PD Clinical Development Scientist
PD Clinical Development Scientist
Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - III) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Scientist for the HTT ASO program will participate in the development of the Clinical Development (CD) strategy and plan and support the assigned senior clinical scientist and PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the program.
PD Clinical Scientists have primary responsibilities for supporting the assigned clinical scientist and PD Medical Directors/ Clinical Development 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 Scientists are expected to perform their responsibilities independently.
PD Clinical 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 senior clinical scientist & PD Medical Director/Clinical Development Physician, participate in external interactions with health authorities (HAs).
Primary duties:
- Acquires and maintains scientific and clinical knowledge in the specific therapeutic area of HD and disease area(s) of assignment in PDN.
- Participates in the relevant Clinical Science Team (CST) and represents CD in sub-teams (e.g., Study Management Teams).
- As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc. May act as the lead CD representative on sub-teams.
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- Supports internal partners in transitioning ASO HTT into Phase III studies.
- Helps generate and review Phase III protocols and other information and provide CD input into these and in so doing make important contributions to the CD strategy.
- Supports senior clinical scientist, PD Medical Directors/Clinical Development Physicians by providing additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)
- Where applicable and assigned, supports PD Medical Directors/Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
- Provides strategic clinical science support for assigned studies and programs
Qualifications:
We are looking for a professional with a PhD or equivalent qualification and good medical competence and experience in Phase II / III trials. A background in neuroscience basic or clinical research is preferred and demonstrated scientific interest and curiosity.
In addition you:
- Have a good clinical research experience in working on a clinical team (or equivalent) and in in a diverse environment, with at least 3- 5 years in multi-site efficacy studies (Phase II/III) and hands on experience in the protocol development and set-up stage
- Are a strong team player, you have the ability to broaden one’s knowledge base and to get “up to speed” on a new indication within six months
- Are able to evaluate, interpret & synthesize scientific data, you can verbally present and critically discuss clinical trial data in internal and external meetings
- Can interact within Pharma Development to accomplish goals while providing needed coaching, support or disciplinary action at appropriate times.
Please ensure you talk to your line manager before making an application.
Successful candidates will ideally be based in either Welwyn (in the UK) or Basel (Switzerland). Applications close 23rd April 2019
Wer wir sind
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.
Job-Fakten
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Standort **United Kingdom, Welwyn Switzerland, Basel-City, Basel** - Funktion Research & Development
- Subfunktion Clinical Development
- Arbeitszeit Full time
- Funktionsebene Entry Level
- Art der Anstellung Regular
- Firma/ Division Roche Pharmaceuticals
- Posted since 2019/04/15
- Posted until 2019/04/23
- Job-ID 201903-107728
Kontaktieren Sie uns
Mr. Andrew Timothy Armes