Project Management Business Development
Resume:
SANDRA LEE COLLIER
DIRECTOR- GLOBAL SALES/CLINICAL PROJECT MANAGEMENT
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PROFESSIONAL EXPERIENCE SUMMARY
25+ years Pharmaceutical/ Medical Device/AI Clinical Research and Business Development
8+ years Director Clinical Project Management, 10+ years of Project Management
Results-Driven Sales Executive with $100 Million in Sales/ Business Development
Develop & manage the Global Sales and Project Management (PM) budgets
Exceptional leadership, organizational, oral, and written communication, analytical, problem-solving, and time management skills
Highly successful in both independent and collaborative work environments
Experienced Value-Based Care healthcare professional
Lead teams in identifying potential vendors, Sponsors, and CROs for clinical trial execution.
Collaboratively create/issue Request for Proposals/Information (RFPs) and (RFIs).
Compile responses and facilitate team review of proposals from clinical trial vendors.
Lead efforts to expand lead generation through cold calling, email campaigns, business-to-business selling, and other methods
Manage leads through the sales cycle promptly, routing and assigning duties and follow-up actions to internal stakeholders
Develop and implement strategic business development plans to maintain/grow key client business relationships in collaboration with internal stakeholders
Achieve revenue and sales objectives through proactive communication and management of sales opportunities for targeted and assigned clients
Maintain and update information within the Salesforce platform to support BD pipeline review and reporting
Ensure leads and active opportunities are accurate in the Salesforce platform for BD report generation
Direct members of the team and perform necessary activities related to the timely response of RFPs, RFI, and ballpark budgets
Perform competitive bid analysis and provide recommendations to operational teams.
Participate in pricing negotiations for Sponsors, CROs, Central Laboratories, Imaging, ePRO, and other critical study vendors.
Lead and facilitate cross-functional reviews and vendor selection meetings.
Outstanding relationship-building and management skills
Ability to work on multiple projects at the same time.
Drive to deliver results and true client satisfaction.
Comfortable working virtually across multiple geographies and cultures, across time zones, in a highly dynamic organization.
Strong analytical capabilities, combining the ability to dive deep into data and anecdotal feedback, analyze the status quo, and synthesize findings.
Strong organizational skills and capacity to prioritize and escalate in a complex, fast-paced environment.
Hands-on approach, showing attention to detail and ownership.
Proven track record interacting with multiple stakeholders at all levels of an organization, establishing effective relationships.
Great communication skills-written and verbal, combined with the ability to moderate large forums, facilitate dialog with stakeholders, and present outcomes and risks.
Highly organized and detail-oriented with strong analytical skills and the ability to prioritize and manage differing needs of the business organization.
In-depth knowledge of business development, bid defense, clinical research processes, action item tracking, project status reports, auditing, and resource demand
Highly dedicated, innovative, and self-motivated team player/team builder
Prioritize workload, focus, and follow through on problems and commitments
Excellent analytical and interpersonal skills
Manage & advance Global Sales and PM team talent with an emphasis on developing, improving, or enhancing PM processes & initiatives
Create consistent best practices across the Sales/GPM teams and establish measures to ensure individual, project, and Sales Success
Enhance engagement with functional areas and executive management, leading to new opportunities for the Sales and GPM teams
Drive allocation of resource assignments; assess & define future Sales and PM team growth
Collaborate with the Sales and Portfolio Management & Operations (PMO) teams to establish best practices for project metrics and reporting; regularly assess Global Sales and PM performance and recommend modifications as appropriate
Oversee management of Global Sales and PM Initiatives
Collaborate with the GPPM Portfolio Management & Operations (PMO) team to establish GPPM best practices for project metrics and reporting; regularly assess GPM performance and recommend modifications as appropriate
Oversee management of GPM initiatives led by GPM team members; ensure successful completion of activities. Develop & manage GPM budget
Strong knowledge of Windows-based operating systems, SharePoint, Smartsheet’s, EPIC, Salesforce, and other software applications
THERAPEUTIC EXPERIENCE
Oncology: Advanced Solid Tumors, Breast Cancer, CAR-T, Radiolabeling, Metastatic Melanoma, Ovarian, Lymphoma, NSCLC, Cholangiocarcinoma (Intrahepatic, Perihilar, and Extrahepatic Cholangiocarcinoma), Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, and GEJ Adenocarcinoma,
Respiratory: COPD (Moderate, Severe, Very Severe), Asthma, IPF
Ophthalmology: Wet-AMD, Macular Degeneration, Diabetic Macular Edema, Retinitis Pigmentosa
Dermatology: Glabellar Lines, Atopic Dermatitis, Pruritis, Prurigo Nodularis, Plaque Psoriasis
Endocrine/Metabolic: Diabetes I/II, Gestational Diabetes, CGM, Obesity
Infectious Disease (Vaccines): Herpes Simplex 1, COVID, HIV
Mental Disorders: Generalized Anxiety Disorder (GAD), Major Depressive Disorder (MDD), ADHD, Schizophrenia
Circulatory: CHF, PAD, Hypertension, Preeclampsia, Cardio-Pulmonary Disease,
Central Nervous System/Pain Disorders: Migraine, DPNP, Chronic Pain, Epilepsy, Fibromyalgia
Certifications
PMP-pending, Rare Disease, Orphan Drug, First-In-Human, Pediatrics, Controlled Substances, PRIME (Priority Medicines), Risk-Based Monitoring
EDUCATION
Xavier University, Cincinnati, OH
Master of Science in Nursing (Nurse Practitioner) and Doctor of Pharmacy
(Expected Graduation 2028 - in progress)
North Carolina Agricultural and State University, Greensboro, NC
Bachelor of Science, Accounting
Memberships – BWIPM, APM, IAPM, ACRP
PROFESSIONAL EXPERIENCE
Insilico Medicine
Director- Global Sales and Clinical Project Management Feb 2023-Current
Identify and drive opportunities to innovate and build efficiency
Develop and implement clinical specialty project plans and timelines
Maintain project plans for ongoing projects and escalate risks to leadership when necessary
Devising and implementing systems to keep staff motivated and maintain a high level of morale
Identifying opportunities by keeping track of competitor activity
Using industry knowledge to identify potential new markets and increase the market share
Collaboratively create and issue Request for Proposals (RFPs).
Overall management of the Client Services department includes proactively identifying resourcing needs, monitoring FTE workload relative to billability expectations, screening and hiring candidates, training on departmental responsibilities and expectations, and establishing comprehensive retention strategies to keep staff motivated and productive. Including providing mentorship and guidance to project management staff and fostering a culture of continuous learning and professional development.
Oversee the Project Management team in ensuring high quality, on-time deliverables, proactive communication, and efficient issue resolution.
Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management
Oversee the creation and delivery of client-facing materials, including presentations, agendas, minutes, and reports
Ensure cross-functional internal teams are provided with the information and tools needed to ensure their ability to launch and support projects both initially and throughout the project duration
Ensure contractual obligations to each client are understood, and those expectations are met (to exceed) while minimizing unnecessary scope creep and ensuring efficient resource utilization
Establish and manage processes, key performance indicators, and quality standards to ensure optimal client service, operational quality, and efficiency.
Identify opportunities for process improvement and implement best practices to enhance the efficiency and effectiveness of clinical trial operations
Support developing and maintaining Client Services-specific Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure products and services are developed and delivered consistently to meet customer and applicable statutory and regulatory requirements.
Attend off-site meetings and conferences as needed
Support Business Development efforts by providing input into proposals and related budgets in meetings with internal/external stakeholders and prospective clients
Compile responses and facilitate team review of proposals from vendors.
Develop study-related trackers and monitoring tools.
Manage Teams of various sizes (5-15 countries-- full service) and large (>15 countries, full service) projects/programs with primary responsibility for Sales/PM deliverables in conformance with the predefined quality standards and on a time budget
Supervisory responsibility to produce project deliverables in conformance with the predefined quality standards, on time and budget, adhering to and promoting principles of delivery and service in dealing with customers
Primary Escalation contact for customers, vendors, project teams, and representatives of other functional areas for all project-related issues
Training, mentoring, and coaching of Project Managers
Participation in feasibility research, RFPs and RFIs
Assistance in sales/business development tasks, such as the development of proposals, client presentations, bid defense meetings, and product displays
Implementation of company standard practices and compliance with intradepartmental procedure
Management of the operational activities at selected participating institutions for multiple US based IP/IDE pre market clinical and post market investigations. Function as a critical member of the clinical trial team, interacting closely with clinical trial managers and data managers
Acting as a point of contact between customers and companies
INNOVADERM Research
Senior Clinical Project Manager Mar 2021 – Feb 2023
Management of the operational activities at selected participating institutions for multiple US based IDE pre market clinical and post market investigations. Function as a critical member of the clinical trial team, interacting closely with clinical trial managers, data management, and CRA colleagues
Partnering closely with clinical operations, clinical development, regulatory, and other team members, developing and maintaining project plans, timelines, and dashboards/trackers for multiple clinical programs aligned with program, department, and corporate objectives.
Schedule and lead team meetings, including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion.
Support ongoing program management initiatives and best practices by utilizing and creating project management tools and templates.
Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment.
Identify, define, score, and communicate risks for each project/program as part of an overall risk registrar with risk mitigation and contingency plans, as required.
Working cross-functionally, coordinating with vendors and external partners to track, manage, and escalate, as needed, ongoing and upcoming projects with a focus on on-time delivery.
Ensure project deliverables are met with required quality and timeline attributes.
Track vendor performance, manage contracts, and address issues as they arise while nurturing short-term and long-term positive relationships.
Facilitate communication between vendors and internal cross-functional teams, including management of overall governance meetings with key vendors.
Provide input into and develop study-related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, eCRF completion guidelines, patient diaries, recruitment plans, and ICFs.
Ensure proper clinical trial conduct in accordance with the Monitoring Plan, prevailing laws, and Good Clinical Practices standards to achieve project goals, timelines, and quality.
Manage assigned operational aspects for implementation of clinical trial activities at assigned sites study start-up through database lock, ensuring relevant timelines and quality deliverables are met
Identify, evaluate, and select investigator sites as needed
Interface with the study team, facilitate information flow between study team, vendors
And assigned investigator sites.
Conduct study start-up (SSU) activities, including completing the Investigator Initiation Package (IIP), establishing the site budget, negotiating contracts, and ensuring timely management of emerging issues that may compromise the time to site activation.
Participated in mentorship and assigned lead tasks. Participated in business development proposals and bid defense meetings.
Proactively suggested potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.
Identify operational efficiencies and process improvements.
Develop study and country-level informed consent forms
Collaborated with the RWLP Regulatory team to ensure updated regulatory information was applied and shared. Participated in bid defense meetings
Provided input into Requests for Proposals (RFPs), scope, and budgeting. Develop site management strategy.
Participated in eCase Report Form design and edit check development.
ICON Clinical Research
Senior CRA/ Site Manager 2018 - 2021
Management of the operational activities at selected participating institutions for multiple US based IDE pre market clinical and post market investigations. Function as a critical member of the clinical trial team, interacting closely with clinical trial managers, data management, and CRA colleagues
Identification, evaluation, selection, initiation, monitoring, and close-out of assigned clinical trial investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and standards.
Clinical trial monitoring and managing investigator-site relationships to ensure effective delivery of clinical trials (e.g., site activation, enrollment, database release), safeguard the quality of investigator sites (e.g., patient safety, site health), maintain investigator and site staff engagement and satisfaction, and enhance the company’s image with stakeholders.
Resolution of all protocol-related issues for the assigned investigator
Sites and works closely with study team members as required in setting up, running, and closing out clinical trials.
Provide input into and develop study-related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, eCRF completion guidelines, patient diaries, recruitment plans, and ICFs.
Ensure proper clinical trial conduct in accordance with the Monitoring Plan, prevailing laws, and Good Clinical Practices standards to achieve project goals, timelines, and quality.
Manage assigned operational aspects for implementation of clinical trial activities at assigned sites study start-up through database lock, ensuring relevant timelines and quality deliverables are met
Identify, evaluate, and select investigator sites as needed
Interface with the study team, facilitate information flow between study team, vendors
And assigned investigator sites.
Conduct study start-up (SSU) activities, including completing the Investigator Initiation Package (IIP), establishing the site budget, negotiating contracts, and ensuring timely management of emerging issues that may compromise the time to site activation.
Participated in mentorship and assigned lead tasks. Participated in business development proposals and bid defense meetings.
Proactively suggested potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.
Identify operational efficiencies and process improvements.
Develop study and country-level informed consent forms
Collaborated with the RWLP Regulatory team to ensure updated regulatory information was applied and shared. Participated in bid defense meetings
Provided input into Requests for Proposals (RFPs), scope, and budgeting. Develop site management strategy.
Participated in eCase Report Form design and edit check development.
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Provided input into and developed study-related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRFs, eCRF completion guidelines, patient diaries, recruitment plans, ICFs, and other study plans as needed.
Ensured proper conduct of clinical trials in accordance with the Monitoring Plan, prevailing laws, and Good Clinical Practice standards to achieve project goals, timelines, and quality.
Managed assigned operational aspects for implementing clinical trial activities at assigned sites from study start-up through database lock, ensuring relevant timelines and quality deliverables were met.
Managed external vendors.
Interfaced with the study team, facilitated information flow between study team, vendors
And assigned investigator sites.
Performed site personnel development, coaching, and training; conducted protocol and addressed protocol-related questions from site staff.
Attend investigator meetings when required.
Developed and implemented effective site recruitment plans, provided enrollment support, and Partnered with the study team to define and support recruitment initiatives.
Monitored site-level AEs and SAEs, collaborated with the Drug Safety Unit, and followed up to resolve SAEs.
ARMO BioSciences 2015 - 2018
Executive Sales and Project Manager
Oversee Clinical Trials during all phases of Investigator product and Medical Device development, including Subject Treatment and Device implantation.
Monitored investigator sites with a particular ability to manage complex studies and challenging sites to ensure the accuracy and validity of eCRF entries.
Provided mentoring and support to less experienced members of the project team and advice on training and quality issues.
Assisted colleagues with site visits and conducted site calls.
Served as a resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues.
Generated and tracked enrollment status reports to ensure the study stays on track to meet enrollment goals.
Track study-specific status reports to ensure the monitoring team keeps all required information regarding site issues, deviations, and eCRF status current.
Performed Serious Adverse Event reconciliation and worked with the sponsor, study sites, study coordinators, and other CRAs to resolve discrepancies.
Reviewed outstanding data reports and worked with CRAs to ensure data collection was met per contractual guidelines.
Assisted the sponsor, study sites, and CRAs with audit preparation, responses, and quality issues.
Performed and coordinated assigned aspects of the clinical monitoring process by GCPs and global SOPs to assess the safety and efficacy of investigator products and medical devices.
Conducted site visits to determine protocol and regulatory compliance and prepare required documentation.
Developed collaborative relationships with investigative sites, sponsor personnel, and study vendors.
Management of the operational activities at selected participating institutions for multiple US based IDE pre market clinical and post market investigations. Function as a critical member of the clinical trial team, interacting closely with clinical trial managers, data management, and CRA colleagues
Identification, evaluation, selection, initiation, monitoring, and close-out of assigned clinical trial investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and standards.
Clinical trial monitoring and managing investigator-site relationships to ensure effective delivery of clinical trials (e.g., site activation, enrollment, database release), safeguard the quality of investigator sites (e.g., patient safety, site health), maintain investigator and site staff engagement and satisfaction, and enhance the company’s image with stakeholders.
Resolution of all protocol-related issues for the assigned investigator
Sites and works closely with study team members as required in setting up, running, and closing out clinical trials.
Provide input into and develop study-related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, eCRF completion guidelines, patient diaries, recruitment plans, and ICFs.
Ensure proper clinical trial conduct in accordance with the Monitoring Plan, prevailing laws, and Good Clinical Practices standards to achieve project goals, timelines, and quality.
Manage assigned operational aspects for implementation of clinical trial activities at assigned sites study start-up through database lock, ensuring relevant timelines and quality deliverables are met
Identify, evaluate, and select investigator sites as needed
Interface with the study team, facilitate information flow between study team, vendors
And assigned investigator sites.
Renua Medical USA May 2009 – Jun 2015
Project Manager: Clinical Strategy and Business Development
Provided a working knowledge of clinical research processes, Good Clinical Practices, the International Committee on Harmonization (ICH) Guidelines, the Code of Federal Regulations (CFR), and applicable local laws about clinical research investigations.
Provided audit and inspection support for assigned projects, including advising the project team during the preparation and conduct of audits and inspections, where feasible.
Oversee Clinical Trials during all phases of Investigator product and Medical Device development, including Subject Treatment and Device implantation.
Reviewed and provided feedback on project-related audit and inspection responses generated by project team members before finalization.
Developed and implemented innovative approaches for and participated in site recruitment, selection, and initiation activities.
Identified potential Principal Investigators and developed patient enrollment strategies with the project team and clinical trial sites.
Worked closely with Directors of Clinical Strategy and Business Development to perform appropriate client and therapeutic indication research to support proposal development.
Contacted clients to discuss timelines, questions, expectations, deliverables, etc.
Ensured appropriate and accurate mapping of client budget specifications.
Provided quality client deliverables to strict deadlines, participating in client calls related to requests for proposals, budget discussions, requests for information, etc., as needed.
Experienced in writing and editing clinical site agreements (CSA) (contracts) and informed consent reviews, including protocol amendments.
Managed all aspects of a clinical trial at all assigned clinical sites: trained site research coordinators and ensured adherence to professional standards, FDA protocols, safety regulations, and data integrity established for clinical research.
Identified operational inefficiencies and compliance risks (related to document management) that impacted the company, its products, customers, and patients.
Conducted market analysis and coordinated internal/external customers to ensure the successful development and execution of sales strategies and activities.
Developed long-term customer relationships and identified and capitalized on opportunities that immediately satisfied customer needs.
Understand business needs, demonstrate confidence, and use interpersonal skills to collaborate and secure new business partners.
Creating and managing project plan(s) for each project in conjunction with the Project Engineers
Led coordination and documentation of project team activities, including kick-off meetings, design review meetings, verification and validation activities, and cadaver labs for multiple projects within the group
Performing and maintaining market analysis by each product segment to identify new product offerings and line extensions to ensure the best product offering in the industry
Forecasting and inventory management for all projects and products in the group
Working closely with purchasing and operations departments to source products through the supply chain
Assisting Group Manager and Project Engineer in creating sales, surgeon, and management presentations in PowerPoint
Developing technique guides, product literature, brochures, and all sales support information
Working with Clinical R&D and Sales & Marketing to identify clinical research topics for each product
Planning, organizing, and executing courses and symposia for specific product introductions in conjunction with sales and clinical R&D
Obtaining market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represented the company professionally and upheld the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
IQVIA Quintiles Regional Sales Manager 2005 - 2009
Senior Sales Executive 2003 - 2005
Senior Sales Executive/ Regional Sales Manager:
National Sales Award Winner 2X, “Rep of the Year” and “Top Regional Manager”
Meet and exceed territory sales objectives.
Develop and implement sales strategies to maintain a high retention rate of existing accounts in the territory.
Build and cultivate excellent rapport with hospitals, surgical centers, physicians, and surgical personnel to maintain longstanding relationships.
Acting as a point of contact between customers and companies
Negotiating terms of sales and agreements and closing sales with customers
Gathering market and customer information to figure out the customer's needs
Responding to customer queries and resolving their objections to get them to make a purchase
Advising product developers on improvements to include in forthcoming product developments and discussing special promotions
Creating proposal documents as part of the formal bidding procedure
Inspecting inventory in stock and the quality of the product on display
Providing customers with detailed and accurate quotations and cost calculations
Effectively collaborate with peers to identify mutual opportunities and support customer relationships.
Develop and implement market development strategies and pursue leads to increase customer base.
Conducted and evaluated market research, including customer and competitor activities.
Leverage marketing materials, clinical evidence, and customer testimonials through consultative and value-based selling.
Be a resource to the surgical team, providing guidance and insight on the product and technical assistance.
Assess customer feedback for new products or modifications to existing products and report back to R&D, Operations, and Marketing.
Conduct quarterly business reviews to exhibit achievement of sales goals.
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