Director, Patient Focus Practice Lead, Clinical Research

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Mar 31, 2021
Ref
R-131638
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Director, R&D Patient Partnerships, Clinical Research is responsible for supporting the continued development and implementation of strategies to incorporate the patient/caregiver and health care provider voice & insights into the drug development process. This role is responsible for supporting the development and expansion of strategic and operational capabilities across CSL Behring's therapeutic areas and global locations.

This position is expected to support the identification, creation, and deployment of transformative solutions to clinical trial challenges by putting patients/caregiver interests first. This is achieved through engaging and listening to the needs and experience of key contributors including patients, caregivers, investigators, site staff and patient organizations. The Director will support the synthetization of the complex, multidimensional inputs into transformative solutions. All of this is to be done with the goal of meeting CSL's strategic development plans and business means with an approach that results in more patient-friendly, site-friendly, and efficiently executed trials to bring innovative therapeutics to patients.

The Director will responsible for supporting the development of internal capabilities to embed patient-focused strategies into the trial execution operating model; helping to pilot new ways to consult or co-create with patients; support the establishment of metrics or methods to value these activities; and to be a passionate champion for the patient-focused culture.

This position will work in collaboration with the Clinical Development Operations Leadership Team and will be responsible for supporting all Therapeutic Areas and Geographic Regions in the delivery of clinical trials.

Reporting Relationships:
  • Reports to: Head, R&D Patient Partnerships
  • Matrix Environment: Collaborates with Clinical Development Operations leaders; Clinical Research, Medical Writing, Medical Affairs, Commercial, Regulatory, and Clinical Quality Assurance. Partners with Senior Director, R&D Patient Partnerships to drive synergy across CSLB.
  • Direct reports: Future positions as the role and capabilities grow


Main Responsibilities and Accountabilities:

Build, maintain, & evolve capabilities, approaches, standards, and relationship networks (internal & external) to incorporate the patient and site voice and Establish/maintain CSL Behring's reputation as "Sponsor of Choice"
  • Support efforts to develop strong relationships with patient organizations, advocacy groups and/or clinical trial participant patient advocates on a global scale
  • Collaborates with CDO in 1) Obtaining and understanding patient/caregiver needs and experience to obtain insights to optimize protocol development & operational design; 2) developing and implementing patient recruitment & retention strategies, including communication & informational tools and study compliance methodologies
  • Leads efforts to establish a network with appropriate patient and site groups and continuously monitor the external landscape that aligns with CSL's therapeutic and disease areas; develop new, and deepen existing, patient advocacy relationships within rare disease space globally
  • Lead or partner on clinical trial awareness and patient identification initiatives across the portfolio of development programs
  • Build and oversee relationships with relevant external service providers that align with CSLB's values and objectives to deliver on the patient-focused strategies
  • Responsible for the management of any relevant systems and budgets for clinical research-related patient engagement activities, ensuring clear return on investment and utilization is provided.
  • Initiates efforts to raise awareness and advocate for patient-centricity in clinical research with internal and external stakeholders. Develop business case and manage key performance indicators for Patient Engagement tactics and initiatives to ensure stronger performance, shorter cycle time, higher quality and optimal resource utilization.
  • Oversee interface with study teams to facilitate knowledge and use of Patient Engagement tools, processes and strategies to improve study delivery and enhance CSLB reputation and relationships.
  • Upholds and promotes the Company's reputation externally by demonstrating high professional standards and integrity in all external contacts.
  • Maintains up to date knowledge of the Clinical Operations landscape, industry best practices and regulatory considerations.
  • Partners with R&D Patient Partnerships team and relevant Functional leads to develop and maintain a Patient Focus Framework for the organization
  • Manages or supports assigned enterprise-wide connected network for Patient Focus
  • Contributes to or enables relevant elements of a coordinated communication strategy for Patient Focus
  • Participates in or presents at relevant industry events and identifies practices or approaches to incorporate into CSL's approach to patient-focused clinical trials


Position Qualifications and Experience Requirements

Education

A minimum undergraduate degree in life science 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).

Experience

Essential Experience
  • A combination of a minimum of 10+ years' relevant clinical research (or related) experience within the pharmaceutical industry, and direct experience interacting with and/or representing patients and their caregivers
  • Experience with patient journey or experience mapping
  • Experience with working with patient advocacy groups, focus groups or related approaches to obtaining insights from patients and their caregivers
  • Experience in implementation of patient engagement methodologies
  • Recognized thought leader in patient engagement, experienced in developing process and standards that support an overarching strategy for patient-focused clinical trials
  • Experienced with senior management interactions, presentations, and stakeholder managements
  • Requires ability to act as a change-agent; influence others to accept new practices and approaches, and to influence executive leadership on matters of strategic importance
  • A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
  • Solid understanding of privacy and compliance of interactions with patients, their support network and HCPs
  • Budget forecasting and management.
  • Thorough knowledge of ICH GCP and its applicability to all stages of the clinical development process.

Desired Attributes The following are considered desirable:
  • Postgraduate qualifications.
  • Experience in development and implementation of global patient engagement strategy and methodologies in clinical development
  • Able to evaluate information qualitatively and quantitatively

Skills
  • Empathic and passionate individual with the ability to build meaningful experiences with patients/caregivers, understanding the impact of living with a specific disease
  • Demonstrated ability to learn and capacity to make decisions / recommendations despite a large degree of ambiguity and experience in coaching peers and colleagues
  • Demonstrated ability to set priorities and manage cross-functional teams and complex projects to deliver milestones
  • Experience driving organizational and cultural change
  • Excellent verbal and written communication skills; strong inter-personal skills with demonstrated ability to work effectively across the matrix
  • Flexibility to work within a fast-changing environment and cope with degrees of ambiguity
  • Strong advisory and influencing skills including senior leadership
  • Global focus and cross-cultural awareness

Working Relationships:
  • Internal contacts include VPs, Sr. directors, directors, managers, study team members and research related departments (e.g. clinical services, therapeutic areas). Other internal contacts may include manufacturing, project management, Clinical Safety, Clinical Quality Assurance, Business Development, Commercial Development, and Commercial Operations.
  • External contacts include MD investigators, clinical staff, contract research organizations, patient advocacy groups, and outside consultants.


Travel requirements: Domestic and international travel required as needed.