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Regulatory Affairs, Senior Director
Permanent / Berkshire, England
Job title: Regulatory Affairs Senior Director A global pharmaceutical company with products in Neurology, Oncology and Rare Diseases are seeking a Regulatory Affairs Senior Director to join their team. This is a UK and Ireland affiliate role, leading several cross functional teams. This position will sit on the Affiliate leadership team and report directly into the UK and Ireland General Manager. Responsibilities: Leading strategy, tactics and implementation of all regulatory aspects for assigned products Ensure regional regulatory specificities and needs are incorporated into the global plans through collaboration with local and intercontinental Regulatory Affairs where available. Provide guidance to the team of experts to ensure full compliance of local & global regulations applicable to the UK & Ireland affiliate Ensure that the UK and Ireland Affiliate has a compliant and comprehensive pharmacovigilance and complaint system in place. Provide regulatory input into the integrated development plan. In collaboration with other research & development departments, define the optimal plan to reach the target product profile Requirements: Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs Proven ability to influence leaders helping them to understand a highly regulated environment. Proven ability to lead cross functional teams. Extensive experience in UK/IE markets would be desirable. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer To apply for this position or hear further details then please contact Freddie Hill at Freddie.hill@pharma-partners.co.uk
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Regional Medical Director - Rare Diseases
Permanent / Buckinghamshire, England
Job title: Regional Medical Director - Rare Diseases A global rare disease biotech are looking for a Regional Medical Lead to work on their leading marketed product. You will lead on regional strategy, matrix manage affiliate medical teams and work closely with key cross functional groups to ensure the deliver of medical activities. This role is a key member of the medical affairs leadership team and is a highly visible position within the growing organisation. Responsibilities: Act as a subject matter expert to the International Region Responsible for the development and execution of the medical activities within the International Medical Plan, and supporting in country medical activities when needed Responsible for ensuring the medical activities are aligned to the Global Medical Strategy for the disease area and product(s) Develop and lead International scientific educational programs and events for Healthcare providers in partnership with cross functional teams Develop and lead International scientific advice seeking events Establish networks with external experts to expand potential research opportunities aligned with the Global Medical Strategy and Key Areas of Interest, and seek medical insights to inform local and regional strategy Support Global Medical Operations and Country Medical Teams to deliver data generation activities including investigator-initiated research and company sponsored phase IV and or non-interventional research. Line manage 1 direct report and matrix manage regional affiliate leaders Requirements: MD or MPharm degree preferred Extensive experience in medical affairs at both affiliate and regional level required ABPI final signatory preferred Prior experience in rare diseases or a biotech environment would be advantageous Salary and benefits: A highly competitive salary and wider benefits scheme is on offer
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Senior Director Clinical Development - Infectious Diseases
Permanent / Pennsylvania, USA
Senior Medical Director, Clinical Development - Infectious Diseases As the Senior Clinical Development Director, you will drive late-stage activities for a monoclonal antibody treatment of COVID-19. This is a very fast paced environment and will present you with the chance to make a real impact to patients during the pandemic. Reporting into the VP Clinical Research this Senior Medical Director role will have a specific focus on leading the downstream Clinical and Medical Affairs interactions. You'll be required to develop and drive the integrated clinical development plan, provide medical leadership to cross functional projects, and play a key part in regulatory interactions. Where appropriate this position can offer direct line management responsibility in addition to providing medical and scientific leadership in a matrix environment. Responsibilities: Provide expert leadership of disease area specific strategy for programs Develop and manage the clinical development plan for assigned asset(s) Act as a medical and scientific expert for cross functional projects Generate the data and evidence required to determine a medicine's potential efficacy Provide scientific and clinical support for regulatory submissions Engage and interact with a diverse range of external scientific experts in order to align and deliver the integrated clinical development strategy Accountable for benefit/risk of the asset(s) Provide leadership across a matrix environment Line manage as appropriate Candidate requirements: MD or PhD Extensive Infectious Diseases experience in Clinical Drug Development Understanding of clinical development strategy and planning Demonstrable experience in managing stakeholders Thorough understanding of clinical research methodology and biostatistics Ability to effectively interpret and communicate clinical data To apply for this position please use the "Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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Global Regulatory Affairs Associate Director - Diagnostics
Permanent / Berkshire, England
Job title: Global Regulatory Affairs Associate Director - Diagnostics, IVDR This role reports to the Head of Diagnostics Regulatory, Global Regulatory Affairs. The purpose of the Associate Director of Diagnostics Regulatory role is to provide international strategic, tactical, and operational strategies for Diagnostics to enable early-stage, late-stage and marketed compounds by supporting international clinical trials, market registration submissions, and post-approval submissions. Responsibilities: Serves as the primary international regulatory subject matter expert in IVD development Develops and executes the international diagnostics regulatory strategy, including global diagnostic and molecule strategies. Provides high quality, timely and decisive regulatory advice to allow diagnostic development and therapeutic teams to make well-informed decisions on diagnostics development or product life cycle planning. Determines and communicates international submission and approval requirements and regulator expectations for the use of IVDs in clinical trials or registration of IVDs, including companion diagnostics. Act as a subject matter expert on IVDR (In Vitro Diagnostic Regulation) within the team and the broader business. Requirements: At least a BSc in a related life/health science subject. Advanced degrees (MS, JD, PharmD, PhD) in health/life science would be preferred. At least five (5) years' experience in international diagnostics regulatory affairs (authority or industry) including extensive experience in a research-based diagnostics Knowledge of ICH and local regulatory authority regulations regarding therapeutic trials Demonstrate a deep understanding and knowledge of European Diagnostics regulations and procedures additional understanding of Japanese and/or Chinese diagnostic/companion devices regulations. Possess solid industry-related experience in the co-development of Diagnostics with therapeutic products. Extensive experience in a research-based diagnostics development role with strong regulatory affairs exposure. Salary and benefits: A highly competitive salary, annual bonus, car allowance and private medical insurance is on offer To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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Director - RWE Strategy & Partnerships (Global Med Affairs)
Permanent / Massachusetts, USA
Director - RWE Strategy & Partnerships (Global Medical Affairs) As part of the Global Medical Affairs group, this position reports into the VP & Head of Data Insights/Generation and sits alongside counterparts for Epidemiology and Biostatistics. This position is responsible for collaborating with different business functions to align product RWE strategy as part of an integrated evidence generation plan. You will need to develop RWE programs that resolve any evidence gaps across the portfolio/pipeline. You will need to develop and maintain strong external partnerships to utilise existing and emerging sources of Real World Data, and identify new technologies and opportunities to advance the businesses evidence generating capabilities. Key responsibilities: Design and implement a strategic RWE framework Develop RWE programs to bridge evidence gaps Identify opportunities to partner with key external data sources Seek out and attend relevant conferences and events Create therapy area specific RWE plans Design, implement, and oversee all RWE programs Collaborate cross functionally with key internal stakeholders on RWE projects Ensure global alignment of Medical Affairs studies Devise and implement an RWE framework Candidate Requirements: Scientific qualification, ideally to post-graduate degree level (eg. MSc, PhD, MD, MPharm) Demonstrable experience in RWE (must be from Pharma and not solely agency) Experience of working in Medical Affairs Ability to develop and maintain key internal and external relationships Curiosity and passion for advancing technologies and science Excellent communication skills Salary & Remuneration: Annual salary depending on location and experience plus a benefits package to include car allowance and annual bonus To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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