- Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues
- Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan and Clinical Trial Protocol reviews. and contributing to development of disease clinical standards for new disease areas
- As a medical specialist, supporting the GPCH or CDH in interactions with external and internal partners and decision boards
- May work with the Novartis Institute of Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical matters, as needed.
- Novartis: e-mail [email protected] or call
- Sandoz: e-mail [email protected] or call:
- MD or equivalent medical degree is required, in addition to extensive knowledge and clinical training in medical/scientific areas, RLT.
- 3+ years minimum in clinical research or drug development.
- Working knowledge of Hematology/Oncology with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trials.
- Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
- Demonstrated ability to establish effective scientific partnerships with key partners.
- Clinical practice experience 4+years (including residency) preferred.
- Previous global people management experience is preferred, though this may include management in a matrix environment.
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Clinical Development Medical Director - East Hanover, United States - Novartis AG
Description
About the RoleOver 108,000. That's how many US patients our oncology products touched in 2018.
Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers and serious or life-threatening blood disorders.
We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.
As the Clinical Development Medical Director (CDMD) in RLT, you will lead the planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective and drive execution of the plan, enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
In Clinical Development Oncology, our aim is to design innovative, patient friendly clinical development plans to rapidly bring outstanding treatments to patients, caregivers and healthcare systems.
We are striving to develop treatments for Lung, Breast & Prostate Cancers, MDS & AML, CML and sickle-cell disease, and are pushing the boundaries of innovation with CAR-T and Radioligand therapies.
Your key responsibilities:
The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity).
If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense.
The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment.
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
What you'll bring to the role:
Desirable:
You'll receive:
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Why Novartis?
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.
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 tryingImagine what you could do here at Novartis
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
