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Associate Clinical Development Medical Director

Novartis

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Cambridge, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

10 major new medicines planned for launch over the next few years creating new career opportunities for those who want to make a direct impact on patients at scale improving people’s lives. Novartis Oncology has a renowned history in hematology and oncology of developing transformative therapies for patients.

As the Associate Clinical Development Medical Director, you will be the clinical leader of defined program level activities such as submission activities, briefing books or sophisticated trials, under the leadership of the Global Program Clinical Head. You may lead a section of a clinical program, an indication, new formulation, or specific development phase. In Clinical Development Hematology, 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.

What you’ll be doing:
Your responsibilities include, but are not limited to:
• Provide clinical leadership and medical strategic input for all clinical results in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program standards, clinical components of regulatory documents/registration dossiers, and publications
• Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Drive execution of the section of the clinical program in partnership with line functions, assigned Global Trial Director, and regional/country medical associates
• Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert
• May be the Program Manager of other associates Support GPCH in ensuring safety of the molecule for the assigned section, may be a core member of the Safety Management Team, and support overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports and other safety related documents) in collaboration with Patient Safety
• Work with the Clinical Development Head providing medical input into the Development Plan and Clinical Trial Protocol reviews and driving development of disease clinical standards for new disease areas.
• Support the GPCH or CDH in interactions with external partners (authorities, opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcome Research), and decision boards
• Work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with Business Development & Licensing


Minimum requirements

What you’ll bring to the role:
• MD or equivalent medical degree required. Extensive knowledge and clinical training in a medical/scientific area required, with Medical Board Certification preferred.
• 3+ years of direct involvement in clinical research or drug development in an academic or industry environment or equivalent, spanning clinical activities preferably in Phases I through IV. Having contributed to and accomplished in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry or equivalent
• Minimum 5 years of clinical experience in hematology/oncology
• Experience in Clinical Trials

Desired:
• Detailed knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
• People management experience preferred; this may include management in a matrix environment. People management experience desirable
• Excellent negotiation, conflict resolution and communication skills (written and oral).

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. 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!

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]

EEO Statement

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 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.