Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

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

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

#LI-OS1 #LI-Remote

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

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

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site 
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form. 
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English. 

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. 
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

#LI-OS1 #LI-Remote

Due to our continued growth, Precision for Medicine is looking for a Senior Feasibility Associate/Feasibility Manager to join our European team. This position can be covered fully remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

The Senior Feasibility Associate/Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate/Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Senior Feasibility Associate/Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Senior Feasibility Associate/Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

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

Support pre-award feasibility projects

• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.

Provide support to post-award feasibility projects

• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred:
• Postgraduate degree preferred.

Skills

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies
• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail with ability to see the big picture
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

#LI-TB1

#LI-Remote

Due to our continued growth, Precision for Medicine is looking for a Senior Feasibility Associate/Feasibility Manager to join our European team. This position can be covered fully remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary:

The Senior Feasibility Associate/Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate/Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Senior Feasibility Associate/Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Senior Feasibility Associate/Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

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

Support pre-award feasibility projects

• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.

Provide support to post-award feasibility projects

• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)

Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred:
• Postgraduate degree preferred.

Skills

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies
• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail with ability to see the big picture
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

#LI-TB1

#LI-Remote

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 3500 dedicated professionals and offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

We are seeking an accomplished Senior Marketing Manager to drive strategic marketing initiatives that support our expanding Autoimmune therapeutic area business (both full-service outsourcing [FSO] and Functional Service Provider [FSP] models), and our core CRO portfolio. This role requires a highly autonomous leader with strong cross‑functional collaboration skills and the ability to translate global strategy into high‑impact execution.

In this position, you will shape and refine service messaging, design and deliver integrated marketing campaigns, generate qualified leads, and empower a growing sales team in achieving their targets. You will work closely with sales and operational stakeholders to elevate market awareness, strengthen our value proposition, and accelerate lead generation across key service lines.

• Service Marketing & Content Development
  • Lead and own strategic planning of marketing efforts for assigned areas, specifically all therapeutic marketing for our growing Autoimmune therapeutic area, clinical FSP, and related services. Support other services within our CRO offerings as assigned
  • Create messaging frameworks relating Feature/Advantage/Benefit (FAB) with proof points to optimize market positioning
  • Work with stakeholders (and agencies as needed) to create compelling, differentiated messaging based on the FAB analysis to drive product awareness and engagement with clients
  • Develop content strategies to leverage the messaging, considering omnichannel approaches
  • Drive the development, implementation, and optimization of sales enablement tools to activate the sales force in attainment of financial targets
  • Identify Autoimmune and FSP client profiles in cooperation with Lead Generation and Inside Sales Team

• Digital Marketing & Social Media
  • Develop and execute a digital content strategy, leveraging an omni-channel approach including blogs, website, SEM, SEO, AI search, social media, and other channels.
  • Ensure consistent messaging and engagement with key stakeholders across digital platforms.
  • Monitor impact of digital strategy to prioritize highest ROI activities
    
    
• Thought Leadership & Stakeholder Engagement

• Collaborate with operational, medical/scientific and commercial teams to identify relevant topics and ensure high-quality content delivery.
• Incorporate a thought leadership strategy demonstrating Precision’s focused approach to autoimmune, oncology, rare indications, and other areas identified by commercial strategy, using video, white papers, and other channels to maximize exposure
• Proactively, work with stakeholders across Precision businesses to foster convergence and holistic storytelling

• Event Management
  • Lead cross-functional planning and execution of a yearly conference strategy for assigned areas including budgeting, messaging, and execution in partnership with the PFM event team.
  • Attend select events in person

• Leadership & Strategic Contribution
  • Provide expertise and guidance to team members and cross-functional partners.
  • Lead and manage complex projects or functional areas, ensuring alignment with business goals.
  • Actively contribute to the development of departmental strategies and marketing plans.
  • Continuously improve technical skills and stay current with emerging technologies and marketing trends.
  • Ensure projects are delivered on time and within budget across the entire project lifecycle.
  • Provide competitive intelligence input to drive growth strategies.
  • Mentor junior team members and contribute to talent development across the marketing function
  • Serve as a strategic advisor to senior leadership on marketing initiatives and business impact
  •  
• Reporting:
  • Monthly reporting on all activities relevant to assigned business areas, conference planning and updates, podcasts, webinars and other key activities. 
  • Deliver actionable insights and strategic recommendations based on performance metrics, market trends, and stakeholder feedback

Minimum Education & Experience:

• Bachelor’s degree in a related field and a minimum of 12 years of relevant work experience in Marketing, Communications, Life Sciences, biotech, or healthcare sectors; advanced degree plus a minimum of 4 years of relevant work experience a plus.
• 6–8 years of experience in a marketing role with a proven track record of independently leading projects, including customer-facing initiatives. Demonstrated experience in therapeutic area marketing and FSP services; specific experience in Autoimmune and familiarity with broader clinical CRO services is a strong plus.Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
• Proven success in developing webinars and live events, including speaker coordination and promotional strategy.
• Exceptional analytical and problem-solving skills, with the ability to communicate complex information clearly and effectively.
• Proficiency in project management tools and methodologies, including scheduling, budgeting, and status reporting.
• Strong leadership and organizational skills, with a track record of effective stakeholder engagement.
• Ability to identify and present data-driven insights that influence strategic decision-making.
• Skilled in building and maintaining strong customer relationships through active listening and thoughtful inquiry.
• Solid understanding of end-to-end work processes, with the ability to assess and optimize for efficiency and effectiveness.
• Follows Company's Principle and code of ethics on a day-to-day basis.
• Shows appreciation for individual talents, differences, and abilities of fellow team members.
• Listens and responds with appropriate actions.
• Leads change initiatives and continuous process improvements.

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 3500 dedicated professionals and offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

We are seeking an accomplished Senior Marketing Manager to drive strategic marketing initiatives that support our expanding Autoimmune therapeutic area business (both full-service outsourcing [FSO] and Functional Service Provider [FSP] models), and our core CRO portfolio. This role requires a highly autonomous leader with strong cross‑functional collaboration skills and the ability to translate global strategy into high‑impact execution.

In this position, you will shape and refine service messaging, design and deliver integrated marketing campaigns, generate qualified leads, and empower a growing sales team in achieving their targets. You will work closely with sales and operational stakeholders to elevate market awareness, strengthen our value proposition, and accelerate lead generation across key service lines.

• Service Marketing & Content Development
  • Lead and own strategic planning of marketing efforts for assigned areas, specifically all therapeutic marketing for our growing Autoimmune therapeutic area, clinical FSP, and related services. Support other services within our CRO offerings as assigned
  • Create messaging frameworks relating Feature/Advantage/Benefit (FAB) with proof points to optimize market positioning
  • Work with stakeholders (and agencies as needed) to create compelling, differentiated messaging based on the FAB analysis to drive product awareness and engagement with clients
  • Develop content strategies to leverage the messaging, considering omnichannel approaches
  • Drive the development, implementation, and optimization of sales enablement tools to activate the sales force in attainment of financial targets
  • Identify Autoimmune and FSP client profiles in cooperation with Lead Generation and Inside Sales Team

• Digital Marketing & Social Media
  • Develop and execute a digital content strategy, leveraging an omni-channel approach including blogs, website, SEM, SEO, AI search, social media, and other channels.
  • Ensure consistent messaging and engagement with key stakeholders across digital platforms.
  • Monitor impact of digital strategy to prioritize highest ROI activities
    
    
• Thought Leadership & Stakeholder Engagement

• Collaborate with operational, medical/scientific and commercial teams to identify relevant topics and ensure high-quality content delivery.
• Incorporate a thought leadership strategy demonstrating Precision’s focused approach to autoimmune, oncology, rare indications, and other areas identified by commercial strategy, using video, white papers, and other channels to maximize exposure
• Proactively, work with stakeholders across Precision businesses to foster convergence and holistic storytelling

• Event Management
  • Lead cross-functional planning and execution of a yearly conference strategy for assigned areas including budgeting, messaging, and execution in partnership with the PFM event team.
  • Attend select events in person

• Leadership & Strategic Contribution
  • Provide expertise and guidance to team members and cross-functional partners.
  • Lead and manage complex projects or functional areas, ensuring alignment with business goals.
  • Actively contribute to the development of departmental strategies and marketing plans.
  • Continuously improve technical skills and stay current with emerging technologies and marketing trends.
  • Ensure projects are delivered on time and within budget across the entire project lifecycle.
  • Provide competitive intelligence input to drive growth strategies.
  • Mentor junior team members and contribute to talent development across the marketing function
  • Serve as a strategic advisor to senior leadership on marketing initiatives and business impact
  •  
• Reporting:
  • Monthly reporting on all activities relevant to assigned business areas, conference planning and updates, podcasts, webinars and other key activities. 
  • Deliver actionable insights and strategic recommendations based on performance metrics, market trends, and stakeholder feedback

Minimum Education & Experience:

• Bachelor’s degree in a related field and a minimum of 12 years of relevant work experience in Marketing, Communications, Life Sciences, biotech, or healthcare sectors; advanced degree plus a minimum of 4 years of relevant work experience a plus.
• 6–8 years of experience in a marketing role with a proven track record of independently leading projects, including customer-facing initiatives. Demonstrated experience in therapeutic area marketing and FSP services; specific experience in Autoimmune and familiarity with broader clinical CRO services is a strong plus. Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
• Proven success in developing webinars and live events, including speaker coordination and promotional strategy.
• Exceptional analytical and problem-solving skills, with the ability to communicate complex information clearly and effectively.
• Proficiency in project management tools and methodologies, including scheduling, budgeting, and status reporting.
• Strong leadership and organizational skills, with a track record of effective stakeholder engagement.
• Ability to identify and present data-driven insights that influence strategic decision-making.
• Skilled in building and maintaining strong customer relationships through active listening and thoughtful inquiry.
• Solid understanding of end-to-end work processes, with the ability to assess and optimize for efficiency and effectiveness.
• Follows Company's Principle and code of ethics on a day-to-day basis.
• Shows appreciation for individual talents, differences, and abilities of fellow team members.
• Listens and responds with appropriate actions.
• Leads change initiatives and continuous process improvements.

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.