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Director of Clinical Trial Management – Oncology/Hematology

Ref: RG-DOC –OH–ONC/HEM

Location: Ohio/Remote US

Type: Permanent

Presented is an opportunity for a Director of Clinical Trial Management for a well-established CRO based in the Midwest. Our client is looking to bring on an experienced Director to provide both hands-on and strategic leadership within their Oncology/Hematology division.

This resource will be responsible for leading the progress and development of the Oncology and Hematology programs that are focused in cell therapy and transplant trials. This position will be client-facing and be tasked with supporting BID defenses and new client relationships.

Our client is a global brand that has successfully partnered with top pharmaceutical, biotechnology, and medical device companies worldwide.

Qualifications

• Master’s degree or PhD.
• 10 years relevant industry experience
• 3 years as Director of Clinical Operations/5years as an Associate Director
• Recent/Relevant experience within Oncology, Hematology, cell therapy, or Cart-T trials.
• Expertise in FDA, ICH/GCP guidelines
• Strategic and Tactical approach
• Strong ability to lead and mentor staff and willingness to work on the ground at times
• Exceptional written and verbal communication skills

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Rob Giarratani at (617) 982 1238.

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Principal Medical Writer / MedComms

Ref: RE-0475

Location: Central London / home-based

Type: Permanent

I’m looking for a Principal Medical Writer for a leading global medcomms agency who have an excellent reputation and a great culture.

Established more than a decade ago, this dynamic agency has grown considerably over the years while retaining an entrepreneurial feel. They are a strategic partner for pharmaceutical clients, enjoy taking on unique and interesting projects, and most of their work is global.

With a strong focus on meetings and events, the agency cover a broad spectrum of work that includes training materials, education for HCPs, creative and digital, and launch communications.

As PMW you’ll lead the development of high-quality scientific content for allocated accounts. You will act as a trusted advisor to clients, help to develop account strategy, and oversee the work of junior writers. You’ll be joining a well-structured editorial team with plenty of senior support and expertise to help you excel.

This agency is committed to the development of their people. They have a dedicated Learning and Development Director who works with staff at all levels, with lots of opportunities for internal, external, and on the job training.

Their offices are modern, plush and centrally located. You’ll also enjoy excellent benefits and flexible working.

You will need a strong scientific background and significant experience in a medical communications agency environment (ideally to PMW level), along with superb client facing and leadership skills, and impeccable attention to detail.

For more information please contact Rebecca Evans, Senior Healthcare Communications Consultant on 01293 584300 or email rebecca.evans@rbwconsulting.com

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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.