Global Clinical Development Manager

316318BR
Apr 06, 2021
USA

Job Description

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
Job Purpose
Supports the timely, high quality initiation of CRO collaboration and successful completion of the assigned clinical development program(s). Provides medical support to the design, execution and reporting of assigned clinical trials and is responsible for the medical oversight on CROs' performance. Drives alignment of non-clinical development with clinical development. Must be willing and capable to deputize for GPMD at GPT.
Supports the GPMD/sGPMD in strategic biosimilar development from a clinical perspective, starting with candidate selection, in depth analyses on risks, value and strategic fit of assets within portfolio management, followed by consecutive stages of program maturation, in collaboration with CRO and respective internal subject areas throughout clinical development, submission and life cycle management. May deputize for the GPMD/sGPMD in corresponding activities.
Major Accountabilities
• Contributes to the regulatory strategy of the clinical development program and can be assigned as co-author of the Clinical Development Plan.
• Contributes to the design, conduct, monitoring and reporting of clinical trials in close collaboration with the CRO.
• Provides clinical research expertise and medical expertise as needed.
• Leads all aspects of generation of clinical trial protocols (PhI and PhIII/ adaptive trials) by CRO and warrants compliance with strategic study concept sheet/synopsis, clinical practices, state of the art development methodologies and regulations in order to produce scientifically sound and conclusive results.
• Involved in monitoring clinical trial conduct by CRO to assure timely completion of all trials
• Can be assigned as chair/co-chair to lead joint clinical team if required
• Supports CRO medical lead/ internal GPMD and safety lead/ pharmacovigilance lead in signal detection*
• Leads all aspects of CRO input in safety and provides support as needed to annual pharmacovigilance reports to (e.g. DSUR, PSUR, RMP)*

Diversity & Inclusion / EEO

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.

Minimum Requirements

Experience:
• MD, specialization as appropriate for project therapeutic area is desirable, or PhD with sufficient development experience.
• At least 5 years of experience in industry. (preferred)
• Experience in conducting Phase I and global Phase III efficacy and safety trials. Experience in Ph I bioequivalence trials appreciated.
• At least 3 years of experience as GCDM (or corresponding function) ideally including contribution to two clinical development programs resulting in regulatory filing. (preferred)
• Extensive experience in CRO interface management and sponsor oversight at a global level, especially in the setting of fully outsourced clinical trials.
• Knowledge of adaptive clinical trial design. Solid understanding in areas such as statistics and pharmacology (pharmacokinetics). Proficiency in authoring of clinical trial protocols.
• Proven ability to interpret, discuss and present efficacy and safety data

Why consider Sandoz?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
SANDOZ
BioPharma SZ
USA
Princeton, NJ
Research & Development
Full Time
Regular
No
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316318BR

Global Clinical Development Manager

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