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Job Details

Head of Development

Company: Barrington James Clinical
Location:
Reference: js-headofdevelopment
Closing Date: 02 Feb 18
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

Head of Development

Requirements:

Title: Head of Development

Company: Biotech

Location: UK (Home/office based)

Reports to: COO

Direct Reports: Clinical Project Manager

Following a successful meeting with the Chief Operating Officer, my team and I are now partnering with an exciting growing Biotech/MedDev organisation based in the UK. This organisation are going from strength to strength and are keen to expand their senior management team. The Head of Development (HoD) has overall responsibility for generating and maintaining the individual plans for the products being developed by this exciting company and for ensuring cross-functional collaboration of both internal and external resource to develop and execute the plans.

 Overall Development

·        To participate in cross-functional project teams to help define and implement product development strategy and achieve project goals

·        To manage cross-functional project team activities with both internal and external resource, including arranging team meetings and tracking project timelines.

·        To alert the COO and other senior managers of any significant variations in project timelines

·        To provide estimated clinical costs for the project budget and track the external expenditure for the project as it progresses

·        To alert the CFO and other senior managers of any significant variations to the budgeted expenditure for the project

·        To participate in discussions with regulatory consultants and agencies and ensure that the product development plans include the required studies and data

 

 Clinical Development

·        To provide clinical development expertise in the development and management of a Clinical Development Plan and Risk Management Strategy

·        To provide clinical development expertise in the design, conduct, reporting and interpretation of clinical studies;

·        To provide and manage timelines and budgets for all clinical trial activities; as agreed with Senior Management Team. Any variations, with justifications and management strategy to be provided to Chief Operating Officer and/or other members of Senior Management Team.

·        To ensure that clinical studies progress in accordance with the agreed strategy and to provide clinical activity updates to cross-functional project team, Senior Management Team, and other collaborators, as required.

·        To propose resource and outsourcing strategy for the execution of clinical studies; for example external advisors, CROs, contract laboratories

·        To ensure that Sponsor responsibilities for clinical trial activities as per ICH-GCP and current regulations are met

·        To provide clinical development expertise in preparation of communication with regulatory authorities and represent Clinical Development at meetings with regulatory authorities as required; in conjunction with support from a Medical Advisor as appropriate.

·        Overall responsibility for ensuring readiness for clinical audits by external collaborators or GCP inspections by regulatory authorities. To lead the clinical team in preparations for and during any notified audits or inspections.

·        To ensure required processes and procedures related to clinical study activities and to be used such as SOPs, template documents and working guidelines are in place and regularly reviewed

·        To provide clinical development expertise in the preparation for due diligence by or of external collaborators

·        To provide leadership and oversight to direct reports to ensure high quality delivery of their responsibilities. Provide coaching, mentorship or propose formal training as required.

Experience and Skills

·        Minimum 15 years’ experience in clinical development; including significant experience of clinical project management and clinical programme management;

·        Able to demonstrate knowledge and experience of project management and clinical study management

·        Able to demonstrate experience of developing and delivering clinical development and risk management strategies

·        Experience of communication and meetings with regulatory authorities

·        Able to demonstrate thorough knowledge of ICH/GCP and EU & US clinical trial regulations

·        Knowledge of clinical trial regulatory procedures in Europe & US

·        A comprehensive experience of the full clinical study process, from protocol design, feasibility, study set up, initiation, execution, data management and reporting

·        Able to demonstrate flexibility, team leadership and motivation, line management skills, mentoring skills

·        Good written and oral communication, presentation and interpersonal skills with the ability to communicate effectively, negotiate at all levels, conduct meetings and present to a wide range of audiences, including Senior Management

·        Motivated and able to work without supervision

·        'Can-do' attitude, pro-active approach and enthusiastic outlook

·        Able to work within a small team environment

·        Demonstrate high standards of professionalism at all times

·        Scientific ability to understand technical, scientific and medical background of a development project

·        Experience with Microsoft Project

For more information, please reach out to me directly on jsalmon@barringtonjames.com

Or

01293 77 66 44 

If I am unable to take the call, please contact my colleague William Penticost - wpenticost@barringtonjames.com

Apply for this job: Head of Development

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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