Senior Associate Director, Clinical Development and Medical Affairs, Oncology
Location: Ridgefield Connecticut
Description: Boehringer Ingelheim is looking of Senior Associate Director, Clinical Development and Medical Affairs, Oncology right now, this position will be placed in Connecticut. Detailed specification about this position opportunity please give attention to these descriptions. Through development of relationships and contacts across departments,! as well as with outside organizations, consultants, and scientific experts, supports the drug development program and supports development of the national post-approval product maintenance and optimization plan. Helps set strategy for and provides oversight of phase IV and IIS programs. Provides support for other department core functions as need arises such as by support of Medical Legal Regulatory (MLR) or Therapeutic Area Medical Review Committee (TAMRC) team reviews, CME grant provision program, publication planning, and to Medical and Technical Information. Develops advisory/consultant board materials/strategies and provides support to field based medicine team, to Brand Team, as well as to other disciplines as needed. Provides medical/scientific input and advice to Clinical Operations personnel during the local planning, implementation, conduct, and reporting of clinical trials.
As an employee of Boehringer Ingelheim, you will actively contribute to the disc! overy, development and delivery of our products to our patient! s and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Responsible for strategic planning and oversight of post-registration trials, scientific evaluation of potential indications and assessment of operational feasibility including projection of timelines,cost for proposed studies and reporting of results to the medical community and regulatory agencies
Responsible for evaluation of National IIS studies as well as for supervision! of operational oversight of National IIS studies.
Gathers, reviews and critically assesses clinical information, incorporates analysis into written documents (e.g. for regulatory or ethics committee responses) and/or training materials. Develops and implements annual FBM scientific training plan. Provides critical clinical input/training across disciplines. Keeps up to date on scientific and medical progress in the area of development and actively develops and maintains relationships with outside experts in this area. Serves as a liaison by representing the company in outside groups including Managed Markets and Institutional customers.
Plans and implements advisory board meetings as the need arises.
Supports department in fulfilling additional core functions as needed.
Additional core functions include: support of Medical Legal Regulatory (MLR) or Therapeutic Area Medical Review Committee (TAMRC) team reviews,CME grant provision ! program, publication planning, Medical and Technical Information suppor! t, FBM Scientific Exchange Monitoring, and support across disciplines as needed.
Provides medical/scientific input and advice by working closely with local Clinical Operations personnel (TCM,CML,MRA)on clinical trial(s) being conducted in OPU.
Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, PLRT participation, interactions with Regulatory Agencies, and Annual NDA, IND Report and DSUR submissions.
Perform all Company business in accordance with all regulations (e.g. EEO FDA, OSHA, PDMA, EPA PhRMA, etc) and Company policies and procedures. Demonstrate high ethical and profession standards with all business contacts in order to maintain BIPIs excellent reputation within the medical and pharmaceutical community.
Requirements:
Masters Degree and/or Doctoral Degree with a focus in Medicine or Pharmacology and/or Professional training
Medical/professional training and/or clinical experience (including as a physician, nurse practitioner, or physician's assistant) in internal medicine or pediatrics and preferably the appropriate therapeutic area to ensure one's ability to provide accurate scientific expertise to Medical, Operations, and Commercial colleagues.
Those with a Masters degree in science must have 10 years of prior pharmaceutical company experience within the specific therapeutic area which might include experience as a Medical Science Liaison. Experience with clinical trial conduct either as a study investigator or industry medical/clinical monitor and knowledge of GCP.
Must have in depth knowledge of therapeutic area, clinical development, regulatory requirements, and have strong analytical and oral and written communication skills.
Must also work well both independently and in teams, have excellent time management skills and be able to work well under pressure.!
Desired Experience, Skills and Abilities:
Prior ex! perience in the Therapeutic Area required and may be fulfilled by prior clinical practice/academic medicine experience or prior experience in a Pharmaceutical company
International experience may be relevant but knowledge of US Medical practice is essential
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Our Culture:
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the st! eady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer ! Ingelheim conducts pre-employment background investigations and drug sc! reenings.
Job
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Clinical Research/Medical Affairs/Drug Regulatory Affairs
Primary Location
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Americas-United States-Connecticut
Other Locations
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Americas-United States-Connecticut-Ridgefield
Organization
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BI Pharma/BI USA
Schedule
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Full-time
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Boehringer Ingelheim.
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This position starts available on: Mon, 11 Mar 2013 09:38:38 GMT
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