04 Jun 2019 Associate Clinical Project Manager
Associate Clinical Project Manager – Job Description
NeuClone is a clinical stage biopharmaceutical company focused on the development of biosimilar monoclonal antibodies. Reporting to the Clinical Director, you will be responsible for project managing the clinical development of NeuClone’s pipeline of biosimilar monoclonal antibodies and Fc-fusion proteins. You will bring excellent clinical project management, liaison and strategy input experience. You will oversee the planning, implementation, and completion of clinical trials conducted by the Contract Research Organizations (CRO). You will have full knowledge of regulatory guidelines as they relate to biosimilar monoclonal antibodies and ensure compliance with USFDA and EMA biosimilar guidelines in their development.
Responsibilities will include:
- Prepare and/or review study-related documents as they relate to the clinical study of each product (e.g., Clinical Protocols, Human Research Ethics Committee (HREC) submissions, Informed Consent forms, Investigator Brochures (IB), Pharmacy Manuals, Monitoring Plan, TGA CTN Online Form, ANZCTR Registration, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Produce documents & technical reports suitable for regulatory submissions, study plans for preclinical background research and present findings, including for clinical Site Initiation Visits (SIV) and board meetings.
- Prepare material (e.g. executive summaries, Requests for Proposals (RFP), etc.) to identify, select and engage with CROs and once selected interface with CRO to communicate detailed timelines and ensure that transferred obligations and performance expectations are met.
- Review and or submission of research ethics committee (HREC) & regulatory documentation to FDA/EMA/CDSCO requirements, including briefing documents for Biosimilar Initial Advisory (BIA) meeting and Scientific Advice meeting requests.
- Perform audits of third-party vendors, including Clinical Sites & reference product suppliers & distributors.
- Coordinate with CMO’s, for biosimilar quality according to established CoA, supply of sufficient clinical product, importation (including BICON permit) and TGA labelling requirements.
- Negotiate and manage the CRO contract, budget and payments for third party vendors, including Phase I units, PK/ADA analytical laboratories and clinical reference product suppliers & distributors.
- Oversee performance of CRO and other third-party vendors to ensure all clinical products are properly distributed and accounted for, compliance with study protocol and in accordance with corporate timelines;
- Review of invoices from CRO and other third-party study vendors to ensure that work is performed in accordance with scope of work.
- Follow established project management standards to develop and maintain integrated project plans
- Proactively identify and manage risks and issues (including a log, mitigations, and contingencies), by weekly teleconferences with CRO and clinical sites to ensure cost effective timely delivery of the project including by escalation if needed.
- Bachelor’s degree required, in the life sciences, clinical or other relevant technical areas. Advanced degree desirable (e.g., MS, PhD, PharmD, MD).
- Demonstrated experience in multiple aspects of project management.
- Minimum 2-3 years of clinical study experience, within bio pharmaceutical, biotechnology, or CRO organizations).
- 2-3 years of clinical project management experience at a sponsor or CRO company
- Knowledge of clinical trial concepts and practices, including international clinical research guidelines.
- In depth knowledge and experience in monoclonal antibody characterization, mode of action, analytical and bioanalytical methods and bioassays
- Knowledge and experience working in the pre-clinical and clinical development of biosimilars
- Ability to work effectively in a team environment, manage parallel projects and work in a fast paced and changing environment.
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences.
NeuClone will offer to the successful candidate an attractive remuneration package to include base salary, superannuation, employee share scheme and discretional yearly bonus
Applications must consist of the following:
Cover Letter: The covering letter should include your contact address and telephone number. It is an opportunity in not more than one page to introduce yourself and highlight the key reasons you should be considered for the role.
Resume: Give a brief history of your employment and experience that covers the following areas:
- Educational qualifications and professional affiliations that detail the full title of the qualification, the year awarded and the title of the institution attended.
- Employment history in chronological order, starting with current position and specifying dates of employment, title of each position, name of employer, main duties or accountabilities and achievements
- The names and contact details of three referees will be required to be provided after an initial successful interview.