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Position	CLINICAL LEAD PVD
Company	Advanced Clinical Recruitment
Location	Kent
Country	United Kingdom
Job Description	Job Summary: My Client is looking for an MD with 10 years in the industry and excellent experience in pulmonary vascular disease. This is a unique opportunity with an excellent salary and career progression on offer. Requirements: Position Purpose • Clinical Lead is the single point of contact for the Medical Development Team Leader (MDTL) for each assigned project. • Responsible for creating the overarching strategy for the clinical development of the programs under his/her purview with a focus on innovative design, medical execution and interpretation. • Leads clinical development strategy and program execution of a development project. • Ensures alignment of the clinical development plan with medical and commercial strategies. • Applies medical and clinical development knowledge to translate clinical ideas into high quality clinical candidate and target go/no-go decisions. • Assures that the clinical development or lifecycle strategy fits within the overall disease area strategy/product concepts and integrated medicine plan for the drug or portfolio of drugs, such that the trials deliver the data which will demonstrate the value of our medicines to our many customers • Integrates scientific knowledge and operational expertise to ensure excellence in development and translation of clinical plans into efficiently delivered studies. • Chairs or delegates responsibility for chairing the Clinical Sub-Team. • Partners with clinicians and disease area experts from appropriate research units to develop success criteria for proof of concept (POC) studies with a candidate. • Works with statistics and other clinical staff (e.g., clinical pharmacology) in the review and interpretation of data; accountable for overall quality and timeliness of analysis and reporting. • Oversees clinical trial safety review, and analysis and tracking of emerging efficacy and safety profile of the drugs – if a physician, may act as “single voice of the medicine”. • Serves as principal contact on scientific and medical issues for Dev Ops, study managers/monitors and external collaborators and study sites during conduct of the trial. • Establishes relationships with key clinical experts/sites, and uses these relationships to help establish collaborations and enhance Clients medical/scientific reputation. • Be outward facing including learning/applying best practice from the external environment and being a key point of contact for clinical. • Drives scientific and technical excellence. Organizational Relationships: • Reports to Clinical Group Lead • Provides leadership within a project team of the matrix triad of the Clinical Lead, Clinical Pharmacologist and Statistician. Partners with Medical Development Team Leader in this regard. • Strong “interwoven” relationship with the Medical Development Team Leader (MDTL) and other Med Dev Team members. Resources Managed (budget and FTEs): • Functionally supervises study clinicians where appropriate. • Budget: allocated world-wide clinical trial budget. Primary Duties: • Accountable for design and final recommendations for clinical plans for compounds / indications overseen by their respective Medical Development Team, post POC to LOE. • Accountable for negotiating milestones and ensuring execution and delivery of the clinical plan in line with agreed timelines. • Leads the Clinical Team to design, execute and interpret post proof of concept (POC) studies • Acquires knowledge of competitor products and clinical plans, and maintains and enhances knowledge in relevant therapeutic or technical areas • Plans resources required both within CDMA and in conjunction with PGRD lines to accomplish the clinical objectives in a timely and resource-efficient fashion, including consideration of FTEs and operational resourcing • Responsible for developing, recommending, getting approval, and adhering to the clinical trial budget • Leads a motivated, committed and engaged Clinical Team towards the common goal of submissions of approvable regulatory filings that meet customer needs (patient, prescriber, health technology assessment), and/or in the conduct of peri- and post-approval studies which clearly establish the value or clarify the risk:benefit profile of the Medicine. • Models, expects and ensures effective team behavior to achieve the program goals • Leads clinical preparation for, and attends meetings with regulatory agencies worldwide, together with other relevant colleagues from the Medical Development Team • Leads preparations and presentation of the clinical content of regulatory submissions/documents • Accountable for ensuring regulatory compliance for clinical trials and reporting • Ensures seamless transition from Research to SC BU for drugs that have achieved proof of concept • Accountable for keeping Medical Development Team Lead and Clinical Group Head informed of clinical progress and any critical clinical issues, especially the emerging safety profile • Accountable for input and approval of clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, clinical sections of submissions (in conjunction with senior medical monitor if necessary) • Accountable for clinical expert panel meetings and advisory boards to give input on clinical plans • Presents to senior management and external audiences on clinical aspects of projects: including milestones, strategies, data • Contributes to high quality clinical review of post-POC licensing opportunities, coordinating clinical focused technical due diligence if required. • Involves internal disease area experts and consults with relevant technical advisory committee(s) to ensure high quality and efficient clinical development plans and protocol designs that reflect enhanced clinical trial design (ECTD) principles, enhanced quantitative drug development (EQDD) principles, and current disease area knowledge, with an eye on continuous improvement. • Contribute to technical review committees as appropriate. • Builds relationships with external investigators (KOL’s) to promote scientific discussions, smooth operational delivery and avid interest in Clients success. • Ensure excellence in support for the BU through education, training, mentorship and performance management; this includes challenging every clinician to design clinical plans and studies that improve the efficiency (value:cost ratio) of the project. Training & Education Preferred: • M.D. ,PhD, DVM and/or Pharm.D. or equivalent qualification • Demonstrated expertise in managing global clinical programs in late phase development or post-approval in the pharmaceutical industry • Expertise in the relevant disease area (PVD) • Expertise in managing large clinical programs in industry • Demonstrated strong collaboration with Development Operations colleagues Prior Experience Preferred • Proven track record of being a successful development team lead, clinical lead or truly outstanding study clinician / clinical scientist (preferably in late phase development, or post-approval, as applicable to role) • Previous effective management of clinicians. • Has demonstrated knowledge of designing, executing and delivering clinical programs, to produce both timely and good quality data, including knowledge (and appropriate use) of innovative clinical trial principles and methodologies (e.g. EQDD, ECTD etc). • Demonstrated experience in successfully leading teams: running them effectively, efficiently and on target. Capable of recognizing when team interventions are required to enhance team effectiveness and utilizing a variety of management and influencing techniques to ensure delivery of the program. • Proven ability to get results in a matrixed management environment • Knowledgeable of the commercial and environmental issues that drive clinical projects • Regulatory awareness – proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities. Technical Competencies: Competency Detail / Comments (specific skills, etc.) • Clinical development expertise • Scientific excellence • Presentation and analytical skills • Demonstrated ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy. • Comprehensive understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. • Demonstrated potential or ability to design , initiate and conduct clinical studies in industry, academic, or research clinic setting • Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents • Understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development • Proven scientific writing skills, with strong inter-personal , written/verbal communication skills, including ability to evaluate, interpret and present complex data Behavioral Competencies: Competency Detail / Comments (specific skills, etc.) • Networking, alliance building and strong peer relationships • Influencing • Innovation • Courage with decisiveness to Act • Team Working • Accountability • Personal development • Change agile • Self awareness • Able to work across many interfaces: clinical -regulatory; clinical -marketing; clinical -project management; clinical -development operations (biometrics, monitoring resource, study reporting); able to establish positive colleague relationships which further collaboration and cooperativeness • Able to lead multi -disciplinary group; ability to manage and motivate investigators • Constantly challenge existing paradigms in clinical research and encourage breakthrough designs • Bias towards action to achieving goals; make good decisions in a timely manner based on analysis, experience and judgment, even with incomplete information or under time pressure • Shares wins and success; foster open dialogue; let people finish and be responsible for their work; define success in terms of the whole team; create strong morale and spirit in his/her team; create a feeling of belonging to the team • Take personal responsibility for own work, pushing self and others to exceed goals and deliver results • Take accountability for own career development, regularly updating and acting on development plan • Demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change • Understand own strengths and limitations, and seek and receive feedback in a non-defensive manner • Model a personal alignment with Clients mission and vision, and behave consistent with culture and values
Company Profile	Specialist Pharmaceutical recruiter
Job Type	Full Time
Salary	Upto 0 Rs Per Month
Skills Required	PVD
Reference
Posted On	09 March 2010
Last Date to Apply	09 April 2010
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