Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Position Summary:

The Associate Operational Excellence Director leverages expertise and knowledge to plan and manage initiatives and activities designed to lead teams through change management. The Associate Director develops and implements processes, standards or operational plans with the goal of operational excellence across the business collaborating across a group of diverse stakeholders. 

Essential Functions of the job include but are not limited to:

• Lead the planning, execution, and delivery of enterprise initiatives and cross-functional programs from initiation through close-out.
• Define project scope, objectives, deliverables, timelines, and success metrics in alignment with organizational priorities.
• Manage project risks, dependencies, and issues, escalating as appropriate to ensure successful outcomes.
• Apply structured project and program management methodologies to ensure consistent, predictable delivery
• Support the vision of and commitment to continuous improvement in operational excellence across all activities.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation.
• Lead stakeholders in root-cause problem-solving techniques to identify core process challenges.
• Lead the development of recommendations for process improvement, leveraging subject matter experts for critical input.
• Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
• Identify, develop and execute strategies for on-going and sustained improvement in operational functions, including identification of tools, systems, staffing or other resources, procedures, and communication.
• Partner on the design and implementation of new business processes with organizational context and priorities in mind.
• Lead organizational change management to ensure adoption and sustainability of process changes.
• Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion.
• Identify operational risks and lead implementation of mitigation plans.
• Ensure or lead the documentation of business process.
• Establish key performance metrics and dashboards for monitoring operational performance.
• Translate enterprise and functional strategies into actionable plans and roadmaps for enterprise initiatives.
• Support execution of transformation, process improvement, and operational effectiveness programs.
• Identify opportunities to improve efficiency, quality, scalability, and consistency across the organization.
• Ensure enterprise initiatives are aligned with governance requirements, quality standards, and regulatory expectations.
• Oversee or lead training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives.
• Standardizes best practices and processes across the organization to ensure consistency and sustainability.
• Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
• Develop and monitor key performance indicators (KPIs) to track progress and drive decision-making.
• Monitor adoption of process, system and organizational changes to ensure long-term and sustained adoption.

Qualifications:

Minimum Required:

• Bachelor’s degree (or its international equivalent) + 12 years of related experience

Other Required:

• Experience in CRO/pharmaceutical/biotechnology drug development or demonstrated competency in the key areas of the role
• Strong drug development experience with understanding of other functions relevant to the position.

 Skills:

• Excellent written and oral communication skills
• Strong strategic and analytical thinking
• Ability to prioritize critical needs
• Strong clinical operations and drug development experience
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms 

Competencies:

• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
• Exceptional analytical and problem-solving skills. Proficiency in data analysis and performance metrics.
• Highly organized with excellent presentation, oral and written communication skills.
• Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment.
• Proven ability to effectively influence, negotiate and manage conflict.
• Strong sense of ownership and pride in quality of outputs.
• Ability to multitask tight timelines prioritizing workload and maintaining high quality standards.
• Flexible attitude with respect to work assignments, new learning opportunities, and ability to thrive in a fast-paced dynamic environment.

#LI-KH1 #LI-Remote

Position Summary:

The Business Development Director - Lab Services is responsible for identifying and closing significant business opportunities for Precision Bioservices in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for all Bioservices products and services, with an emphasis on biobanking, sample preparation services, and specialty lab services
• Develops and enhances client relationships
• Establishes a strong working relationship with Marketing, Technical Support, Customer Support and Production
• Qualifies leads
• Writes proposals, consulting as appropriate with internal Bioservices experts
• Develops project budgets and pricing, utilizing in-house resources to ensure budget accuracy
• Closes new business and expands existing business relationships
• Attend conferences, trade shows and meetings as required
• Maintain contacts and opportunities using SalesForce.com
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree and 5 years of related sales experience; or
• Master’s Degree and 2 years of related sales experience; or
• PhD and 0-1 years of related sales experience

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven track record of successful client relationship management and business development in pharmaceutical, biotech or CRO organization with success in sales of biobanking, sample preparation services, and specialty lab services
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays

Preferred:

• Academic concentration in life sciences or related field
• Masters or Ph.D. in Life Sciences, Molecular Biology or Biochemistry
• 10 years of related sales experience

***Compensation range listed considers base salary with the potential for incentives***

#LI-KH1 #LI-Remote

Position Summary:

The Director, Business Development (Biospecimen Solutions) is responsible for identifying, engaging, developing, and closing significant business opportunities for Precision Biospecimen Solutions in the assigned area of responsibility and/or region.

Essential functions of the job include but are not limited to:

• Identifies opportunities for Biospecimen products and services, with an emphasis on biofluids, prospective collections, tissues, cells and other specialty- and central-lab service offerings
• Builds and maintains relationship and organization map for assigned and identified new Key Clients
• Retain and grow existing account base through the identification of new opportunities and exploring potential cross selling across the Precision Translational Sciences portfolio
• Follow up on all marketing leads and website inquiries to qualify leads
• Prospects for new clients, as appropriate, within the given geographic market to ensure a robust pipeline of opportunities
• Identify potential clients and decision makers within the client organization, perform needs analysis, identify opportunity, and follow up with potential customers
• Ensure that any client complaints are forwarded to the appropriate individual(s) and ultimately resolved in a prompt and professional manner
• Closes new business and expands existing business relationships
• Connects SME’s and other BD’s where added value to client is available
• Establishes a strong working relationship with marketing, clinical operations, lab operations, project management, and other internal stakeholders
• Qualifies & enriches in-bound leads
• Closes business and organically develops future – recurring business
• Attend conferences, trade shows and meetings as required
• Maintain clean customer relationship management metrics in Salesforce.com and other CRM systems
• Other responsibilities as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree in Life Sciences or related field
• 1-2 years of sales experience in Life Science or Healthcare industry OR
• 3+years of Laboratory Research, Service, Clinical Operations, or customer support in Life Science industry

Other Required:

• Team player willing to collaborate and share knowledge
• Ability to work independently, manage time and create plans to achieve personal goal
• Ability to think creatively and strategically and act tactically in a dynamic environment
• Track record of successive increasing levels of responsibility
• Proven command of basic Life Science terminology and application.
• Must be self-directed and self-motivated to work at a highly technical level
• Willing to travel within territory up to 35%
• Must possess a valid driver’s license allowing you to drive in the state(s) you drive in  
• Able to travel both domestically and internationally including overnight stays
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Academic concentration in life sciences or related field
• 5 years of related Life Sciences experience

#LI-KH1 #LI-Remote

Position Summary:
The primary purpose of this position is to manage and optimize the organization’s resources and deliver resource management support to the business. On a day-to-day basis, the Resource Manager II is responsible for executing all staffing processes and activities further defined below.

Essential functions of the job include but are not limited to:
• Perform allocation and assignment of global resources for multiple departments
• Work with stakeholders to understand resource requirements
• Identify and recommends strategies to meet current and future needs
• Identifies capacity constraints and hiring needs for department leaders
• Negotiates and resolves staffing conflicts in collaboration with stakeholders
• Prepare metrics and summary reports on resourcing activities as necessary
• Recommends and influences business operations as it relates to Resource Management 
• Escalate sensitive or high-risk staffing situations to Resource Management leadership and Executive Team as necessary
• Other duties as assigned

Qualifications:
Minimum Required:

• Bachelors degree, or equivalent combination of education and experience
• 3 years resource management experience or equivalent, relevant experience and/or demonstrated competencies

Other Required:
• Proven experience in negotiating with and influencing stakeholders
• Excellent command of spoken and written English
• Demonstrated prior CRO or similar industry experience
• Demonstrated prior Resource Management experience
• Demonstrated ability to work independently and within a team environment 

Competencies:
• Strong interpersonal skills including clear and concise verbal and written communication
• Strong attention to detail
• Ability to solve complex problems using knowledge/skills, precedents and practices
• Ability to exercise independent judgment within broadly defined practices in selecting approaches and methods for obtaining results
• Ability to multi-task and prioritize in a fast-paced environment
• Appropriate financial acumen and understanding of budgets, forecasting, utilization and realization concepts

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.  

Essential functions of the job include but are not limited to:   

• Serve as primary point-of-contact and primary escalation point to the client    
• Coordinate and oversees all functional services including external vendors to the established timeline and budget  
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. 
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities  
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. 
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality 
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.  
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation 
• Establish tracking metrics to monitor trial and team progress towards project goals  
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise  
• Leads both internal and client meetings and set expectations for the project team  
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues 
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency 
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project  
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required 
• Perform other duties as assigned by management  
• Remain compliant with organizational training, time-reporting and any other administrative duties as required 
• Provides on-going feedback, for functional team members including annual performance reviews  

Qualifications:  

Minimum Required:  

• North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience  
• Experience in managing complex and global trials 
• Ability to travel domestically and internationally including overnight stays  

Other Required:  

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS  
• Proven communication and interpersonal skills to effectively interface with others in a team setting  
• Proven organizational skills, attention to detail, and a customer service demeanor  

Competencies:  

• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items 
• Direct work experience in a global, cross-functional project management environment 
• Good understanding of cross-functional management  
• Good understanding of project planning, risk management and change management with an awareness of appropriate escalation 
• Proven experience in strategic planning, risk management and change management  
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective  
• Ability to lead and inspire excellence within a study team  
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency  
• Results oriented, accountable, motivated and flexible  
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills  
• Proven presentation, verbal and written communications skills  
• Good understanding of project management software   
• In depth proven experience in pharmaceutical and/or device research required  
• Preferred: experience with oncology & cell and/or gene therapy

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Position Summary: 

Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordination, and delivery of all activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. 

Essential functions of the job include but are not limited to:  

• Direct, manage and ensure collaboration within a team Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform
• Provide leadership and oversight on all clinical programs and in some unique cases, manage activities 
• Interact with study sponsors as primary point of escalation beyond project management
• Optimize the profitability of the Project Management organization to meet or exceed budget targets
• Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
• Select, train, develop and manage the performance of talent in project leadership positions (Project Directors and Project Managers)
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers
• Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
• Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance
• Understand and manage project/program inter-dependencies to achieve program milestones/deliverables 
• Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
• Measure and report KPIs and lead continuous improvement
• Recognize, exemplify and adhere to Precision’s values that center on our commitment to quality, our people, clients and performance
• Manage workload of supervised staff with continued assessment and adjustment as needed
• Provide on-going feedback, development and coaching of Project Directors and Project Managers including annual performance reviews

Qualifications: 

Minimum Required: 

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
• A minimum 10 years of experience in clinical research, including extensive project management and line management experience or proven competencies for this position
• Working knowledge of GCP/ICH guidelines and the clinical development process

Other Required: 

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project 
• Excellent communication and interpersonal skills to effectively interface with others in a team setting 
• Excellent organizational skills, attention to detail, and a customer service demeanor 
• Ability to travel domestically and internationally including overnight stays 

Preferred: 

• Advanced degree 
• Experience in managing complex and global trials 

Competencies:  

• Working knowledge of project management techniques and tools 
• Direct work experience in a global, cross-functional project management environment 
• Proven experience in people management 
• Proven experience in strategic planning, risk management and change management 
• Ability to work closely with business unit leadership to understand customer's needs 
• Strong analytical skills and business acumen 
• Executive presence with ability to confidently deliver complex presentations to senior management 
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective. 
• Demonstrated leadership track record and effective interpersonal skills 
• Ability to lead and inspire excellence within a team 
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency 
• Results oriented, accountable, motivated and flexible 
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills 
• Excellent presentation, verbal and written communications skills 
• Proficient in project management software  
• In depth proven experience in pharmaceutical and/or device research required 
• Excellent Planning and organizing 
• Excellent at influencing and leading 
• Proven experience in delegating while fostering cohesive team dynamics  
• Demonstrated successful independent negotiation and conflict management strategies
• Preferred experience with Rheumatology and Oncology 

#LI-KH1 #LI-Remote

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.  

Essential functions of the job include but are not limited to:   

• Serve as primary point-of-contact and primary escalation point to the client    
• Coordinate and oversees all functional services including external vendors to the established timeline and budget  
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. 
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities  
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. 
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality 
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.  
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation 
• Establish tracking metrics to monitor trial and team progress towards project goals  
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise  
• Leads both internal and client meetings and set expectations for the project team  
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues 
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency 
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project  
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required 
• Perform other duties as assigned by management  
• Remain compliant with organizational training, time-reporting and any other administrative duties as required 
• Provides on-going feedback, for functional team members including annual performance reviews  

Qualifications:  

Minimum Required:  

• North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred 
• Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience  
• Experience in managing complex and global trials 
• Ability to travel domestically and internationally including overnight stays  

Other Required:  

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS  
• Proven communication and interpersonal skills to effectively interface with others in a team setting  
• Proven organizational skills, attention to detail, and a customer service demeanor  

Competencies:  

• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items 
• Direct work experience in a global, cross-functional project management environment 
• Good understanding of cross-functional management  
• Good understanding of project planning, risk management and change management with an awareness of appropriate escalation 
• Proven experience in strategic planning, risk management and change management  
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective  
• Ability to lead and inspire excellence within a study team  
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency  
• Results oriented, accountable, motivated and flexible  
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills  
• Proven presentation, verbal and written communications skills  
• Good understanding of project management software   
• In depth proven experience in pharmaceutical and/or device research required  
• Preferred: experience with Rheumatology and Oncology 

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Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations.

Essential functions of the job include but are not limited to: 
• Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendorcontracts and site budgets.
• Lead interactions with the North American and European internal study teams, as applicable
• Lead interactions regarding the various agreements with the Site(s)
• Lead interactions regarding assigned agreements with the Sponsor(s)
• Work with supervisor and various internal/external stakeholders to resolve contractual issues.
• Ensure adhered to company policies, procedures, and contracting standards.
• Update relevant study team members and sponsors regarding the status of contract negotiations and execution.
• Coordinate execution of the agreements
• Support the maintenance of contract files and databases, including email and document archiving.
• Other duties as assigned.

Qualifications:

Minimum Required:
• Bachelor’s degree, or equivalent contract management experience preferably in a clinical 
research or similar industry setting

Other Required:
• 3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process.
• Experience in contract research, life science, biotech or pharmaceutical industry is preferred.
• Experience interacting with European institutions.

Preferred:
• Equivalent contract management experience in a clinical research or similar industry setting
• Experience in contract research, life science, biotech or pharmaceutical industry.

Skills:
Competencies 
• Excellent organizational and communication skills and attention to detail
• Experience in tracking status for site contracts and budget, filing and distribution.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan independently or with limited supervision.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments and understanding of the service culture and positive interactions with customers.
• Proficient in MS Office Software programs and computer applications
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.
• Develops, maintains and strengthens relationships with others inside or outside of the organization who can provide information, assistance and support Mentor and/or Ambassador for new Contract and Budget Associates and PFM staff

Job Summary:

Precision is seeking an experienced and passionate regulatory physician to join our team as Vice President, Clinical Development. The Vice President, Clinical Development will have a demonstrated background in Autoimmune. The ideal candidate will have a deep understanding of the US Food and Drug Administration framework, and innovative regulatory strategies to accelerate drug development.

The Vice President, Clinical Development will be responsible for driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for autoimmune conditions. The role will focus on regulatory strategy and clinical development, for early to late phase trials.

Main Duties and Responsibilities:

• Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy.
• Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings.
• Provides strategic drug development consulting to autoimmune, rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights.
• Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications.
• Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed.
• Participate and drive feasibility discussions relating to specific project proposals.
• Develop training modules and conducts training for project teams and colleagues as necessary.
• Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct.
• Propose strategies to manage and accelerate timelines for drug development strategies.
• Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients.

Education and Experience:

Minimum Education and Experience:

• Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other related field, board certification preferred, including European equivalents).
• Experience in direct interactions with US and/or EU Regulatory Authorities
• At least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills, and Competencies:

• Preference will be given to candidates with recent previous health authority experience (current or ex-FDA medical reviewers, etc.) 
• Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, ICF, Breakthrough Designation, and regulatory briefing documents
• Working knowledge of the safety reporting process globally
• The ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance

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