Director, Portfolio Development Process & Standards Lead

CSL Plasma Inc.; Waltham, Northern (MA, KY); Hybrid; USD 230,000 - 270,000; Full time

Job summary

CSL Behring is seeking a senior leader to establish and maintain a framework for planning, evaluating, and reporting clinical trials and programs with high quality standards.

The role oversees SOP updates, develops a fit-for-purpose training curriculum, and guides stakeholders across PD to streamline processes and reduce decision churn.

Qualifications

• Bachelor’s degree or equivalent in life sciences or related health field.
• Extensive experience in biotechnology/pharma; 12+ years preferred.
• Experience in managing clinical development projects and process improvements.

Responsibilities

• Establish and maintain a framework to plan, evaluate and report trials and programs.
• Lead cross-functional teams and drive change management across PD.
• Develop training curricula and ensure SOP updates reflect current processes.
• Surface to PD CoS and drive cross-functional initiatives for efficiency.

Education

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

12+ years experience in the biotechnology or pharmaceutical industry

Tools

GCP knowledge

Job description

REQUIREMENTS

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. 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 $230,000- $270,000. 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.

Benefits

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

About CSL Behring

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 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 click here.

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