Clinical Research Manager

Solvemed is currently recruiting a senior science lead, with substantial experience leading: 

• industrial R&D groups, especially in the context of external innovation (dealing with early-stage start-ups), and/or  
• early-stage research-based companies, especially where R&D translated into value for industrials. 

- Experience in neuroscience and/or biomarkers and/or digital tools mandatory 

- Entrepreneurial, proactive, can-do attitude mandatory

- Experience in growing, leading and managing teams mandatory

- Experience in clinical research and/or medical device (co-)development programmes welcome 

- Experience in developing, securing and managing research and development grants applications and projects is necessary

- Experience in building and growing relevant external networks across diverse stakeholders welcome

The overall objective of the role is to: 

• Take the overall responsibility for company’s R&D strategy and execution to support company’s work with partners and clients across academia, industry and healthcare providers 
• Generate scientific validation evidence required for establishing research and development projects, commercial agreements, product implementation, and regulatory submissions 
• Support product development and validation efforts through strategic research work with both academia and industry

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• Set strategic research goals and strategy in biomarker validation and product development, in close collaboration with the company management, taking into account the necessary research regulations/frameworks and clinical/validation evidence requirements 
• Engage and coordinate external research and/or commercial partners, as necessary, for the purpose of planning, management and execution of research and development work 
• Understand and develop company value proposition for prospective research and co-development parties, which may include academia, industry, healthcare providers 
• Engage industrial and clinical KOLs to help establish and grow company’s advisory board 

• Project management and administration of research activities across all stakeholders including partners, CROs, trial site(s) and in-house team 
• Screening, qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical studies, as necessary 
• Helping establish contacts with the national international academic and industrial research community, including external research networks and funding councils, building relationships to increase collaborative working opportunities in research settings
• Developing SOPs and work instructions to ensure internal files and clinical trial/study files conform to Good Clinical Practice regulations and standards 
• Developing and collating all study related documents including Clinical Investigation Protocol, Patient Information, Investigator Brochure, Competent Authority and Ethics Committee submissions. 

• Ensure adherence to protocols and compliance with regulatory (ICH/GDP) guidelines and SOPs 
• Developing effective relationships and rapport with colleagues and clinical research partners as well as the relevant regulatory authorities such as the FDA, EMA and MHRA 
• Ensuring effective translation of insights and feedback from clinical and pre-clinical work to relevant internal teams 
• Ensuring all research studies are documented clearly and concisely for regulatory submissions and publications 
• Monitoring and reporting of study progress in co-ordination with CROs, where relevant 

• Lead the design of research protocols (including clinical study protocols), involving retrospective and/or prospective patient data 
• Taking overall responsibility for research data analysis and report writing, including leading data science team as necessary 
• Coordinate internal work necessary for successful delivery of research and development work objectives – this includes managing and growing own team and working closely with the Heads of other company divisions 
• Support strategic product implementation across healthcare providers for research and commercial purposes 
• Work closely and communicate openly with colleagues in product development, data science, regulatory, and commercial teams for maximum organisational alignment and work effectiveness

• Work directly with internal data scientists and ML engineering, assuming overall responsibility for the strategic direction of research data analysis and internal and external study results reporting
• Where needed and appropriate, take hands-on leadership on research data statistical analytics  
• Manage own budget, in accordance with company’s cash flows and capital needs 
• Actively grow their team and pro-actively help with recruitment
• Set R&D funding strategy and lead sourcing of necessary non-dilutive R&D funding (e.g. research grants) to support the research and development strategy execution

• Scrutinise and critique research and enterprise grant applications of major strategic and financial importance to the organisation, advising and coaching staff on improvements leading to increased success rates.
• Where necessary, take hands-on leadership over the research grant writing process. 
• Actively represent the organisation and especially its research and development efforts at appropriate committees (e.g., related to grant applications), conferences, and other, depending on the strategic needs of the company

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• At least 6 years of research leadership experience in a life science start-up and/or industrial context (PhD research not included)
• Demonstrable track record of relevant world-class research, including strong scientific public record, preferably at the clinical stage and in neuroscience and/or biomarkers and/or medical devices 
• Strong network of relevant potential service providers, KOLs/advisors, potential collaborators, research partners 
• Strong experience in clinical study design and execution, including in clinical protocol design, study planning and management experience, statistical analysis planning 
• Good analytical abilities, practical knowledge of statistical methods, preferably practical understanding of machine learning driven approaches 
• Preferably, experience in working in small-medium sized medical technology companies, especially on point-of-care technologies in proof-of-concept development stages 
• Preferably, demonstrable entrepreneurship experience, especially in building own venture in life sciences and/or collaborative project design 
• Experience in applying for internationally competitive research grants 
• Preferably, experience managing budgets in research and development context 
• PhD and or MD from a strong university 
• Preferred specialization in neurosciences, neuro-ophthalmology, ophthalmology, biomarkers 

• Shows can-do attitude, resourceful, proactive and energetic 
• Dedicated to the cause and company mission and values
• Organised and diligent 
• Systematic and analytical 
• Highly organised and able to prioritise workload. 

• Leader and team player 
• Adaptable and flexible within a team environment 
• Great communicator, in speech and in writing (English language) 

• Shows can-do attitude, resourceful, proactive and energetic 
• Dedicated to the cause and company mission and values
• Organised and diligent 
• Systematic and analytical 
• Highly organised and able to prioritise workload. 

• Leader and team player 
• Adaptable and flexible within a team environment 
• Great communicator, in speech and in writing (English language) 

• High level of autonomy and leadership opportunities 
• Working (hard) on world-changing technology with leaders in the field 

• Opportunity to solve some of the biggest problems in neurology and drug development 
• Dynamic, innovative, passionate, entrepreneurial, international team 
• Inclusive company culture 
• Flexible hours (work possible outside of typical hours)

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• High level of autonomy and leadership opportunities 
• Working (hard) on world-changing technology with leaders in the field 

• Opportunity to solve some of the biggest problems in neurology and drug development 
• Dynamic, innovative, passionate, entrepreneurial, international team 
• Inclusive company culture 
• Flexible hours (work possible outside of typical hours)

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