Contract Associate Director Clinical Development

A global biopharmaceutical company is advertising a vacancy for a Contract Associate Director Clinical Development. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD), and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities:

• Integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy.
• Providing input & support to the Director of Clinical Development (DCD) in preparation for governance interactions.
• Acting as the lead for cross-functional teams in the delivery of clinical activities assigned (e.g. indication specific sub-teams, Investigator Brochure production, DSUR etc).
• Providing project leadership and management for cross-functional clinical submission teams in support of regulatory marketing applications and post registration product maintenance phases.
• Managing improvement or change projects within clinical operations or spanning multiple business areas.
• Leading cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time; managing resource and risk.
• Working closely with individual study leaders to provide appropriate oversight of a program of studies on behalf of director clinical development (DCD).
• Providing clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, external partner management) to support governance interactions and project start-up.
• Supporting the DCD in providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, feasibility, risk).
• Providing project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package).
• Managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT.
• Early adopters for new ways of working and act as ambassadors for change when leading teams.
• Identifying and resolving issues within the clinical project ensuring the escalation of the issue to the appropriate individual/functional/governance group for resolution.
• Leading large or complex deliverables (i.e. indication) and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations).
• Acting as AZ project interface as escalated from study teams with external (e.g. CRO) partners for externally managed/outsourced studies as appropriate.
• Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives:
  Contribute to functional and cross-functional initiatives as Subject Matter Experts
  * Mentor and support people development as appropriate.

Skills and Requirements:

• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.
• May require up to 25% travel

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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