Sr. Director / Director - PreIND & Phase I

Senior Director / Director – PreIND & Phase I Job Statement/Job Purpose:The position of Director PreIND & Phase I is responsible to put in place systems and procedures to ensure that clinical trials with the medicinal products under development are in accordance with applicable regulatory requirement.Qualifications: Ph.D in an area of Science, from a highly reputed medical school in India / abroad. We would prefer a candidate with a research background in drug development for the pharmaceuticals industry in the preclinical & phase I trials. Education Level:  Ph.D / Post doctoral degree is must.Location: Bangalore, India Years of relevant experience: A total experience of at-least 14-18 years, of which the last 3-4 years in a research leadership role in NCEs in large pharma companies.  Key Attributes of the candidate: The incumbent should have a mixed experience of working both in a major Pharmaceutical & medicinal environment. The candidate should have demonstrated experience & success in PreIND & Phase I areas & target leads with including managing reasonable portfolio of integrated programs in the last 3-4 years. Experience should span from TARGET to CANDIDATE SELECTION.  The candidate should possess excellent judgmental and decision making capabilities. Strong networking skills with experts in academia & industry. The incumbent must be very collaborative & also mature in managing a large group of individuals in mentoring & nurturing capabilities. Should have also worked in a collaborative research environment.  Principal Accountabilities:   Providing oversight and direction to the PreIND & Phase I Medical Strategy team in developing and implementing programs that support the PreIND & Phase I portfolio. Ensuring on-time performance and defect free execution of Phase I clinical trials while fostering strong client relationships. Providing leadership and oversight to all clinical, clinical laboratory, bio-analytical, and data management work. Directing the design, development and execution of clinical drug development plans and coordinating its implementation across the functional matrix, including tracking and coordination of PreIND and Phase I clinical activities by the team members in CM&C (API, formulations), ADME, pre-clinical trials, pharmacokinetics, toxicology and regulatory affairs. Serving as Project Leader for PreIND & Phase I projects and other projects as assigned. Responsible for creating and updating project timelines & appropriate project team communications / summaries. Contributing to Target Product Profiles, Project Plans, Target Product Claims and Translational Science Plans. Working with appropriate team members / corporate partners to develop efficient systems, SOPs which support drug development and which are compliant with FDA regulations, Indian Regulation and the ICH guidelines. Responsible to design and execute Phase I Clinical trials to establish Proof of Principle and to support Proof of Concept. Providing clinical scientific input for final study reports and annual report documentation. Providing consulting expertise as needed across discovery research efforts to provide appropriate clinical pharmacology input and focus to projects and programs at all stages. Overseeing the writing of clinical sections of regulatory documents including protocols, Investigator Brochures, IND annual reports, and others as needed. Creating and maintaining the PreIND & Phase I project budget for our client and reports to senior management. Attracting, assessing, retaining and developing highly competent, experienced personnel who contribute positively to team spirit, creativity and technical depth, challenge status quo and seek innovative ways to address business opinion leader needs. Establishing goals and values that promotes high performance of specialized project teams and drive the organization toward competitive standards. Create and communicate a compelling vision inside and outside the company that generates excitement, credibility and supports of the departmental mission. Responsible for the timely preparation and quality of relevant documents (protocols, final study reports, IND and NDA summaries) or contributes to documents (INDs, NDA expert reports; review of CRFs produced for clinical studies); evaluation of Clinical Pharmacology data (pharmacokinetics, pharmacodynamics) from clinical studies.  Key Competencies Required: Decision Making Business Understanding Communication Prioritization Problem solving LeadershipManagement Recruiters of Wrightsville Beach (The Port City Group, Inc.) is an executive search and recruitment firm specializing in biotech and pharmaceutical industries with a wide range of reputable clients across the country. ALL RESUMES REMAIN CONFIDENTIAL.  Qualified candidates, please send WORD resume, cover letter highlighting strengths for the position and daytime phone number to:  Lindsay Body bodyhr@bellsouth.net      MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-NJ-Bangalore, India JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: PreIND & Phase I COMPANY: MRINetwork EMAIL: Apply by Email