BioSpace
Director, Preclinical Project Development and Strategic Lead
BioSpace, Trenton, New Jersey, United States
Director, Preclinical Project Development and Strategic Lead
2 days ago – Be among the first 25 applicants
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths of both companies to advance an immunotherapy for multiple myeloma.
Role Overview The Preclinical Development and Strategic Lead is responsible for planning, executing, and overseeing preclinical development projects at Legend. The incumbent will manage cross‑functional teams, ensure adherence to IND submission timelines, budgets, and regulatory requirements, and act as the central point of communication between stakeholders to advance Legend’s drug development efforts.
Key Responsibilities
Preclinical IND enabling study oversight
Work closely with program teams to develop preclinical IND strategies and ensure high‑quality delivery of IND studies.
Develop and manage project plans, timelines, budgets, and resources for preclinical IND programs.
Coordinate and monitor preclinical studies, including in‑vitro and in‑vivo work, and align them with program goals.
Track project progress, identify risks, and implement mitigation strategies to maintain timelines and deliverables.
Cross‑functional collaboration
Serve as a liaison between internal departments (research, toxicology, pharmacology, CMC, regulatory affairs) and external partners such as CROs.
Facilitate communication and collaboration among multidisciplinary teams to achieve project milestones.
Ensure preclinical studies comply with relevant regulatory guidelines (e.g., GLP, FDA, EMA).
Prepare or support the creation of regulatory submissions, including pre‑IND packages and investigator brochures.
Data Management and Reporting
Oversee data collection, analysis, and documentation for preclinical studies.
Prepare project reports, presentations, and summaries for internal and external stakeholders.
Vendor and Budget Management
Identify, evaluate, and manage relationships with contract research organizations (CROs) and other external vendors.
Negotiate contracts, oversee budgets, and ensure high‑quality deliverables from external partners.
Strategic Input
Contribute to the design and development of preclinical study strategies to support clinical translation.
Provide input on program development based on emerging data and scientific trends.
Requirements
PhD in biology, biochemistry, or a related field.
At least 10 years of relevant work experience, including a minimum of 5–8 years in preclinical research and development within the pharmaceutical or biotech industry.
Experience with IND submission of cell or biotherapeutics.
Familiarity with preclinical drug development processes, regulatory guidelines, and GLP standards.
Strong organizational and project‑management skills, with the ability to manage multiple projects simultaneously.
Excellent communication and interpersonal skills for cross‑functional collaboration and stakeholder engagement.
Knowledge of regulatory requirements and preclinical study design principles.
Experience working with CROs and managing external collaborations.
Certification in project management (e.g., PMP, PRINCE2) is a plus.
The anticipated base pay range is $187,989 – $246,737 USD.
Benefits Legend Biotech provides a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy that includes 15 vacation days, five personal days, five sick days, eleven U.S. national holidays, and three floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Legend’s policy ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy), sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship status, uniformed service member, veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
#J-18808-Ljbffr
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths of both companies to advance an immunotherapy for multiple myeloma.
Role Overview The Preclinical Development and Strategic Lead is responsible for planning, executing, and overseeing preclinical development projects at Legend. The incumbent will manage cross‑functional teams, ensure adherence to IND submission timelines, budgets, and regulatory requirements, and act as the central point of communication between stakeholders to advance Legend’s drug development efforts.
Key Responsibilities
Preclinical IND enabling study oversight
Work closely with program teams to develop preclinical IND strategies and ensure high‑quality delivery of IND studies.
Develop and manage project plans, timelines, budgets, and resources for preclinical IND programs.
Coordinate and monitor preclinical studies, including in‑vitro and in‑vivo work, and align them with program goals.
Track project progress, identify risks, and implement mitigation strategies to maintain timelines and deliverables.
Cross‑functional collaboration
Serve as a liaison between internal departments (research, toxicology, pharmacology, CMC, regulatory affairs) and external partners such as CROs.
Facilitate communication and collaboration among multidisciplinary teams to achieve project milestones.
Ensure preclinical studies comply with relevant regulatory guidelines (e.g., GLP, FDA, EMA).
Prepare or support the creation of regulatory submissions, including pre‑IND packages and investigator brochures.
Data Management and Reporting
Oversee data collection, analysis, and documentation for preclinical studies.
Prepare project reports, presentations, and summaries for internal and external stakeholders.
Vendor and Budget Management
Identify, evaluate, and manage relationships with contract research organizations (CROs) and other external vendors.
Negotiate contracts, oversee budgets, and ensure high‑quality deliverables from external partners.
Strategic Input
Contribute to the design and development of preclinical study strategies to support clinical translation.
Provide input on program development based on emerging data and scientific trends.
Requirements
PhD in biology, biochemistry, or a related field.
At least 10 years of relevant work experience, including a minimum of 5–8 years in preclinical research and development within the pharmaceutical or biotech industry.
Experience with IND submission of cell or biotherapeutics.
Familiarity with preclinical drug development processes, regulatory guidelines, and GLP standards.
Strong organizational and project‑management skills, with the ability to manage multiple projects simultaneously.
Excellent communication and interpersonal skills for cross‑functional collaboration and stakeholder engagement.
Knowledge of regulatory requirements and preclinical study design principles.
Experience working with CROs and managing external collaborations.
Certification in project management (e.g., PMP, PRINCE2) is a plus.
The anticipated base pay range is $187,989 – $246,737 USD.
Benefits Legend Biotech provides a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy that includes 15 vacation days, five personal days, five sick days, eleven U.S. national holidays, and three floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Legend’s policy ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy), sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship status, uniformed service member, veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
#J-18808-Ljbffr