Job Description
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Director, Portfolio Development Process & Standards Lead? This position is located in our King of Prussia, PA Waltham MA or Maidenhead UK office. It is a hybrid role three days onsite. You will report to the Head, Porfolio Development Excellence, Process & Compliance.
You will be responsible for establishing and maintaining a framework that allows the Global Portfolio Development group, in collaboration with multiple partner functions across the organization, to plan, evaluate and report clinical trials and programs under highest quality standards
REQUIREMENTS:
Portfolio Development Excellence: Procedures, training, continued learning, and guidance
Manages all Portfolio Development (CD/BM/CO) owned SOP updates in collaboration with critical partner SMEs where appropriate and ensures they are updated to reflect current processes and structure
Drives the development of a fit for purpose technical training curriculum across PD that supports achieving quality program goals and standards.
Provides guidance on process/procedural expectations and stakeholder management.
Driving excellence through change management and objectives oversight in partnership with PD Chief of Staff
Tracks and manages all Portfolio Development sponsored process development / improvement initiatives, in collaboration with the appropriate delegates and surface to PD CoS Identifies and drives cross functional initiatives to bring in technology
May sponsor or lead cross-functional initiatives supporting design and execution excellence
Tracks and manages all procedural documents update requirements to ensure compliance across the department in collaboration with the Portfolio Development Leadership Team and appropriate delegates.
Provides innovative solutions to increase the excellence of Portfolio Development; aiming to reduce complexity, increase quality and speed, and reduce decision making churn.
Represents Portfolio Development for applicable cross-functional R&D initiatives and forums.
Core reviewer on all Portfolio Development SOP updates to ensure changes work systematically across procedural documents.
QUALIFICATIONS:
Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
12+ years experience in the biotechnology or pharmaceutical industry (or biomedical research organization)
In-depth knowledge of drug development and GCP environment
5+ years experience in managing projects in Clinical Research and Development, first-hand experience in the execution of clinical trials is required
3+ years experience in managing process improvement initiatives, and influencing change in an organization.
Proven experience in leading cross-functional, multicultural and international (product development) teams
The expected base salary range for this position at hiring is $250,000 - $280,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham MA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Director, Portfolio Development Process & Standards Lead? This position is located in our King of Prussia, PA Waltham MA or Maidenhead UK office. It is a hybrid role three days onsite. You will report to the Head, Porfolio Development Excellence, Process & Compliance.
You will be responsible for establishing and maintaining a framework that allows the Global Portfolio Development group, in collaboration with multiple partner functions across the organization, to plan, evaluate and report clinical trials and programs under highest quality standards
REQUIREMENTS:
Portfolio Development Excellence: Procedures, training, continued learning, and guidance
Manages all Portfolio Development (CD/BM/CO) owned SOP updates in collaboration with critical partner SMEs where appropriate and ensures they are updated to reflect current processes and structure
Drives the development of a fit for purpose technical training curriculum across PD that supports achieving quality program goals and standards.
Provides guidance on process/procedural expectations and stakeholder management.
Driving excellence through change management and objectives oversight in partnership with PD Chief of Staff
Tracks and manages all Portfolio Development sponsored process development / improvement initiatives, in collaboration with the appropriate delegates and surface to PD CoS Identifies and drives cross functional initiatives to bring in technology
May sponsor or lead cross-functional initiatives supporting design and execution excellence
Tracks and manages all procedural documents update requirements to ensure compliance across the department in collaboration with the Portfolio Development Leadership Team and appropriate delegates.
Provides innovative solutions to increase the excellence of Portfolio Development; aiming to reduce complexity, increase quality and speed, and reduce decision making churn.
Represents Portfolio Development for applicable cross-functional R&D initiatives and forums.
Core reviewer on all Portfolio Development SOP updates to ensure changes work systematically across procedural documents.
QUALIFICATIONS:
Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
12+ years experience in the biotechnology or pharmaceutical industry (or biomedical research organization)
In-depth knowledge of drug development and GCP environment
5+ years experience in managing projects in Clinical Research and Development, first-hand experience in the execution of clinical trials is required
3+ years experience in managing process improvement initiatives, and influencing change in an organization.
Proven experience in leading cross-functional, multicultural and international (product development) teams
The expected base salary range for this position at hiring is $250,000 - $280,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham MA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
About CSL
For over a century, we’ve been an unstoppable force, from developing medicines that save and improve lives to vaccines that protect them. Today, with the combined expertise of CSL Behring (with oversight to CSL Plasma), CSL Seqirus, and CSL Vifor—and our singular commitment to relentlessly innovate—CSL’s offerings are more diverse than ever to help ensure patients and people everywhere get the treatments they deserve. We’re always improving so life can, too.
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