What are the responsibilities and job description for the Director, Trial Site & Participant Engagement Group Lead position at BioSpace?
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview
The Director, Clinical Trial Site Engagement and Participant Insights (CTSEPI) is a member of the Clinical Program Optimization and Innovation (CPO&I) team within the Development Operations (Dev Ops) organization. The Director, CTSEPI will play a crucial role in assessing site & participant burden of Insmed clinical trials and working cross functionally on mitigations strategies. This work will support our goal of establishing and fostering relationships with clinical trial site staff and enhancing clinical trial participant support and engagement. This position involves working closely with clinical trial sites and internal teams to ensure smooth trial operations and high levels of site and participant satisfaction. The role will partner with the Head of CPO I to create the vision and strategy for this newly created function, ensuring it is centered around the needs of our clinical trial sites and participants. The primary focus for the role will be to facilitate deepening of the Insmed relationships with our clinical trial sites in an aim to enhance their experience when participating in an Insmed clinical trial. Additionally, there will be an expectation for the role to provide “white glove” service to our clinical trial sites by actively listening to their needs, responding to their requests, and proactively identifying future opportunities for support. At the site-level, this role will build trust, garner insights, resolve trial-related issues, and facilitate communication with an aim to alleviate site burden and accelerate participant recruitment to ensure Insmed and our clinical trials stand out in the pool of Sponsors the sites work with. The Director, CTSEPI will elevate Sponsor/Clinical Site collaboration by building direct relationships with the Investigators, Research Coordinators, and other clinical site staff, encouraging transparent communication and optimizing the execution of our clinical trials on a global level. At the clinical trial participant-level, this role will work in a blinded fashion to solicit insights, establish avenues for provision of feedback, and engage participants before, during, and after they participate in an Insmed clinical trial. The Director, CTSEPI will ensure participant feedback is communicated to the clinical study team (CST) for consideration during the design and execution of Insmed clinical trials with the aim to make participation in an Insmed clinical trial a positive experience. Identifying lessons learned and best practices and working to incorporate them into our clinical trial operations prospectively will be an important aspect of this Role. To avoid duplication of effort and streamline site interactions, this role will work with other internal and external site facing stakeholders/collaborators to coordinate interactions and define roles and responsibilities. In support of this work, the role will establish and manage a master site interaction database to document interactions and capture key discussions points. The database will be made available to study team members and key internal stakeholders e.g., Medical Affairs staff interacting with our clinical trial sites. The CTSEPI role will also be responsible for planning site interactions at scientific congresses and conferences. They will work with sites, clinical study teams, and external vendors to arrange the logistics in support of the interactions. This role is required to have strong foundational knowledge and experience in Clinical Operations, Development Operations or Clinical Trial Site Engagement and Patient Insights to facilitate their ability to support the clinical trial sites and participants. They will work collaboratively with Dev Ops and cross-functional team members to drive the goal of enhancing the experience of the clinical trial sites and participants during conduct of Insmed clinical trials. The Role is focused on North American clinical trial Sites and participants but has potential to grow and cover additional regions in the future. As such, this Role must have a working knowledge of clinical trial operations in Europe. Exposure to additional regions (e.g., South America, LatAm, Asia Pacific) would be beneficial.
Responsibilities
Group Lead:
179000-250800
Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:
Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview
The Director, Clinical Trial Site Engagement and Participant Insights (CTSEPI) is a member of the Clinical Program Optimization and Innovation (CPO&I) team within the Development Operations (Dev Ops) organization. The Director, CTSEPI will play a crucial role in assessing site & participant burden of Insmed clinical trials and working cross functionally on mitigations strategies. This work will support our goal of establishing and fostering relationships with clinical trial site staff and enhancing clinical trial participant support and engagement. This position involves working closely with clinical trial sites and internal teams to ensure smooth trial operations and high levels of site and participant satisfaction. The role will partner with the Head of CPO I to create the vision and strategy for this newly created function, ensuring it is centered around the needs of our clinical trial sites and participants. The primary focus for the role will be to facilitate deepening of the Insmed relationships with our clinical trial sites in an aim to enhance their experience when participating in an Insmed clinical trial. Additionally, there will be an expectation for the role to provide “white glove” service to our clinical trial sites by actively listening to their needs, responding to their requests, and proactively identifying future opportunities for support. At the site-level, this role will build trust, garner insights, resolve trial-related issues, and facilitate communication with an aim to alleviate site burden and accelerate participant recruitment to ensure Insmed and our clinical trials stand out in the pool of Sponsors the sites work with. The Director, CTSEPI will elevate Sponsor/Clinical Site collaboration by building direct relationships with the Investigators, Research Coordinators, and other clinical site staff, encouraging transparent communication and optimizing the execution of our clinical trials on a global level. At the clinical trial participant-level, this role will work in a blinded fashion to solicit insights, establish avenues for provision of feedback, and engage participants before, during, and after they participate in an Insmed clinical trial. The Director, CTSEPI will ensure participant feedback is communicated to the clinical study team (CST) for consideration during the design and execution of Insmed clinical trials with the aim to make participation in an Insmed clinical trial a positive experience. Identifying lessons learned and best practices and working to incorporate them into our clinical trial operations prospectively will be an important aspect of this Role. To avoid duplication of effort and streamline site interactions, this role will work with other internal and external site facing stakeholders/collaborators to coordinate interactions and define roles and responsibilities. In support of this work, the role will establish and manage a master site interaction database to document interactions and capture key discussions points. The database will be made available to study team members and key internal stakeholders e.g., Medical Affairs staff interacting with our clinical trial sites. The CTSEPI role will also be responsible for planning site interactions at scientific congresses and conferences. They will work with sites, clinical study teams, and external vendors to arrange the logistics in support of the interactions. This role is required to have strong foundational knowledge and experience in Clinical Operations, Development Operations or Clinical Trial Site Engagement and Patient Insights to facilitate their ability to support the clinical trial sites and participants. They will work collaboratively with Dev Ops and cross-functional team members to drive the goal of enhancing the experience of the clinical trial sites and participants during conduct of Insmed clinical trials. The Role is focused on North American clinical trial Sites and participants but has potential to grow and cover additional regions in the future. As such, this Role must have a working knowledge of clinical trial operations in Europe. Exposure to additional regions (e.g., South America, LatAm, Asia Pacific) would be beneficial.
Responsibilities
Group Lead:
- Be a thought leader in site enablement and participant experience, driving innovative solutions and best practices.
- Set the foundational strategy for the group.
- Define and implement key expansion strategies for CTSEPI to enable continued growth within the US and potentially globally to offer our sites and participants best-in-class solutions to enhance their clinical trial experience.
- Develop, communicate, and execute CTSEPI Strategies/Plans working closely with the CST and key internal stakeholders throughout the life cycle of the clinical trial.
- Develop & maintain relationships with site engagement organizations; assist identification of high-performing sites and key opinion leaders that can contribute to forums, boards and/or discussions.
- Stay updated on industry trends and best practices in clinical trial site and participant engagement.
- Network with clinical trial related professional associations and site-focused groups.
- Mentor and support junior team members in their professional development.
- Partner internally, cross-functionally, and externally to deliver key initiatives.
- Represent CTSEPI on internal and external collaborations.
- Attend key therapeutic training/meetings and/or industry training.
- Establish and maintain strong relationships with clinical trial sites to maximize their performance and engagement during conduct of clinical trials.
- Create platform and process for sites to provide feedback on things like the participant journey, trial operational feasibility, CROs/Suppliers and experience with Insmed as a Sponsor.
- Serve as a central point of contact for clinical trial sites for issue resolution and provide white glove service.
- Support the CST in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial roadblocks, and using motivational tactics to ensure the timely delivery of trials.
- Engage, evaluate, and develop a network of high-performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of activities thereby increasing their desire to partner with Insmed.
- Establish objective measures to assess our clinical trials from a site and participant perspective and identify opportunities for improvement e.g., site related cycle time metrics, protocol/site burden index
- Provide site related feedback to Clinical Trial Operations during the selection and qualification of new clinical trial sites.
- Serve as a centralized source of knowledge regarding clinical trial site feedback and incorporates that feedback, where appropriate, on future trials.
- Establish and manage a site coordinator protocol input committee. The committee will be therapeutic area agnostic and provide early input regarding trial design and Schedule of Assessments.
- Travel to sites on an on-going basis to establish and maintain strong working relationships.
- Attend key scientific congresses and conferences to manage site-related interactions and sessions to enhance knowledge in therapeutic areas.
- Identify and work with suppliers to engage participants (e.g., conduct surveys), analyze data collected and make recommendations re: our trials.
- Create a platform and process for participants to provide feedback on their experience e.g., likes/dislikes, ePROs, devices, travel reimbursement policy.
- Partner with the Patient Advocacy Group to engage with patients at internal meetings e.g., Town Hall meetings to motivate the team.
- Partner with Compliance to identify and develop compliant ways of engaging trial participants (before, during, and after participation)
- Provide white glove support and serve as a central point of contact for the suppliers/sites to bring forward the voice of the participant for issue resolution.
- Share Lessons Learned across Insmed Teams.
- Work with the clinical trial sites to proactively address participant needs during study planning and start-up and throughout conduct of the clinical trial
- Bring forward to the CST additional areas of opportunity to support participants during conduct of the clinical trial.
- Ensure the CST takes participant burden into account during creation of clinical trial protocols, specifically during creation of the Schedule of Assessments.
- Establish objective measures to assess our clinical trials and identify opportunities for improvement (e.g., patient-burden index, engagement and satisfaction goals)
- Serve as a centralized source of knowledge regarding participant feedback and incorporate that feedback, where appropriate, on future trials.
- Establish clear roles and responsibilities for CTSEPI Team Members, CRO Staff, Medical Affairs Field Force/MSLs, Clinical Development/Clinical Science, and Patient Advocacy regarding engagement of site staff with the goal to ensure site staff are engaged thoughtfully and, as much as possible, Insmed shows up consistently and speaks with one voice.
- This Role may identify and partner with 3rd party service providers as needed e.g., engaging a 3rd party service provider to survey clinical trial participants for their feedback.
- Qualified candidates must have a bachelor's degree from an accredited college or university. Advanced degree is preferred.
- Minimum of 12 years of progressive experience in Clinical Operations or Development Operations with a Sponsor/CRO company is required with a minimum of 3 years of experience as a Clinical Trial Site and/or Participant Liaison/Engagement Lead.
- Proven ability to build a team and set its mission, vision and strategy.
- Understanding of end-to-end clinical trial processes is required.
- Knowledge of clinical trial regulations and guidelines (e.g., GCP, FDA, EMA).
- Demonstrated knowledge in innovative clinical trial site and participant centric solutions.
- Strong strategic planning and execution capabilities.
- Strong organizational and problem-solving abilities.
- Proven influencing and negotiation skills.
- Ability to work collaboratively in a global environment to achieve quality and timeline metrics.
- Sound judgment and decision-making capabilities.
- Strong leadership skills with the ability to demonstrate flexibility and agility working within a multi-functional, global matrix.
- Excellent communication skills (verbal and written), and interpersonal skills.
- Must possess critical thinking skills for problem solving, conflict resolution, collaboration, and leadership tasks.
- Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
- Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
- Must successfully exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.
179000-250800
Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:
- Flexible approach to how we work
- Health benefits and time-off plans
- Competitive compensation package, including bonus
- Equity Awards (Long-Term Incentives)
- Employee Stock Purchase Plan (ESPP)
Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Salary : $179,000 - $250,800
