Non-Clinical Safety Project Manager

EMD 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.

KEY ACCOUNTABILITIES

• Accountable for the management of projects in drug development beginning at Exploratory Development (ED) through to marketing authorization and including LCM activities in the field of Nonclinical Safety


• Provide high quality expertise on Non-Clinical Safety (general & safety pharmacology and toxicology) and represent Non-Clinical Safety (NCS) within Non-clinical Development Teams (NCD Team)


• Provide efficient and high quality NCS contributions to Program/Project Teams (PT) 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 NCD/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 Program/Project Team and manage collaborations /alliances associated with the projects


• Represent Non-Clinical Development within Program/Project Teams as NCD-Leader (NCD-L)


• As NCD-L act according to defined NCD-L key accountabilities, especially facilitate provision of high quality expertise on DMPK, and biomarker technology including testing strategies, strategically oversee contributions of other NCD representatives on the program and act as multilateral interface between PT-Leaders, NCD team members, NCD line functions and NCD management, and other functions


• Chair the NCD team Meeting; develop agendas, schedule, attend, operationally lead team meetings, and take minutes
• Assist the Head of NCS/Gobal Project Support with respect to delivery of efficient and high quality contributions to incoming requests from other Merck Serono functions and Health Authorities as well as for LCM activities.


• Contribute to in- and out-licensing activities

FINANCIAL DIMENSION

• Supervise, adhere and adapt NCS/NCD–related budget within the Program/Project Team


• Manage external contracts

STRATEGIC IMPACT

• Key member of the Program/Project Team


• Present and discuss the NCD development strategies within the Program/Project Team


• Drive a project according to NCD development strategy and the project’s TPP

SCOPE OF PEOPLE RESPONSIBILITY

• Manage the cross-functional, interdisciplinary NCD Team within a Program/Project Team without direct authority


• With Head of NCS/NCS Project Support, coach and mentor project team members to work with an entrepreneurial spirit


• Coach junior NCS PT members

COOPERATION

• Ensure and maintain international contacts/discussions with key opinion leaders, consultants, scientists, contract research organizations (CROs) 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 NCD/NCS function


• Within the NCD Team, provide transparent  and easily accessible information on non-clinical safety and non-clinical development aspects


• Facilitate and contribute to proper communication within Global NCS and all relevant interfaces


• Coordinate workflows with interacting areas/groups within and outside NCS/NCD

CANDIDATE’S PROFILE

EDUCATION

• Advanced scientific degree, DVM; PhD in life sciences (Toxicology, Biology, Physiology)

WORK EXPERIENCE

• At least 2 years academic experience in a theoretical medical discipline (Physiology, Pharmacology or Toxicology)


• 5 to 7 ( ideally 10) years experience in Pharma R&D, including an international environment


• Demonstrated successful 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 compley processes


• Strong alliance management skills


• High degree of communication, facilitation and problem solving attitude

ADA REQUIREMENTS

• 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.