Clinical Development Manager - Biotechnology, New Role!
Due to their continued success, the team is expanding and are now seeking to appoint a new Clinical Development Manager, exceptional career opps.
Summary about this job
Clinical/Medical Research
Company: Boehunter Healthcare
Location: Melbourne
Work type: Full Time
Salary: n\a
Phone: +61-8-6612-7342
Fax: +61-3-8014-5909
E-mail: n\a
Site: n\a
Detail information about job Clinical Development Manager - Biotechnology, New Role!. Terms and conditions vacancy
BOEHUNTER EXECUTIVE SEARCH
- Novel and Innovative Research
- Clinical Trials in Oncology and Other Therapeutic Areas
- Diverse Project Management Role
Our client is a highly successful and reputable Biotechnology organisation with an array of compounds at various stages of their development process, including non-clinical, clinical (Phase I-II) and commercialised products. Due to their continued success, the team is expanding and are now seeking to appoint a new Clinical Development Manager to develop and execute the clinical development strategy for designated projects.
With drive, energy and skill, you will be responsible for a range of initiatives, including:
- Contributing to the direction and managing the development and implementation of clinical strategy for local and/or global clinical trials;
- Participating in the development of related regulatory strategies, competitive business intelligence, and evaluation of the relevant emerging and current drug landscape;
- Identifying and engaging appropriately qualified expertise (eg, KOLs) to support project objectives;
- Contributing to the direction of and managing clinical trials to ensure the delivery of studies in accordance with agreed budgets and timelines. Tasks include: trial design, developing and preparing study protocols and trial-related documentation, identifying suitable CROs, coordinating the contract negotiation process and implementing appropriate feasibility studies, just to mention a few;
- Preparing and presenting high-quality presentations and documentation for various internal and external purposes;
- For select programs, and in conjunction with Regulatory Affairs staff preparing various high-quality documents for regulatory submissions (e.g. IND, IMPD, NDA) for US, Europe, Australia and other regions;
- Contributing to the preparation and conduct of regulatory authority meetings;
- Contributing to the development and maintenance of departmental SOPs in association with the QA group and other members of the clinical team;
- Assisting with the identification, analysis and management of risks associated with areas of responsibility and expertise.
To be successful, the ideal candidate will possess the following:
- 10+ years of overall professional experience in the clinical research/drug development field, including substantial Project Management experience;
- Degree in Pharmacy, Pharmacology or related discipline; PhD would be preferred;
- Experience in the Biotechnology or Pharmaceutical industry is essential;
- Prior Oncology experience is desirable but not essential;
- Team player and a collaborative approach;
- Ability to work effectively and successfully in matrix project teams;
- Ability to think ‘outside the box’, readily adaptable to changing priorities; and
- An outstanding ‘can do’ attitude.
To apply to this rare and exceptional opportunity, please forward your application with a detailed covering letter to [email protected], please quote reference no. LK3056B. Alternatively, for a strictly confidential discussion, kindly contact Lucia Kimonides on 0410 565 626.