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Medical Director – Clinical Development Haematology

Ref: JR-34276

Location: London, UK

Type: Contract

EXCITING CONTRACT OPPORTUNITIES FOR PHYSICIANS I would like to speak to Physicians open to contract work in the Rare Disease arena.

Does a start up culture excite you?

This dynamic, fast paced start up is looking for a medic with Board Certification/Specialisation in Haematology (pref but not essential) who has worked extensively in Drug Discovery and Clinical Development. Experience in gene or cell therapy is an advantage.

As Medical Director in Clinical Development, you would be responsible for creating and delivering the global medical strategy and assisting into global regulatory activities.

The applicant needs to have a strong record of delivering and developing new drugs, scientific accomplishment and cross-functional collaboration.

Strategic planning, board level communication, scientific community engagement on a global basis is all part of daily activity.

VARIOUS ROLES IN MEDICAL MONITORING

LONGTERM CONTRACTS

DYNAMIC START UP CULTURE, FAST PACED

IDEALLY EXPERIENCE IN LSD OR HAEMATOLOGY OTHERWISE SOUND TRACK RECORD IN MEDICAL MONITORING.

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Director GCP Quality Assurance

Ref: CW-43285

Location: Boston MA

Type: Permanent

We have partnered with an exciting, small biotech sponsor company dedicated to the development and commercialization of novel therapeutics to treat patients suffering from rare inherited genetic blood disorders. Sickle cell disease and beta-thalassemia have limited treatment options and are both characterized by severe symptoms and effects and reduced life expectancy. Our client is driven by their patient-centric mission of delivering these therapeutics and enhancing quality of life for this underserved patient population.

The role: 

We are seeking an exceptional individual who is a self starter, excited by the opportunity to be part of building a quality culture from the ground up and serving as internal SME for clinical quality. Reporting to the Vice President of Quality Assurance, the the successful candidate for the Director GCP Quality Assurance position will be primarily responsible for the following:

• Develop GCP compliance strategy for internal and external partners
• Provide GCP Quality guidance for all clinical development programs
• Develop, implement and maintain relevant quality management system to ensure compliance with applicable national and international regulations and standards
• Develop and execute the audit strategy for compliance audits in accordance with both US and international guidelines including clinical investigator sites, contract clinical laboratories, CROs and internal operations
• Manage Quality Assurance reviews of clinical and nonclinical study documents and regulatory submissions
• Build and manage a small team of employees and external resources to achieve Quality goals and objectives
• Manage inspection readiness activities and provide support for audits and regulatory authority inspections for internal stakeholders and external service providers

The qualifications: 

• Bachelor degree in a life science discipline, higher degree preferred
• 15+ years experience in positions of increasing responsibility within a biopharma
• Hands on experience planning, conducting and overseeing GCP audits
• Experience reviewing and auditing study related documents including nonclinical and clinical study reports, investigator’s brochures, clinical study protocols, trial master files
• Solid understanding of domestic and international GLP regulations
• Experience working within a small biotech environment preferred
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members

Other:

This is a full-time, 40 hour per week permanent leadership position based in an office setting with up to 25% travel requirement to external partner organizations. Due to the current COVID-19 crisis, our client has agreed to complete the interview and onboarding process for this position remotely. The successful candidate will perform the duties of this position remotely until it becomes safe to travel, at which time this position will be a fully office-based position. 

Our client is deeply committed to workplace diversity and inclusion and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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Executive Director of Business Development-Leadership Role

Ref: DB-0635

Location: Boston, North Carolina, Tennessee & San Francisco

Type: Permanent

I am working exclusively with a global CRO who provide a comprehensive range of services in clinical development. With expertise spanning all the major therapeutic areas and a customer-centric focus of a creative, forward thinking organisation.

My client is looking for a business developer who has experience leading a team and a proven track record of improving sales growth, within a full service CRO. This person will have to be able to effectively manage the workload and teams associated with securing new business in the small to midsize biotech and Pharma.

Responsibilities:

• Supervise and train Business Development team, advises on prospecting and closing new projects

• Oversight/management of annual marketing events at industry conferences (venue, invitations, attendee coordination, giveaways, etc.)

• Monitor monthly, quarterly, and annual sales, by representative and by client

• Serve as primary Business Development Representative and perform all associated duties as resourcing requires

• Interact with clients as needed to explain operational strategy and related budgeting approaches; and conduct pricing negotiations

• Participate in weekly and monthly Department Head Meetings and Project Review

• Coordinate, develop content for, and run monthly global partner meetings. Review and approval of meeting minutes

• Manages and mentors the sales team to maintain the highest level of professionalism and responsiveness during the entire process

• Responsible for development and management of annual marketing budget

• Provides leadership and task-related supervision to the BD and administrative teams

Experience / Education

• 10+ years in Business Development within the life sciences industry (CRO/Pharma/Biotech) required; Marketing and Proposal experience required

• Bachelor's Degree required

• Health-related or Business Management degrees preferred

Preferred Locations: Boston, North Carolina, Tennessee & San Francisco

For more information please contact Drew Bussey at RBW Consulting +44 (0) 1293 584 300 or send your CV to drew.bussey@rbwconsulting.com

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Clinical Monitoring Opportunities

Ref: AG-CMO-HB-UK-160120

Location: Home Based - UK

Type: Permanent

Multiple companies with different positions - All offer excellent benefits and working conditions.

Do you currently work within Clinical Research as a Site Monitor (CRA) and want to find out if your working conditions could be improved?

Do you believe you are perhaps overworked and that your work life balance is not at the level you would like?

Have you spent several years with the same organisation and wonder if your salary has been kept in line with the industry?

If you have answered yes to any (or all) of the above questions, then you should get in touch with me. I am working with a number of companies who are actively looking to recruit high calibre Monitoring professionals to work across different therapeutic areas and interesting projects. They are all known for helping their own staff progress through different positions and will always provide a clear and obtainable career path to new starters.

They all have excellent financial packages and can certainly provide excellent working conditions that will help you truly enjoy your work. One of my clients even offers a signing bonus of £5,000 to help the transition into your new job.

I would encourage you to have a real think about your current situation and if you would like to see a change and talk to me about how we can make this happen. Please give me a direct call or send me an email and we can arrange a time to have a private and confidential discussion.

Salary: On application