Global Project Support Representative, Global Nonclinical Safety
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POST DATE 8/19/2016
END DATE 2/14/2017
JOB DESCRIPTIONEMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
* Accountable for the management of projects in drug development beginning at Exploratory Development (ED) through to marketing authorization and including life-cycle-management (LCM) activities in the field of Nonclinical Safety
* Provide high quality expertise on Nonclinical Safety (general & safety pharmacology and toxicology) and represent Nonclinical Safety (NCS) within the Global Early Development (GED) and Global Product Teams (GPTs)
* Provide efficient and high quality NCS contributions to GPTs including an appropriate NCS testing strategy in alignment with line functions, the clinical development program concerned and the target product profile (TPP) in an environment of highly complex and international regulatory requirements, depending on product class, mode of action, therapeutic area, patient population and medical need
* Analyze data/results of in silico, in vitro, in vivo studies and bibliographic data, put into strategic perspective and in lieu thereof compile NCS assessments
* Contribute to the safe administration of pharmaceutical development compounds in humans and prepare recommendations for decision by relevant governance bodies; between decision points: analyze new GED/NCS relevant information, foresee impact on project and program strategy
* Ensure appropriate content and format of NCS parts of all regulatory relevant documents including Investigator Brochures, clinical trial applications (e.g. IMPD/INDs), global marketing authorization applications (e.g. BLA/NDA) and other filings in compliance with up-to-date regulatory requirements, global and internal standards and processes
* Ensure that relevant regulatory requirements are met within an efficient, cost-effective and state-of-the-art scientific environment to successfully facilitate all Health Authority interactions with NCS involvement
* Ensure completion of allocated NCS work-packages in adequate quality and within agreed time lines
* Facilitate information flow within the NCS functions and the GPT and manage collaborations /alliances associated with the projects
* Represent GED within GPTs as GED-Leader (GED-L)
* As GED-L act according to defined GED-L key accountabilities, facilitate provision of high quality expertise from the GED functions including Quantitative Pharmacology and Drug Disposition (QPD), and Clinical Biomarkers & Companion Diagnostics, strategically oversee contributions of other GED representatives on the program and act as multilateral interface between GPT-Leaders, GED team members, GED line functions and GED management, and other functions
* Member of the GED team Meetings; as GED-L, chair the GED team Meeting; develop agendas, schedule, attend, operationally lead team meetings, and take minutes
* Assist the Head of NCS/ Project Support with respect to delivery of efficient and high quality contributions to incoming requests from other EMD Serono Biopharma functions and Health Authorities as well as for LCM activities.
* Contribute to activities for due diligence evaluations, for LCM and mature compounds
* Provide support to early development project teams (DPTs) based on agreed extent
* Permanent member of the NCS Project Support Group Meetings
* Supervise, adhere and adapt GED/NCS related budget and resource planning within the GPT
* Manage external contracts
* Support the Head of NCS Project Support with respect to NCS development strategies
* Presentation and discussion of GED/NCS development strategies within the GPT
* Drive a project according to GED/NCS development strategy and the project s TPP
SCOPE OF PEOPLE RESPONSIBILITY
* Manage the cross-functional, interdisciplinary GED Team within a GPT without direct authority
* With Head of NCS Project Support, coach and mentor project team members to work with an entrepreneurial spirit
* Coach junior NCS GPT members
* Ensure and maintain international contacts/discussions with key opinion leaders, consultants, scientists, contract research organizations and Regulatory Authorities in the field of NCS
* Initiate and coordinate experimental work/medical writing necessary for respective projects in close corporation with the responsible GED/NCS function
* Within the GED Team, provide transparent and easily accessible information on NCS and GED aspects
* Facilitate and contribute to proper communication within NCS and all relevant interfaces
* Coordinate workflows with interacting areas/groups within and outside GED
* Live and spread the EMD Serono values
CANDIDATE S PROFILE
* Advanced scientific degree, DVM; PhD in life sciences (Toxicology, Biology, Physiology)
* At least 2 years academic experience in a theoretical medical discipline (Physiology, Pharmacology or Toxicology)
* 5 to 7 years of experience in Pharma R&D, including an international environment
* Demonstrated working experience in cross-functional teams, ideally in global drug development in pharma/biotech
JOB-SPECIFIC COMPETENCIES & SKILLS
* Sound understanding of drug development process - both small molecules and biologics- including research, clinical, CMC Development/manufacturing and regulatory with special emphasis on nonclinical safety
* Broad knowledge of non-clinical safety and toxicology, R&D processes and regulatory requirements, Toxicology Board (ABT) Certification advantageous
* Good leadership skills
* Fluent in English, written and oral; ideally one other (European) language
* Strong analytical, time and resource management skills and ability to understand complex processes
* Strong alliance management skills
* High degree of communication, facilitation and problem solving attitude
ADA REQUIREMENTS (MANDATORY FOR US EMPLOYEES)
* Normal and routine office duties
* Position requires international travel up to 20% of time
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.