Allison Ivy Colvin, PhD

• Serves as a leader as part of the global clinical development team, to co-develop, manage, and implement strategic plans to support Pliant clinical trial education, recruitment, enrollment, and retention
• Continues to serve as people leaders for the global Clinical Science Liaison team
• Provides medical and scientific leadership to support the ongoing development and future commercialization of Pliant products
• Supports business development due diligence and assessment
• Provides global functional leadership, creating effective processes and engagement plans that are customized as needed for global regions
• Leads the generation and dissemination of scientific data through publications, presentations, and other communication channels
• Manages the Medical Affairs budget and effort allocation to ensure key scientific & medical activities are supported and executed according to the company’s timelines
• Develops clinical site engagement communications and presentations for site initiation, office visits, investigator meetings, and advisory boards to enhance current and future clinical trial awareness
• Identifies and communicates key clinical trial issues and insights to appropriate functional stakeholders to help influence clinical trial execution
• Fosters strong collaboration with the Pliant commercial team to ensure alignment of medical and commercial objectives
• Collaborates with Development Operations, Clinical Development, and external stakeholders to
  support clinical needs and monitor study performance and progress
• Facilitates identification of clinical trial site and community educational needs for Pliant clinical trials

• Serves as a people leader for the global clinical science liaison team, training and empowering the team to co-develop, manage, and implement strategic plans to support clinical trial education, recruitment, enrollment, and retention

Key Achievements

• Pioneered development and implementation of innovative, strategic platform using AI and omnichannel capabilities to guide medical field engagement aligned to unmet medical needs of PAH healthcare community
• Implemented and led a Johnson & Johnson (J&J) cross therapeutic area (TA) workstream that developed standards for compliant MSL support of clinical trials in partnership with R&D across J&J's 6 TAs
• Led development and implementation of innovative, MSL clinical trial recruitment support initiative aligned to respective clinical trial targets
• Supported MSL team readiness for the product launch of Opsynvi
• Served as a contributor of the J&J Pulmonary Hypertension (PH) Sponsor of Choice Project (Goal: optimize PH clinical trial support)
• Supported development of PH omnichannel initiatives
• Served as KOL Engagement Core Team Member
• Served on a Cross-TA team charged with the development of pan-J&J/COVID-19 field resources for medical
• Fostered environment of recognition by championing “Coach of the Quarter” (Leadership) award
• Implemented strategies in support of diversity and inclusion in PH clinical trials
• Developed MSL training initiatives and professional development opportunities for MSL team and MSL leadership (e.g., MSL Lead Role program)
• Identified additional opportunities for strategic MSL field engagement during stay-at-home orders due to COVID-19

Primary responsibilities include:

• Led the development and execution of strategies for the engagement of opinion leaders to support the J&J PH organization. Responsible for overseeing the tactical execution to ensure field teams were delivering timely and impactful data communication to external stakeholders in accordance with current regulatory and health care compliance guidelines.
• Provided strategic leadership for the national J&J PH MSL team consisting of 4 Regional MSL Directors and 18 MSLs.
• Defined and implemented vision for medical field engagement and TA field strategy while also collaborating closely with key internal and external stakeholders
• Performed FTE and budget needs assessments
• Ensured appropriate resource allocation within PH MSL team
• Developed innovative strategies for stakeholder interactions that result in mutually beneficial relationships through medical insights, advisory boards, and other customer engagement meetings
• Cultivated culture of innovation by promoting creative thinking and encouraging employees to take calculated risks in pursuit of solutions.
• Developed and executed MSL launch strategies for new products and line extensions
• Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
• Ensured optimal territory plans are established and executed to meet business needs and maintain relationships with local stakeholders
• Implemented systems and tools to support performance analysis, customer interaction reporting, and account planning to ensure optimal performance
• Collaborated with internal business partners (US and Global Medical Affairs, Communications, Commercial, Compliance, etc.) to ensure field teams can deliver on medical objectives and support evidence generation needs across portfolio
• Served on Medical Leadership Team to represent MSL function, provide input into overall medical strategy, and ensure alignment across medical functional teams
• Worked closely with VP of Medical Affairs to plan and implement departmental processes and goals in support of corporate objectives
• Facilitated MSL team support of evidence generation (e.g., company-sponsored trials, investigator-initiated studies, registries) in collaboration with US Medical Affairs and R&D for early and late-stage development products
• Led strategic development and implementation of disease-related assets and field strategies for PH MSL team
• Monitored and anticipated changing therapeutic and healthcare environment impacting opinion leaders and other healthcare professional's (HCPs) understanding of products’ data
• With a high level of scientific acumen, identified and initiated opportunities to address OL and other HCP’s educational gaps and research opportunities
• Synthesized MSL applicable scientific information (e.g., basic science, clinical trial and real-world evidence) to lead development of educational materials/communication tools and champion regulatory/legal/HCC approvals
• Identified research opportunities for the MSL team and partnered with the R&D and Medical Affairs teams to develop a pan-J&J MSL support plan/guidance document
• Served as point of contact for key partnering responsibility with functional leaders (e.g., clinical/R&D, Medical Affairs, Marketing, HCC/Legal/Regulatory, etc.)
• Provided scientific leadership and support to Medical Affairs Department on a variety of projects and programs
• Provided leadership support to MSL Field Directors to ensure recruiting and hiring of a qualified and diverse work force and to ensure team retention through development, motivation and inspiration
• Provided coaching to people leaders to inspire teams and provide support with challenges
• Built MSL scientific acumen for new disease state, marketed, and pipeline products

Key Achievements

• Managed team of 9 MSLs (US East region) providing medical field support for pulmonary arterial hypertension (PAH) franchise
• Supported MSL team readiness for two product launches (Opsumit, 2013 and Uptravi, 2015)
• Developed MSL “Lead Role” program which supports MSL professional development and aligns to individual MSL strengths
• “Circle of Excellence” award recipient
• Developed and managed National MSL dashboard showcasing qualitative and quantitative MSL highlights and metrics (monthly)
• Assumed Senior MSL Director responsibilities and co-led National MSL team initiatives from August 2015 – June 2016, as well as Feb 2018 – April 2018, in absence of Senior MSL director. Managed both MSL Director and Senior Director responsibilities.

Senior MSL Director primary responsibilities included:

• Developed MSL goals, objectives, and incentives aligned to US medical affairs strategies
• Coordinated MSL support of US and global medical affairs initiatives (e.g., PAH advisory boards, international MSL congress support and medical deliverables, global medical affairs MSL internship, etc.)
• Provided MSL leadership representation and presentation of MSL initiatives during US and global business planning meetings
• Developed and managed MSL metrics database (Steeprock/Veeva)
• Developed monthly metric and query reports supporting national MSL team’s activities to identify medical field trends for executive leadership and brand team visibility
• Provided MSL leadership representation during cross-functional meetings (e.g., medical leadership team, medical brand teams, commercial / access team, etc.)
• Developed and managed MSL budget
• Developed KOL compliance reports
• Executed and led monthly MSL national teleconferences, as well as live MSL training meetings

MSL Director primary responsibilities included:

• Identified, developed, assured execution, and communicated field impact of key regional MSL initiatives
• Supported PAH Franchise by aligning MSL field initiatives with ERA and prostacyclin medical affairs goals and strategies
• Supported clinical trial and research initiatives by working to garner early MSL involvement in clinical trials and align with US and global medical affairs on effective MSL clinical trial support measures
• Identified, executed, and supported initiatives that support reactive communication of impactful Actelion data / publications
• Communicated and liaised with US and global medical affairs on MSL training and MSL tools for upcoming publications and congress presentations
• Developed and supported MSL goals which encourage application of best-in-class behaviors.
• Provided support for MSL professional development by identifying opportunities for MSLs to lead and / or participate in roles/projects
• Supported development and execution of individualized MSL development plans, as well as MSL lead role opportunities
• Delivered constructive feedback and coaching in a professional manner with high degree of social intelligence
• Evaluated and encouraged “Best-in-Class” MSL behaviors to help increase overall MSL effectiveness
• Supported next-level training initiatives
• Supported execution of regional MSL territory plans, worked compliantly with cross-functional leadership, and initiated/participated in leadership initiatives
• Provided ongoing support of cross-functional field structure and field leadership Team
• Provided MSL director field presence for KOL support/field visits, when warranted (e.g., KOL support/field visits)
• Ensured MSL compliance and operational support
• Developed MSL activity reports reflective of MSL field presence

Key Achievements:

• Managed team of MSLs for US East region
• Served as MSL Associate Director lead for Veletri; led development of several educational initiatives in preparation for launch.
• Worked with regional business director in developing business planning template for new Customer Care Area (CCA) business structure

Primary responsibilities included:

• Worked with US medical affairs senior management and MSL team, as appropriate, on special projects, committee representation, and educational and training activities
• Worked cross functionally with senior sales and marketing management to ensure proper alignment of Actelion business goals
• Promoted and coordinated regional MSL participation with cross-functional groups by assigning MSLs activities for MSLs related to US medical affairs, clinical operations, sales and marketing
• Directly supervised and managed performance and professional development of regional MSL Team
• Supervised and managed performance of MSL activities within field, including face-to-face field visits/meetings when needed, ensured team fiscal responsibility, and completed midyear and annual written performance evaluations
• Helped with development, drafting, and roll out of company standard operating procedures, guidelines and policy statements affecting Medical and other departments
• Served as role model for MSL team and company, demonstrating leadership and strategic clinical acumen as it relates to Actelion’s interests

Key Achievements

• Chosen to attend General Leadership Development Center; Winner of the 2008 “Judgment and Decision Making” Competency; Winner of the 2008 Case Study Competition; Served as MSL clinical trial lead for two iloprost studies (PROWESS-15 and INHALE-15)

Primary responsibilities included:

• Fostered and developed relationships with Key Opinion Leaders (KOLs) in the academic and clinical environments within territory (NC/SC)
• Served as MSL lead for two studies (Global and US) in a cross functional capacity
• Served as a field-based clinical/scientific resource for field sales personnel, marketing, and clinical organizations, as appropriate
• Responded to unsolicited requests for medical information
• Disseminated and conveyed complex information to professional audiences
• Developed and executed medical educational program, symposia, and speaker programs
• Worked cross functionally, as needed, with clinical operations and affiliated research
• Assisted with field training of colleagues as needed
• Liaised between investigator and company regarding the interest and execution of investigator-initiated studies
• Strategically managed territory and projects

• September 2004 - March 2006: Boston, MA - Acute Care Pharmaceuticals (ACP)/Levosimendan (Late phase III development for acute heart failure) franchise
• March 2006 – February 2007: Charlotte, NC -Dyslipidemia (Tricor & Tarka) franchise

Key Achievements

• Chosen to lead US/international MSLs and served as booth captain at European Society of Cardiology Congress in Stockholm, Sweden (05’)

Primary responsibilities included:

• Developed and maintained professional relationships with KOLs and academic institutions within New England (Levosimendan) and North Carolina (Tricor) in therapeutic areas of commercial and research interest
• Worked closely with internal customers to develop and execute business plan designed to meet shared business objectives
• Disseminated and conveyed complex medical and scientific information to professional audiences
• Developed strategic tactics for communicating complex scientific information to healthcare community
• Provided necessary clinical support for Abbott ACP products in prioritized managed care accounts when appropriate
• Uncovered scientific data that may have potential for publication and/or abstract presentation
• Worked closely on IIS program
• Served as scientific resource to sales (Tricor), marketing and clinical, as appropriate
• Provided support for answering unsolicited medical questions, adverse event follow through, and other clinically related medical information issues
• Maintained internal KOL database and clinical data repository through critical information data input on consistent basis

Projects: Elucidating the structure and function of voltage-gated potassium channels by employing molecular biological, biochemical, and electrophysiological approaches. Collaborative research studies focus on the relationship between lipids and parasympathetic modulation in murine atrial cells.