Evaluate Financing Forum: Biotech Strategies for Accessing Capital

You’re invited to a customer-exclusive half-day forum designed for biotech and biopharma innovators, investors, and senior leaders shaping the future of biopharma.

We’ll be bringing together biotech innovators, investors and senior leaders in Pharma for a morning of networking and education, followed by a networking lunch – and we’d love for you to join us.

Discovery Park’s Head of Innovation and Venture Development, Renos Savva, will be speaking on the ‘Pitch to Partnership: What Makes a Biotech Investment Ready?’ panel.

Find out more

Vice President, Internal Medicine Regulatory Strategy

Position: Vice President, Internal Medicine Regulatory Strategy at Pfizer
Location: Discovery Park, Sandwich, Kent 
Role: Full time

 

JOB SUMMARY

Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle.

 

The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes in support of Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia.  The goal of position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products to optimize input to development and commercial decision-making and ultimately lead to approvals with optimal labels for Pfizer’s Internal Medicine portfolio.

 

This includes a track record of successful regulatory achievements in developing and registering drugs or biologics indicated for chronic weight management, obesity or other metabolic- related conditions  a leading and respected voice that has influenced regulatory policy associated with obesity/chronic weight management development,  and evidence of prior role as senior level point person for addressing commercial needs globally for all products and projects in an advanced obesity pipeline.

 

This leader will:

  • Ensure regulatory input is effectively articulated and reflected in clinical development plans to support clear and decisive development and commercial decision-making
  • Gain timely approvals with optimal labels for Pfizer products through use innovative pathways and effective regulatory support for product registration
  • Effectively balance portfolio priorities by dynamically allocating and directing resources to assure qualified regulatory representation and support
  • Ensure compliance of marketed products throughout the product lifecycle and support regulatory product defense activities, as needed
  • Take an active role in regulatory policy priorities by representing Pfizer in appropriate scientific or regulatory activities (e.g., membership in advisory councils and/or trade associations) to influence the regulatory environment as appropriate
  • Partner across GRS to ensure that all regulatory deliverables for submissions and special projects are of high quality and optimally coordinated
  • Serve as key partner for Internal Medicine R&D, U.S. Commercial, and other key functional stakeholder, regularly communicating the regulatory implications of emerging data, and implications of external regulatory environment changes to appropriate stakeholders
  • Champion growth and career development for colleagues in GRS

 

JOB RESPONSIBILITIES

  • Provides regulatory expertise and leadership within the assigned portfolio, and other disease areas as relevant including ensuring global regulatory strategies for all projects and products within the assigned portfolio, as relevant are developed and implemented
  • Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulator’s latest thinking, relevant regulatory approaches and actions; and status of competitor products
  • Partners with leaders in R&D and Commercial teams to develop strong global regulatory strategies for projects and products.
  • Engages in appropriate activities to influence the regulatory environment including developing strong working relationships with regulators, professional bodies, external experts and opinion leaders.
  • Owns resource allocation for GRS IM
  • Champions flexible approaches to ensure efficient and effective resource utilization.
  • May assume responsibility for other activities/functions within GRS as required.
  • Ensures development of all staff functional line help them achieve their full potential.

 

QUALIFICATIONS / SKILLS

  • Advanced Scientific Degree (M.D., Ph.D., PharmD) with a minimum of 10 years’ experience in drug, device, development and/or commercialization.
  • Preferred: 20+ years demonstrable experience in drug and/or device development or relevant experience in the pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs
  • Subject-matter expertise within assigned therapeutic area includes global regulatory strategy experience in the cardiovascular, renal and metabolic disease (CVRM) areas. Has significant experience and track record of achievements in the chronic weight management area and GLP-1 landscape, through prior regulatory experience, and direct product development
  • Proven track record of success in negotiating with global health authorities and in representing interests to external stakeholders
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Proven ability to function autonomously at a senior level in a highly matrixed organization.
  • Proven track record of successful management of staff and complex regulatory, program management or business issues
  • Proven ability to lead with an innovative and agile mindset as well as creatively execute strategic plans.

 

ORGANIZATIONAL RELATIONSHIPS

  • Reports to Head, GRS
  • Member, GRS Leadership Team
  • Member, IM Leadership Team
  • Works with all relevant stakeholders including Chief Internal Medicine Officer, Finance, PX, , Legal, and PGS
  • Works with external contacts including Regulatory Authorities (FDA, EMA, MHLW etc), professional scientific and regulatory groups, trade associations and consultants

 

RESOURCES MANAGED

 

Resources managed is ~15 colleagues

 

Work assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

For more information and to apply

Analytical Scientist

Position:      Analytical Scientist at Viatris

Location:      Discovery Park, Sandwich

Contract:    Full Time

 

Company overview

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Analytical Scientist role will make an impact:

  • Working within our Materials Science team, carry out all analytical activities required to deliver new respiratory products to clinical studies and commercialization
  • Plan and execute experiments to generate scientific understanding in development of analytical methods, formulations and processes.
  • Perform analyses related to clinical supplies, stability, and process scale up.
  • Process data, interpret results and report experimental outcomes to project development team.
  • Troubleshoot instrumentation and investigate aberrant sample results.
  • Maintain laboratory documentation in accordance with cGMP documentation practices.
  • Contribute to project delivery by carrying out other tasks (e.g. laboratory housekeeping, ordering, shipping samples) as required.
  • Adherence to all applicable policies and procedures, including those relating to EHS, GMP, GCP, Quality and Compliance, consistent with the role and any associated responsibilities, including people management where applicable.
  • Perform other duties as assigned consistent with the grade of the role

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  • Relevant Bachelor of Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent, or substantial practical work experience.
  • Good understanding of basic principles of physical, organic and analytical chemistry.
  • Familiar with basic concepts of calculations used in analytical chemistry.
  • Has a good understanding and practical experience of analytical chemistry in product development, including modern laboratory techniques for API, excipient, and drug product testing, e.g., particle sizing, FT-IR, SEM and thermal analysis techniques.
  • Able to work autonomously to deliver individual tasks; able to organise tasks allocated by supervisor and plan own work to consistently achieve output of high quality results in a timely manner.
  • Able to work collaboratively within a team environment.
  • Good understanding of laboratory safety and best practice.
  • Good IT skills (including Microsoft Excel, Word, PowerPoint).
  • Effective verbal and written communication skills.
  • Enthusiasm to work in a laboratory based role.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits At Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

  • Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
  • Focus on career progression with growth and development opportunities
  • Emphasis on Health & Wellness programmes
  • 100% paid medical insurance and Employee Assistance Programme
  • Life cover
  • Excellent employer-matched pension scheme with Viatris contributing up to 11%
  • 2 paid volunteer days per year

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Full job description and to apply: https://www.linkedin.com/jobs/view/4302003767/

 

Scientist for Clinical Trials – Late Stage

Position: Scientist for Clinical Trials – Late Stage at Pfizer
Location: Discovery Park, Sandwich, Kent 
Role: Full time

About the job

The Scientist for Clinical Trials – Late Stage (non-MD, Director) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio. The successful candidate may have managerial responsibility for one or more direct reports and/or contingent worker(s).

 

POSITION SUMMARY

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our Late-Stage Oncology portfolio.

 

KEY RESPONSIBILITIES

  • Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
  • Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
  • Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
  • Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
  • Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
  • In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
  • Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

 

MINIMUM QUALIFICATIONS 

  • PhD/Pharm D OR MS in a relevant Science discipline and strong Clinical Research experience in industry/CRO, OR
  • BA/BS in a relevant Science discipline and extensive Clinical Research experience in a similar role in industry/CRO
  • Clinical Research experience in the phase 2 – 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval
  • Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
  • Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
  • Experience working on large data sets
  • Proficiency with Microsoft Office and relevant scientific software
  • Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
  • Experience leveraging a variety of communication tools and techniques to communicate results
  • Experience solving problems collaboratively and handling conflict constructively
  • Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
  • Experience working proactively and independently, organizing tasks, time and priorities of self and others
  • Experience building partnerships across the company to achieve the needs of the program

 

PREFERRED QUALIFICATION

  • Experience leading a team

 

COMPETENCIES FOR SUCCESS

  • Demonstrates passion for helping patients with cancer and for the science of oncology
  • Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned
  • Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities
  • Promotes team health and exemplifies Pfizer’s leadership behaviours and actionable attitudes
  • Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies
  • Demonstrates foresight and judgment to make complex decisions
  • Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes
  • Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
  • Has a global perspective and mindset.  Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: Hybrid (some office presence is required)

For more information and to apply