A leading Australian pharmaceutical company is looking for Clinical Research Physicians with industry experience to contribute to the medical management of R&D studies and development programs by providing medical and scientific leadership to cross-functional therapeutic teams. CRPs input to study design, develop trial-related documents, oversee clinical trials, analyse clinical data and write study reports and regulatory documents.
A speciality biopharmaceutical company with more than 90 years’ experience developing new important biotech medicines for serious medical conditions is offering excellent relocation packages to fill permanent roles at its HQ. Employing more than 9000 people in 27 countries, the company is rapidly expanding its development portfolio, creating exciting new opportunities in clinical R&D.
Clinical Research Physicians
Key aspects of the roles
• Lead the generation of protocol synopses in support of proposed clinical trials and present the medical and scientific approach to protocol development teams
• Help finalise clinical study protocols and case report forms, support documentation e.g. institutional review board
• applications and informed consent documents
• Assist with the planning of clinical studies, including feasibility assessments, Investigator selection, participation at project kick-off and Investigator meetings and study review meetings
• Review study specific plans covering aspects such as data coding conventions and data reconciliation procedures and develop and maintain study specific medical responsibility plans to describe all medical monitoring activities required for a specific study
• Act as Medical Monitor with responsibility for medical review of eligibility and enrolment related issues and in collaboration with Clinical Safety Physicians make recommendations regarding ongoing patient eligibility
• Assist in the assessment of Serious Adverse Events
• Lead the establishment and management of Protocol Steering Committees and Clinical Endpoint Adjudication Committees
• Provide support to Biostatistics in the development of statistical analysis plans, ensuring consistency between protocol objectives and proposed analytical approaches
• Support data coding review and the analysis and interpretation of clinical trial efficacy data
• Provide medical review for, and where required, write assigned clinical efficacy sections for documents such as clinical study reports, Investigator Brochures and regulatory submission documents (IND/CTA/BLA)
• Present clinical trial results for discussion at internal review forums
• Contribute clinical input to regulatory submission documents and to regulatory agency responses
• Develop and provide therapeutic area medical expertise to support cross functional Clinical Expert Teams and provide therapeutic area training to internal and vendor (CRO) clinical project teams
• Contribute to the development of Clinical Science Specialists through active participation in training and mentoring activities
Coupled with a sound background in clinical medicine and preferably encompassing Cardiovascular, Immunology or Haemato-Oncology medicine, applicants must have pharmaceutical industry or CRO experience and be fully aware of all aspects of clinical development and ICH-GCP.
Key requirements are
• Excellent written and verbal communication skills
• Ability to evaluate, interpret and synthesize scientific data
• Capability to self-start
• Team player with ability to function in a multi–disciplinary environment both independently and in cross-functional teams
• Self-motivation with ability to prioritise and plan effectively
All candidates must be medically qualified and fully registered.
Highly competitive salary, pension, bonus, shares, life assurance, health cover, excellent relocation package and more.
Only Medics Recruitment Ltd is uniquely dedicated to recruiting doctors from entry to senior level positions for more than 90 client companies across the pharmaceutical industry, regulatory, devices, biotechnology and CRO sectors. An exclusive or preferred provider for many companies, only medics is established as the company of choice for medical recruitment.
only medics is directed by Caroline Lock who has more than 10 years’ pharmaceutical industry recruitment experience in scientific development and clinical research working with leading pharmaceutical companies and CROs. Caroline started her career in the NHS and worked with medical professionals in academic and clinical environments across a variety of specialities before joining the pharmaceutical industry in 1997 with Merck Sharp and Dohme. She moved into recruitment in 1999 and has recruited successfully across a broad spectrum of executive and clinical roles.
Only Medics Recruitment Ltd is able to draw on operational synergies with its sister company, Clinical Professionals Ltd, formed in 2006 by Caroline and her business partner James Nyssen.
Dr Elaine Ford is a Non Executive Director of Only Medic Recruitment Ltd. With more than 20 years’ experience in the pharmaceutical and CRO sectors, Elaine has a formidable track record as one of the most successful and respected recruiters for medical and executive appointments and in recent years has been a regular presenter and writer on pharmaceutical, management and recruitment topics.
For more information about the wide range of medical opportunities we recruit for, contact us for a confidential discussion on 01189 522799 or visit our website at www.onlymedics.com