54,257 Project Leadership jobs in the United States

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing 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. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an Executive Director, Pipeline Project Leadership as part of the Research & Development team based in Somerset, NJ.

Role Overview

The Executive Director, Pipeline Project Leadership at Legend Biotech will create and lead project development teams for cell therapies and related modalities in a robust pipeline aimed at changing the course of medicine. He/she will be responsible for leading the strategic direction of the cross-functional product teams, guiding them from development to commercial launch. This role involves setting development and strategic goals, integrating key functions such as non-Clinical, Clinical, Regulatory, CMC, and Commercial into comprehensive plans, and ensuring timely and effective delivery. The position demands strong leadership in product development and team management, particularly in cell therapy and related modalities, within a collaborative, science-based, and patient-focused environment. The Project Leader will be the point of accountability for delivering pipeline projects.

Key Responsibilities

• Establish and lead cross-functional project teams for each endorsed project
• Lead cross-functional teams in harnessing the strengths of functional area leaders, establish a cohesive integrated development strategy, set clear team goals, and foster a collaborative team dynamic
• Implement effective project leadership and project management methodologies to ensure the timely and successful delivery of results.
• Identify relevant cross functional dependencies and constraints and work to facilitate timely resolution to achieve the desired outcomes.
• Enable effective and rapid decision making with clear risks, mitigations, go/no-go criteria as part of a holistic operational plan to achieve success
• Operates with strong financials, company priorities and needs of partners
• Lead teams in preparation and execution of comprehensive development plans (e.g product, clinical, regulatory, commercial) and associated documents for each development program ensuring the requirements for all relevant areas are achieved
• Mentor and develop future talent from technical functions and create a pipeline for project leaders for early-stage programs
• In collaboration with the project manager, lead the creation and adjustment of aggressive timeline strategies with clear communication of underlying assumptions
• In collaboration with the project manager, proactively monitor project goals and provide timely communication on progress across all relevant levels of the organization including senior leadership
• Function as a single point of accountability for each project, including those with junior project leaders mentored by the successful candidate
• Adjust project strategies to changing company priorities and portfolio evolution
• In collaboration with the project manager, ensure high quality project execution
• Direct the advancement of each project through governance endorsement at each stage-gate review
• In collaboration with the project manager, ensure a robust risk register and execution of mitigation strategies
• Maintain strong awareness of competitive landscape and adapt project approaches to maintain best/first in class
• Collaborate with the project management office to evolve company processes for product development
• Establish a collaborative, science-based, agile, innovative, continuous improvement, and patient-focused culture for each project team
• Contribute to portfolio vision and prioritization
• Function as a single point of accountability for each project, including those with junior project leaders mentored by the successful candidate
• Build strong collaborative relationships with functional areas and creates a culture of transparency, unity and engagement
• Resolve conflict and proactively identify performance issues detrimental to the team and organization

• Advanced degree (MD, PhD, PharmD) or equivalent with 15 years of industry experience and demonstrated leadership in a project management and/or supervisory role
• 15+ years of industry experience in a biotech or pharmaceutical setting
• Excellent leadership, emotional intelligence, and communication skills
• Experience with development of autologous or allogeneic cell therapies and viral vectors, and the overall pharmaceutical development process and road maps
• Experience in therapeutic areas such as hematological malignancies, autoimmune diseases, and solid tumors
• Strong grasp of science with analytical skills to drive data-based decision making
• Demonstrated proficiency in drug development with sufficient awareness of CMC challenges for cell therapies and viral vectors
• Robust understanding of regulatory consideration of product development
• Proven track record of leading cross-functional teams, solving complex problems, prioritization, and building teams
• Creative, strategic thinking
• Composure during challenging times
• Strong troubleshooting skills
• Language: English. Mandarin is a plus.

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.

Parexel currently has Home Based Project Leadership opportunities at levels to fit your experience and career goals.
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You will oversee all elements of the trial to ensure project deliverables and client satisfaction are executed to the highest standards. You will actively lead cross functional Parexel and client teams by combining deep clinical research experience with insight into client pressures to develop the right solutions for the clients. Your experience running global clinical trials across all phases will help you achieve operational excellence through on time and on budget delivery to the highest quality. As member of the Project Leadership team, your goal is to exceed client expectations, and help your team achieve success by serving as a role model and coach.

The Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client's needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas.

Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum, 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Drug Metabolism and Pharmacokinetics (DMPK) team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts! Responsibilities: • Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions. • Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical PK/PD, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize ADME properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages. • Lead R&D initiatives to grow and develop ADME/DMPK capabilities for across experimental and drug modalities including biologics/antibodies. • Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies. • Prepare data packages and develop content in regulatory documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent ADME in face-to-face discussions with regulators. • Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic ADME principles. • Effectively partner to apply innovative PBPK approaches to translate and predict human PK, inform clinical plans and support registration. • Communicate the value of mechanistic ADME approaches both internally within R&D and externally including regulatory agencies. • Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area. Basic Qualifications: Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology. Additional Skills/ Preferences: • Experience in drug discovery and development across a variety of therapeutic areas. • Experience with biologics/antibodies. • Detailed understanding of pharmacokinetics, ADME, drug interactions and proficiency to communicate theory and concepts clearly. • Ability to balance multiple projects and handle competing responsibilities. • Experience with modeling software (e.g. SimCYP, GastroPlus, NONMEM, Matlab, etc.). • Demonstrate strong communication skills with the ability to integrate diverse perspectives, adroitly deliver critical messaging, and influence leaders/key partners. • Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $294,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. Were looking for people who are determined to make life better for people around the world.

Lillys Drug Metabolism and Pharmacokinetics (DMPK) team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts!

Responsibilities:
Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions.
Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical PK/PD, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize ADME properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages.
Lead R&D initiatives to grow and develop ADME/DMPK capabilities for across experimental and drug modalities including biologics/antibodies.

Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies.
Prepare data packages and develop content in regulatory documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent ADME in face-to-face discussions with regulators.
Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic ADME principles.
Effectively partner to apply innovative PBPK approaches to translate and predict human PK, inform clinical plans and support registration.
Communicate the value of mechanistic ADME approaches both internally within R&D and externally including regulatory agencies.
Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area.

Basic Qualifications:
Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology.

Additional Skills/ Preferences:
Experience in drug discovery and development across a variety of therapeutic areas.
Experience with biologics/antibodies.
Detailed understanding of pharmacokinetics, ADME, drug interactions and proficiency to communicate theory and concepts clearly.
Ability to balance multiple projects and handle competing responsibilities.
Experience with modeling software (e.g. SimCYP, GastroPlus, NONMEM, Matlab, etc.).
Demonstrate strong communication skills with the ability to integrate diverse perspectives, adroitly deliver critical messaging, and influence leaders/key partners.
Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.

Parexel currently has Home Based Project Leadership opportunities at levels to fit your experience and career goals.
.
You will oversee all elements of the trial to ensure project deliverables and client satisfaction are executed to the highest standards. You will actively lead cross functional Parexel and client teams by combining deep clinical research experience with insight into client pressures to develop the right solutions for the clients. Your experience running global clinical trials across all phases will help you achieve operational excellence through on time and on budget delivery to the highest quality. As member of the Project Leadership team, your goal is to exceed client expectations, and help your team achieve success by serving as a role model and coach.

The Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client's needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas.

Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum, 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.

Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics including Oncology, Rare Disease, Gene- Cell Therapy. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients.

Parexel currently has Home Based Biotech Project Leadership opportunities at all levels to fit your experience and career goals.

Individuals selected for these roles will provide leadership to project teams and manage the day to day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations

Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director and Project Director.

To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.