Project Team Member, Preclinical Safety - Cambridge, United States - Novartis Group.
Description
339639BR
**Project Team Member, Preclinical Safety**
Job Description
scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to needy patients, then look no further, NIBR is the place to be.
As a Project Team Member (PTM), you will represent the Preclinical Safety (PCS) group to collaborate, align and influence on cross-functional project teams, with the goal to identify and mitigate project issues related to preclinical safety and assuring the appropriate design and execution of nonclinical safety assessment plans for projects.
Your responsibilities will include:
Represent PCS on Novartis Institutes for BioMedical Research (NIBR) and Global Drug Development (GDD) project teams in the Respiratory and Global Health portfolios to provide expert nonclinical safety input to key milestone presentations / documents in a timely manner. Identify potential project hurdles, provide solutions and establish contingency plans as necessary.
Works directly with project teams to design and interpret nonclinical safety aspects of drug development, including decision analysis, regulatory acceptability and issue resolution while maintaining alignment with the PCS TA strategy team.
Lead the development of detailed, integrated, scientifically relevant and compliant nonclinical safety assessment plans to support development / registration / renewal of drugs of various modalities.
Timely communication to PCS Therapeutic Area Head, target team and project team regarding theoretical or observed safety effects; their impact and proposed plans to address them; resource requirements to execute nonclinical safety plan.
Prepares scientific documentation relating to nonclinical safety aspects in collaboration with project team members for regulatory and internal documents such as Investigator Brochures, IND/CTAs, NDA/MAA/BLAs, Marketing Authorization renewals, Health Authority briefing books and others. Is proficient in knowing / applying respective FDA, ICH and OECD guidelines.
Responsible for non-clinical safety deliverables to PSURs, DSURs, annual reports, product renewals, Core Data Sheets and label updates including PLLR alignment for USPI of marketed products.
Clear, concise and accurate communication of nonclinical safety results and their impact to Health Authorities and investigators. Prepare appropriate responses to all Health Authority questions for both development and/or marketed products.
Conducts literature searches and analyzes relevant safety data, updates safety assessment when relevant
Prepare cytotoxicity assessment memorandums of drug substances to guide drug production aspects as well as hazardous drug substance assessment based on NIOSH criteria towards USP800.
Evaluate in-licensing opportunities, carry out Due Diligence activities, and coach other PCS associates in Due Diligence activities.
Participates in Translational Medicine or Preclinical Safety sub-teams and initiatives to drive efficiency and optimization, may also participate in external scientific organizations.
Maintains scientific and regulatory expertise in the fields of drug development and safety assessment.
Adhere in strict accord to the appropriate SOP, GLP and other guidelines.
Position can be located in Basel, Switzerland or USA (Cambridge, MA or East Hanover, NJ)
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.*
Minimum requirements
Minimum requirements :
What youll bring to the role:
PhD in a biological or chemical science (e.g. pharmacology, toxicology, immunology, biochemistry) or MD / DVM / PharmD/M.S. with appropriate training and work experience
Business-level English, oral and written
Minimum 5 years in relevant preclinical safety function in industry or regulatory agency
Demonstrated experience in preclinical safety issue resolution, successful communication and negotiation with global Health Authorities
Demonstrated understanding of regulatory submission components for registration (CTD) including mastery in authoring submission components in Documentum-like system
IND/CTA submission experience; BLA/NDA/MAA submission experience highly desirable
Knowledge of regulatory requirements
Demonstrated success leading and influencing in matrix team settings is highly desirable
Proven record as a team member/leader with excellent negotiation skills
Excellent organizational and project skills
769 million lives were touched by Novartis medicines in 2020, and while we are proud of this, we know there is so much more we could do to help improve and extend peoples 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 is possible, when we collaborate with courage to aggressively and ambitiously tackle the worlds toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do at Novartis
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
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:
Division
NIBR
Business Unit
Translational Medicine
Country
USA
Work Location
Cambridge, MA
Company/Legal Entity
NIBRI
Alternative Country 1
Switzerland
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
** Project Team Member, Preclinical Safety | Novartis**