Associate Director Clinical Development
vor 6 Stunden
Hobson Prior are currently looking for an Associate Director Clinical Development to join a brilliant pharmaceutical organisation on a contract basis. Our client is focused on a number of therapeutic areas.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- You will develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for the company's local medical organisations.
- Deliver clinical and scientific input and partake in the clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- For the position of Associate Director Clinical Development, you will be accountable for offering clinical leadership, medical and scientific strategic input, and participate in the development of trial linked documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for allotted clinical trial(s) coherent with Integrated Development Plan (IDP).
- Operating with appropriate Clinical Trial Team (CTT) members, you will guarantee clinical support of trials as required and perform ongoing medical and scientific analysis of clinical trial data with Clinical Scientific Expert(s) with suitable oversight from Medical Lead.
- As the Associate Director Clinical Development, you will be responsible for handling patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with proper oversight from Medical Lead.
- Offer input into final analyses and understanding including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
- You will support Clinical Development Head (CDH) with participating in peer-review of IDPs, CTPs, and any other clinical documents across various indications and programs.
- Partake in medical/scientific coaching of applicable company stakeholders on the disease area and compound/molecule. You may serve as on orator for franchise medical/scientific training.
**Key Skills**:
- Solid communication skills, written and oral.
- Robust interpersonal skills.
- Exceptional negotiation and conflict resolution skills.
- Demonstrated ability to operate independently or in a cross-functional team environment.
**Requirements**:
- Educated to an advanced degree level in a life sciences/ healthcare (or clinically related degree) is required for the role. A PharmD, or PhD is highly preferable to the role.
- Established ability to corroborate operative working relationship with crucial investigators.
- At least 3 or more years of experience in clinical research or drug development in an academic or industry setting spanning clinical activities in Phases I through IV.
- At least 2 or more years of participating in and achievement in all aspects of organising clinical trials (e.g., planning, implementing, reporting and publishing) in a global/matrix setting in pharmaceutical industry.
- Functional knowledge of the allocated disease area is desired with demonstrated ability to understand, deliberate and exhibit efficiency and safety data linking to clinical trial(s) or program level.
- Operating knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
- Fluent oral and written English.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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