Clinical Development Physician - Psychiatry
Date Posted: Thursday, 26th of January 2012
Salary: £80,000 - £150,000
Start Date: ASAP
Telephone: 01438 743047
Location: Basel
Consultant Name: Moin Din
Sector: Pharmaceutical
Description
Senior MD / Clinical Product Development Physician - Neuroscience.
This Company is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Senior PD Medical Director leads development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Senior PD Medical Directors typically have direct reports. Senior PD Medical Directors are expected to perform their responsibilities independently and demonstrate mastery of the core^Medical Director role and effectively lead multiple projects; including participating in health authority (HA) interactions with little to no supervision from their managers.
JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:
Cross-Functional Team Leadership & People Management
Participates in and/or leads the relevant Clinical Science Team (CST)
Leads and/or otherwise represents CD in sub-teams (e.g. Study Management Teams) relevant to assigned molecule(s)/indication(s) and is responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
When assigned/appointed, acts as the Global Development Team Leader (GDTL). Where assigned/appointed, expected to represent CD on core teams, e.g., Lifecycle Team (LCT)
Accountable for training new CST members
May also, as appropriate, support relevant sub-teams in assigning and training new team members
Global Clinical Development Planning
Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
Maintains the highest standards and levels of scientific and clinical knowledge in the specifictherapeutic and diseasearea(s) of assignment
Represents CD for the assigned molecule(s)/indication(s) to other internal Company groups
Contributes clinical science input into the relevant therapeutic/disease area scientific strategy. Helps research^and other PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals. As appropriate/needed, performs clinical assessments on relevant drug discovery projects
Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input
Clinical Development Plan Implementation
Provides clinical oversight across all^relevant studies and programs
Leads and/or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
Designs and develops, or oversees others in design and development of, clinical studies
Collaborates with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials, and patient registries (including strategies for patient registry recruitment)
May guide and advise^others in the identificationand selection of appropriate external investigators and sites
Acts as CD lead in the development of study analytics and data management plans for relevant
QUALIFICATIONS & EXPERIENCE:
Must demonstrate mastery of the full Medical Director role; capable of assuming oversight responsibilities for multiple projects and teams
M.D. with relevant medical experience in same/similar therapeutic area required
Pharma/biotech industry experience OR is a recognized expert in the field Experience with clinical trials. In-depth understanding of Phase II - III drug development
Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
Experience authoring a globalclinical development plan
Experience publishing results of a clinical drug trial in a referred journal
Knowledge/understanding of Phase I & IV drug development is a plus
Academic/teaching background is a plus
Broad experience in the principlesand techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hearback from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23
