Clinical Development Scientist - Neuroscience

Recruiter
Roche
Location
Hertfordshire
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Roche is one of the world’s leading R&D led pharmaceutical companies. With 100,000 employees in over 100 countries, collaborative innovation is at the very heart of the organisation.With recent exciting developments in the Neuroscience therapy area, we are increasing our Clinical Development teams in this field. The Clinical Development Scientist participates in development of the Clinical Development (CD) strategy and plan and supports the assigned Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Clinical Development Scientists have primary responsibilities for supporting Clinical Directors/Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting. PD Clinical Development Scientists are expected to perform their responsibilities independently. PD Clinical Development Scientists are likely to have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc. They may also, alongside the Clinical Director/Physician, participate in external interactions with health authorities (HAs). Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.Bachelors Degree required (life sciences preferred) Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.) Advanced clinical trial experience (sound clinical trial experience in pharma/biotech industry) Data listing review experience Experience working on a clinical team (or equivalent) Experience authoring aspects of a global clinical development plan or full clinical study protocol and publishing results of a clinical drug trial in a referred journal Strong relevant therapeutic area experience Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.) Comprehensive understanding of product and safety profiles Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations Proven abilities to perform Clinical Scientist responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Outstanding written communication skills Strong business presentation skills: highly effective at summarizing and presenting the key considerations and decision-points Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on- point, and is able to raise problems or challenges in a productive and mature manner Strong negotiation skills: can effectively drive discussions and decisions toward desired end results Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources Ability to travel (Although Basel and South San Francisco are possible locations for this role, ideally the successful candidate will be based in our Welwyn offices in the UK, and applicants should be open to relocating in order to achieve this. Good luck with your application. Closing date for applications is 4th March 2018 Who we are Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com. EEO is the Law PAY TRANSPARENCY NONDISCRIMINATION PROVISION The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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