210 Parexel jobs in the United Kingdom

Manager, Global Submission Management, Clinical Trials

Uxbridge, London Bristol Myers Squibb

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Purpose**
The Submission Manager, Clinical Trials manages and coordinates the timely, compliant, and accurate delivery of the core submission documents and dossiers to Bristol Myers Squibb (BMS) HA/EC Applicants and CRO. The Submission Manager also participates in the preparation of the CTIS for CT under the EU Regulation
**Key Responsibilities**
+ Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
+ Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
+ Manage the CT Amendment log considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS
+ Provide support to the Submission Senior Manager/collaborate with the Submission Specialist in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
+ Ensure consistency of the Clinical Trial application across projects, studies and countries.
+ Lead Program/Study level CTA Tracking Meetings, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
+ Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
+ Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
+ Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
+ Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
+ Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
+ Coordinate updates within a Program.
+ Support continuous improvement and compliance initiatives
+ Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
+ Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
+ Support implementation of the EU CT REG Portal from Feb 2022.
+ Provide training/mentoring to the GSM-CT newcomers
**Required Qualifications & Experience**
+ BA/BS degree in a science or technology field, preferred
+ Extensive relevant regulatory submissions experience
**Key Competencies**
+ Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
+ Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella.
+ Resolves problems/difficulties with the assistance of senior team members.
+ Supports other functions as appropriate.
+ Independently facilitate compound/study team meetings.
+ Works Independently and collaborates with other functional areas.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident - Employer
A UK Government scheme
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :44:29.952 UTC
**Location:** Uxbridge-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
This advertiser has chosen not to accept applicants from your region.

Senior Clinical Trials Lead (Pharmaceutical - Remote)

B1 1AA Birmingham, West Midlands £75000 Annually WhatJobs

Posted 5 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a prominent pharmaceutical company dedicated to advancing healthcare, is seeking an accomplished Senior Clinical Trials Lead to oversee and manage critical clinical research projects. This role is fully remote, offering the flexibility to work from home anywhere within the UK. You will be responsible for the strategic planning, execution, and successful completion of clinical trials, ensuring adherence to all regulatory requirements, ethical standards, and company protocols. The ideal candidate will possess extensive experience in clinical trial management, with a deep understanding of Good Clinical Practice (GCP), regulatory submissions, and clinical operations. You will have a proven ability to lead cross-functional teams, manage budgets, and mitigate risks associated with clinical trials. Responsibilities include developing clinical trial protocols, selecting and managing clinical sites and investigators, overseeing data collection and monitoring, ensuring timely reporting of trial progress and safety information, and collaborating closely with internal departments (e.g., R&D, regulatory affairs, biostatistics) and external partners. Strong leadership, exceptional organizational skills, and outstanding communication and negotiation abilities are essential. You will play a key role in ensuring the efficient and ethical conduct of studies that contribute to the development of life-changing therapies. This remote position requires a high degree of autonomy, proactivity, and the ability to manage complex projects effectively.

Key Responsibilities:
  • Lead the planning, execution, and completion of clinical trials in accordance with established protocols and regulatory guidelines.
  • Develop and refine clinical trial protocols and associated documents.
  • Oversee the selection, initiation, and monitoring of clinical trial sites and investigators.
  • Manage clinical trial budgets, timelines, and resources effectively.
  • Ensure compliance with GCP, FDA, EMA, and other relevant regulatory requirements.
  • Monitor trial progress, identify potential risks and issues, and implement mitigation strategies.
  • Liaise with internal departments, including R&D, regulatory affairs, and medical affairs.
  • Oversee data management and ensure the integrity and accuracy of clinical trial data.
  • Prepare and present comprehensive clinical trial reports to stakeholders.
  • Contribute to the strategic development of the company's clinical development pipeline.

Qualifications:
  • Bachelor's degree in a life science, nursing, or related field; advanced degree (MSc, PhD) preferred.
  • Minimum of 7-10 years of progressive experience in clinical trial management within the pharmaceutical industry.
  • Demonstrated experience in managing Phase I-IV clinical trials.
  • In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements.
  • Proven leadership and team management skills.
  • Excellent project management, organizational, and problem-solving abilities.
  • Strong communication, negotiation, and interpersonal skills.
  • Experience working effectively in a remote clinical operations environment.
This is a significant opportunity for a seasoned clinical operations professional to drive impactful research and contribute to the development of novel medicines.
This advertiser has chosen not to accept applicants from your region.

Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, E...

Reading, South East IQVIA

Posted 5 days ago

Job Viewed

Tap Again To Close

Job Description

**Join us on our exciting journey!**
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
**Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, EMEA.**
**1 year contract.**
IQVIA's Decentralized Clinical Trials (DCT) enables remote and hybrid clinical studies by connecting patients through digital tools, wearable devices, and virtual visits. It improves accessibility, speeds up recruitment, and ensures compliance across diverse global regulations.
**Responsibilities**
**Client engagement and understanding of client business.**
+ Captures market share by aligning offerings with client needs and regional trends.
+ Maintains and further establishes strong professional relationships across the client organization; with a particular focus on Decentralized Clinical Trials, proactively but appropriately engages with client teams.
+ Responsible for developing and maintaining deep client knowledge; understanding of their business priorities, organizational culture, product portfolio and pipeline, spend/budget priorities.
+ Manages a systematic client-feedback approach, soliciting information from client teams about experience of working with IQVIA.
**Operations management : Leads on the operational management and oversight of IQVIA's DCT activities for local and international markets**
+ Manage assigned strategic and key account relationships individually or in coordination with Global and Regional Sales Teams
+ Identify and respond to customer needs to define potential opportunities for DCT and propose appropriate tailored solutions in line with client needs.
+ Collaborates with IQVIA's Internal RFX, Pricing & Contracts team to support the sales cycle from RFX to sales.
+ Coordinating across clinical operations, technology, and commercial teams to ensure cohesive delivery of DCT solutions.
**Shaping client's perception of IQVIA**
+ Ensures regulatory and operational alignment by tailoring approaches to accommodate Europe's diverse and complex regulatory landscape
+ Identifies opportunities to engage with Client teams to bring relevant marketing and Thought Leadership materials.
+ Manages the annual Strategic Management Review conference.
+ Identifies, or creates opportunities to introduce relevant IQVIANs or teams who are working in areas of high interest for the client, as part of 'peer to peer' engagement (i.e., beyond IQVIA capability presentations, or specific pitches / RFPs)
**Bringing innovation to Client**
+ The Director will champion innovation, integrating emerging technologies and methodologies to differentiate IQVIA services
+ Building on their knowledge of client priorities and in close partnership with the Clinical, Technology Business Partners, and Global Account Director identifies strategic discussions and major opportunities for IQVIA.
+ Actively engages in the Sales and Account Management community, bringing in relevant ideas and success stories from other major accounts.
**Requirements**
+ Extensive knowledge of Decentralized Clinical Trials
+ 10+ years of experience of working in a Sales, Sales engineer, Business development or similar position within the pharmaceutical, CRO, Tech, health, life science or other related regulated industry
+ Proven track record of managing mid-level and high-level contacts
+ Strong organizational, planning, project management skills
+ A developing record of customer contacts at the outsourcing, procurement and mid - management level
+ Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business
+ Excellent analytical skills in assessing and interpreting customer business data
+ Ability to maintain demanding timelines
+ Ability to influence others internally and externally
+ Adaptability and flexibility to changing priorities
+ Demonstrated ability to work creatively in a fast-paced environment
+ Exceptional attention to detail and ability to work simultaneously on multiple priorities
+ Ability to work independently and as a team player
+ Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
+ Excellent oral and written communication skills
+ Ability to establish and maintain effective working relationships with co-workers, managers, and clients
**Why Join?**
Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. In Technology, you will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry.
You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries.
We know that meaningful results require not only the right approach but also **the right people** . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
It's an exciting time to join and reimagine what's possible in healthcare.
**Moving healthcare forward. Together.**
_IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential._
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.

Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, E...

London, London IQVIA

Posted 5 days ago

Job Viewed

Tap Again To Close

Job Description

**Join us on our exciting journey!**
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
**Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, EMEA.**
**1 year contract.**
IQVIA's Decentralized Clinical Trials (DCT) enables remote and hybrid clinical studies by connecting patients through digital tools, wearable devices, and virtual visits. It improves accessibility, speeds up recruitment, and ensures compliance across diverse global regulations.
**Responsibilities**
**Client engagement and understanding of client business.**
+ Captures market share by aligning offerings with client needs and regional trends.
+ Maintains and further establishes strong professional relationships across the client organization; with a particular focus on Decentralized Clinical Trials, proactively but appropriately engages with client teams.
+ Responsible for developing and maintaining deep client knowledge; understanding of their business priorities, organizational culture, product portfolio and pipeline, spend/budget priorities.
+ Manages a systematic client-feedback approach, soliciting information from client teams about experience of working with IQVIA.
**Operations management : Leads on the operational management and oversight of IQVIA's DCT activities for local and international markets**
+ Manage assigned strategic and key account relationships individually or in coordination with Global and Regional Sales Teams
+ Identify and respond to customer needs to define potential opportunities for DCT and propose appropriate tailored solutions in line with client needs.
+ Collaborates with IQVIA's Internal RFX, Pricing & Contracts team to support the sales cycle from RFX to sales.
+ Coordinating across clinical operations, technology, and commercial teams to ensure cohesive delivery of DCT solutions.
**Shaping client's perception of IQVIA**
+ Ensures regulatory and operational alignment by tailoring approaches to accommodate Europe's diverse and complex regulatory landscape
+ Identifies opportunities to engage with Client teams to bring relevant marketing and Thought Leadership materials.
+ Manages the annual Strategic Management Review conference.
+ Identifies, or creates opportunities to introduce relevant IQVIANs or teams who are working in areas of high interest for the client, as part of 'peer to peer' engagement (i.e., beyond IQVIA capability presentations, or specific pitches / RFPs)
**Bringing innovation to Client**
+ The Director will champion innovation, integrating emerging technologies and methodologies to differentiate IQVIA services
+ Building on their knowledge of client priorities and in close partnership with the Clinical, Technology Business Partners, and Global Account Director identifies strategic discussions and major opportunities for IQVIA.
+ Actively engages in the Sales and Account Management community, bringing in relevant ideas and success stories from other major accounts.
**Requirements**
+ Extensive knowledge of Decentralized Clinical Trials
+ 10+ years of experience of working in a Sales, Sales engineer, Business development or similar position within the pharmaceutical, CRO, Tech, health, life science or other related regulated industry
+ Proven track record of managing mid-level and high-level contacts
+ Strong organizational, planning, project management skills
+ A developing record of customer contacts at the outsourcing, procurement and mid - management level
+ Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business
+ Excellent analytical skills in assessing and interpreting customer business data
+ Ability to maintain demanding timelines
+ Ability to influence others internally and externally
+ Adaptability and flexibility to changing priorities
+ Demonstrated ability to work creatively in a fast-paced environment
+ Exceptional attention to detail and ability to work simultaneously on multiple priorities
+ Ability to work independently and as a team player
+ Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
+ Excellent oral and written communication skills
+ Ability to establish and maintain effective working relationships with co-workers, managers, and clients
**Why Join?**
Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. In Technology, you will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry.
You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries.
We know that meaningful results require not only the right approach but also **the right people** . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
It's an exciting time to join and reimagine what's possible in healthcare.
**Moving healthcare forward. Together.**
_IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential._
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.

Senior Formulation Scientist - Drug Development

L3 4AD Liverpool, North West £70000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking an accomplished Senior Formulation Scientist to join their innovative pharmaceutical research and development team based in **Liverpool, Merseyside, UK**. This critical role involves leading the design, development, and optimization of novel drug formulations, from early-stage research through to clinical trial supply. You will be instrumental in translating scientific concepts into viable drug products, addressing complex formulation challenges, and ensuring regulatory compliance. The ideal candidate possesses extensive experience in pharmaceutical formulation, a strong understanding of drug delivery systems, and a proven ability to lead projects and mentor junior scientists.

Key Responsibilities:
  • Lead the formulation development of new drug candidates, including small molecules and biologics.
  • Design and execute experiments to characterize drug substances and excipients.
  • Develop and optimize dosage forms (e.g., oral solids, injectables, topical).
  • Investigate and resolve formulation-related issues encountered during development.
  • Develop and validate analytical methods for formulation characterization.
  • Conduct stability studies and interpret results to define shelf-life.
  • Prepare comprehensive formulation development reports and regulatory submission documents.
  • Collaborate closely with analytical development, DMPK, and manufacturing teams.
  • Stay current with scientific literature, industry trends, and regulatory guidelines.
  • Mentor and guide junior formulation scientists, fostering a culture of scientific excellence.

Qualifications:
  • A Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
  • A minimum of 5-7 years of experience in pharmaceutical formulation development.
  • In-depth knowledge of various dosage forms, drug delivery technologies, and excipient functionalities.
  • Experience with pre-formulation studies, solubility enhancement techniques, and analytical characterization.
  • Proficiency in experimental design and statistical analysis.
  • Strong understanding of regulatory requirements (e.g., ICH guidelines).
  • Excellent problem-solving, organizational, and project management skills.
  • Effective written and verbal communication abilities, with experience presenting to cross-functional teams and stakeholders.
  • Demonstrated leadership potential and experience mentoring team members.

This hybrid role offers a balanced approach to work, combining essential in-lab activities with the flexibility to work remotely. You will be part of a dynamic and collaborative environment at the forefront of pharmaceutical innovation, contributing directly to the development of life-changing medicines. Our client offers a competitive compensation package, excellent benefits, and significant opportunities for professional growth and career advancement within the pharmaceutical industry.
This advertiser has chosen not to accept applicants from your region.

Lead Formulation Scientist, Drug Development

L1 8JQ Liverpool, North West £75000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking an experienced and visionary Lead Formulation Scientist to drive innovation within their Pharmaceutical division in **Liverpool, Merseyside, UK**. This hybrid role combines essential on-site laboratory work with flexible remote responsibilities. You will be instrumental in the design, development, and optimization of novel drug delivery systems and formulations, from early-stage research through to clinical development and commercialization. This position requires a deep understanding of pharmaceutical sciences, material science, and drug product manufacturing processes. You will lead a team of scientists, manage projects, and collaborate with cross-functional teams to advance pipeline assets.

Key Responsibilities:
  • Lead the formulation development of new chemical entities and complex drug products (e.g., injectables, oral solids, biologics).
  • Design and execute experimental studies to evaluate drug solubility, stability, bioavailability, and manufacturability.
  • Develop and optimize formulation strategies to achieve desired therapeutic profiles and patient compliance.
  • Characterize drug product performance using a range of analytical techniques.
  • Oversee technology transfer activities to manufacturing sites and support process validation.
  • Manage project timelines, resources, and budgets, ensuring timely delivery of milestones.
  • Mentor and guide junior formulation scientists, fostering a culture of scientific excellence and innovation.
  • Collaborate closely with preclinical, clinical, regulatory, and manufacturing teams.
  • Author and review technical reports, protocols, and regulatory submission documents.
  • Stay current with industry trends, new technologies, and regulatory guidelines in pharmaceutical formulation.
The ideal candidate will possess a Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Materials Science, or a related discipline, with a minimum of 7 years of relevant industry experience. Demonstrated success in leading formulation development projects and a strong understanding of GMP principles are essential. Expertise in various dosage forms, particularly parenteral and oral drug delivery, is required. Excellent problem-solving, critical thinking, and communication skills are crucial for success in this role. Experience with statistical analysis and design of experiments (DoE) is highly desirable. Join a leading pharmaceutical company in **Liverpool, Merseyside, UK**, and make a significant impact on the future of medicine.
This advertiser has chosen not to accept applicants from your region.

Principal Formulation Scientist - Drug Development

SR1 2AY Sunderland, North East £70000 Annually WhatJobs

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a cutting-edge pharmaceutical research and development company, is seeking a highly experienced Principal Formulation Scientist to join their fully remote R&D team. This senior role is instrumental in driving the innovation and development of novel drug delivery systems and pharmaceutical formulations. You will lead the scientific direction for formulation development projects, from early-stage concept through to pre-clinical and clinical readiness, contributing significantly to the company's pipeline.

Key Responsibilities:
  • Lead the design, development, and optimization of complex pharmaceutical formulations (e.g., oral solid dosage, parenteral, topical) for new chemical entities and existing drug products.
  • Develop and execute comprehensive experimental plans to assess formulation performance, stability, and manufacturability.
  • Provide strategic scientific leadership and technical guidance to a team of formulation scientists and technicians.
  • Troubleshoot formulation challenges and identify innovative solutions to overcome development hurdles.
  • Conduct in-depth literature reviews and stay current with emerging technologies and scientific advancements in pharmaceutics and drug delivery.
  • Prepare and review detailed technical reports, study protocols, and regulatory submission documents (e.g., IND, NDA).
  • Collaborate effectively with cross-functional teams, including analytical development, process chemistry, DMPK, and clinical operations, in a remote setting.
  • Present scientific findings and project updates to internal stakeholders and external partners.
  • Contribute to the intellectual property strategy through patent filings and publications.
  • Ensure all activities are conducted in compliance with GMP, GLP, and other relevant regulatory guidelines.

The ideal candidate will possess a Ph.D. or Master's degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry, or a related discipline, with a minimum of 8 years of progressive experience in pharmaceutical formulation development. A deep understanding of formulation science principles, excipient functionality, and various drug delivery technologies is crucial. Proven experience in leading complex R&D projects and mentoring scientific staff is required. Excellent communication, problem-solving, and organizational skills are essential for success in this remote-first environment. Proficiency in relevant laboratory techniques and analytical methods is expected. This position, though located conceptually near Sunderland, Tyne and Wear, UK , operates entirely remotely.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Parexel Jobs in United Kingdom !

Drug Product Development Scientist

Slough, South East BioTalent

Posted today

Job Viewed

Tap Again To Close

Job Description

contract
Job Title: Drug Product Development Scientist (Injectables) – 12-Month Contract Location: Slough About the Role We are seeking a Drug Product Development Scientist to join a global biopharma partner on a 12-month contract within Pharmaceutical Development Sciences (PDS). You will play a key role in the design, development, and scale-up of sterile injectable drug products — both liquid and lyophilized — from early phase through to late development and BLA approval. Key Responsibilities Establish robust, phase-appropriate manufacturing processes for injectable drug products. Define and optimize process parameters for clinical manufacturing. Partner with internal teams and external CMOs to deliver project objectives. Design and execute lab studies (e.g., filter selection, fill volume assessment, compatibility studies, blinding strategies). Capture and analyze process data to support process characterization and risk assessments. Contribute to preparation of stability and clinical batches, plus PPQ/validation activities. Draft technical protocols, reports, CMC submission sections, and responses to regulatory authorities. Support investigations into deviations, complaints, and knowledge transfer to commercial scale. Drive continuous improvement in departmental ways of working. Candidate Profile Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related field. 2–3 years’ experience in liquid drug product development and/or manufacturing within pharma. Knowledge of aseptic manufacturing for sterile products (vials, cartridges, pre-filled syringes) strongly preferred. Experience with sterile DP components, process transfer, scale-up, and optimization advantageous. Strong skills in data analysis, technical writing, and cross-functional collaboration. What’s on Offer 12-month contract with the opportunity to contribute to cutting-edge biopharma development. Involvement across early-to-late stage DP development and regulatory submission activities. Collaborative and dynamic environment with international exposure.
This advertiser has chosen not to accept applicants from your region.

Drug Product Development Scientist

Slough, South East BioTalent

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Job Title: Drug Product Development Scientist (Injectables) – 12-Month Contract

Location: Slough


About the Role

We are seeking a Drug Product Development Scientist to join a global biopharma partner on a 12-month contract within Pharmaceutical Development Sciences (PDS). You will play a key role in the design, development, and scale-up of sterile injectable drug products — both liquid and lyophilized — from early phase through to late development and BLA approval.


Key Responsibilities

  • Establish robust, phase-appropriate manufacturing processes for injectable drug products.
  • Define and optimize process parameters for clinical manufacturing.
  • Partner with internal teams and external CMOs to deliver project objectives.
  • Design and execute lab studies (e.g., filter selection, fill volume assessment, compatibility studies, blinding strategies).
  • Capture and analyze process data to support process characterization and risk assessments.
  • Contribute to preparation of stability and clinical batches, plus PPQ/validation activities.
  • Draft technical protocols, reports, CMC submission sections, and responses to regulatory authorities.
  • Support investigations into deviations, complaints, and knowledge transfer to commercial scale.
  • Drive continuous improvement in departmental ways of working.


Candidate Profile

  • Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related field.
  • 2–3+ years’ experience in liquid drug product development and/or manufacturing within pharma.
  • Knowledge of aseptic manufacturing for sterile products (vials, cartridges, pre-filled syringes) strongly preferred.
  • Experience with sterile DP components, process transfer, scale-up, and optimization advantageous.
  • Strong skills in data analysis, technical writing, and cross-functional collaboration.


What’s on Offer

  • 12-month contract with the opportunity to contribute to cutting-edge biopharma development.
  • Involvement across early-to-late stage DP development and regulatory submission activities.
  • Collaborative and dynamic environment with international exposure.
This advertiser has chosen not to accept applicants from your region.

Principal Scientist - Drug Discovery & Development

S1 4DA Sheffield, Yorkshire and the Humber £80000 Annually WhatJobs

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a leading pharmaceutical research organization, is seeking a highly accomplished Principal Scientist to drive innovation in their drug discovery and development pipeline. This critical role is based at our state-of-the-art facility and focuses on identifying, validating, and advancing novel therapeutic targets. You will lead a team of talented researchers, overseeing projects from initial concept through to preclinical development. The ideal candidate will possess extensive expertise in molecular biology, pharmacology, or a related life science discipline, with a proven track record of success in pharmaceutical research. Responsibilities include designing and executing complex experimental studies, interpreting data, contributing to strategic decision-making, and publishing findings in high-impact journals. Strong leadership qualities, excellent problem-solving skills, and the ability to foster a collaborative and innovative research environment are essential. This is a hands-on role requiring significant laboratory work and direct contribution to groundbreaking scientific advancements.

Responsibilities:
  • Lead and manage research projects focused on the discovery and development of novel therapeutics.
  • Design and execute complex experiments using advanced techniques in molecular biology, cell biology, and/or pharmacology.
  • Develop and validate new assays and experimental models for target identification and validation.
  • Analyze and interpret experimental data, drawing robust conclusions and making strategic recommendations.
  • Oversee the work of junior scientists and research associates, providing mentorship and guidance.
  • Collaborate effectively with cross-functional teams, including chemistry, DMPK, and clinical development.
  • Contribute to the company's intellectual property strategy through invention disclosures and patent filings.
  • Prepare and present research findings at internal reviews, scientific conferences, and potentially in peer-reviewed publications.
  • Ensure compliance with all relevant safety, ethical, and regulatory guidelines.
  • Contribute to the strategic direction of the R&D department and identify new areas for scientific exploration.
Qualifications:
  • Ph.D. in Molecular Biology, Pharmacology, Biochemistry, or a closely related life science field.
  • Minimum of 8 years of post-doctoral research experience in the pharmaceutical or biotechnology industry.
  • Demonstrated success in leading research projects and delivering on drug discovery milestones.
  • Expertise in relevant therapeutic areas (e.g., oncology, immunology, neuroscience) is highly desirable.
  • Proficiency in a broad range of experimental techniques and state-of-the-art technologies.
  • Strong understanding of drug discovery and development processes.
  • Excellent leadership, team management, and interpersonal skills.
  • Exceptional analytical, critical thinking, and problem-solving abilities.
  • Outstanding written and verbal communication skills, with a strong publication record.
  • Ability to work collaboratively in a fast-paced, team-oriented environment.
This is an on-site position located in Sheffield, South Yorkshire, UK , offering the opportunity to work within a leading research facility.
This advertiser has chosen not to accept applicants from your region.
 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Parexel Jobs