Director, Clinical Trial Patient Advocacy - United States
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Primary purpose and function of this position:
Develop and implement vision to partner with disease-based and minority focused advocacy groups to bring voice of patient into clinical drug development, bring awareness and accessibility to Celgene clinical trials portfolio and diversify clinical trial sites and study participants. Responsible to partner with Corporate Advocacy group, affiliates, clinical development teams to bring patient and caregiver insights into clinical development plan and support development of patient engagement and recruitment plans for critical Celgene programs.
Major duties and responsibilities:
- Develop and maintain strong relationships with key disease-based and minority-focused advocacy organizations, and leverages these relationships to remain informed and achieve goals related to the ongoing support of compounds in clinical development, specifically around clinical trial recruitment.
- Collaborates with advocacy groups around key issues related to clinical trials, drug development, and patient awareness.
- Develops strategies and tactics to engage patients, caregivers and advocacy groups in the development of protocol design and study operationalization.
- Proactively brings the “Voice of the Patient” to the Clinical Teams to ensure that barriers that may prevent study enrollment are discussed, and to ensure that solutions are identified.
- Development, management and execution of voice of patient plans/playbook at disease and/or compound level to support well integrated site and patient centric patient recruitment program
- Partner with Corporate advocacy group to build and enhance relationships with advocacy , community and diversity groups to raise awareness of Celgene clinical trial portfolio
- Ensures that the data generated by Clinical Trial Planning and Analytics (CTPA) group & feasibility activities is adequately interpreted and leveraged in serving as foundation for identifying patient advocacy opportunities
- Works closely with the Clinical development, Lead AD/D, Trial managers, MSLs, commercial, e-business etc. for understanding and development of patient journey that will support patient recruitment plan and to ensure smooth flow of information and coordination of activities to optimize site and patients engagement for clinical trials.
- Conducting and leveraging lessons learned emerging from use of innovative patient recruitment, retention and engagement strategies to formulate recommendations for optimal use of these emerging principles.
- Fosters a collaborative, innovative, problem-solving culture and mindset
- Provides training in patient advocacy and clinical research engagement for team members (as applicable).
- Provide regular communication and updates to all relevant stakeholders.
- Support scientific / educational local meetings for site personnel (as applicable).
- Establishes and fosters relationships and professional contact with investigators, advocacy groups, consultants and vendors as needed.
- Study stakeholder management KOLs, Patient Groups on a needs basis.
- Ensures that all activities meet regulatory requirements and are conducted to GCP standards.
- Effectively participates in project teams and company-wide committees.
- Acquires knowledge related to drug development program, clinical trials methodology and clinical operations as needed.
Education and Knowledge Requirements:
- BA/BS degree or equivalent.
- More than 7 years in patient advocacy and/or a combination of patient advocacy and clinical drug development in the bio-pharmaceutical industry and strong experience in managing relationships with advocacy and diverse groups
- Strong team player, willing to share information and ideas.
- Knowledge of GCPs and ICH guidelines and clinical operations.
- Ability to travel with overnight stays, as necessary.
- Ability to effectively work in a global environment.
- Ability to interface professionally with a wide spectrum of internal and external professionals.
- Ability to work on multiple projects with aggressive timelines.
- Ability to demonstrate operational excellence, innovative thinking, scientific mindset and strategic thinking.
- Strong presentation and communication skills.
- Good understanding of regional regulations.
- Knowledge in clinical trials methodology.
- Bilingual skills (e.g. Spanish), would be highly beneficial
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.