Project Management GRED

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.

Provides statistical, clinical data management and programming for the medical department. Collaborates in the production of the study protocols, provides and/or facilitates sample size calculations. Reviews case report forms (CRFs) to ensure appropriate data collection, cleaning, statistical analysis and reporting of the study. Enhances understanding of statistical hypothesis testing and presentations

KEY ACCOUNTABILITIES

• Actively manage one or more pre-PoC projects in early drug development beginning at Hit Discovery (DPHD) through to phase IIa/IIb (PoC).


• Lead and manage project team and meetings to execute the project specific strategy. Upon program team request, work with the project team to create alternative development scenarios, each comprising costs, timelines, risks, and project valuation. Evaluate these options with the program team when developing the program strategy.


• Support the program leader(s) in defining the program strategy, stakeholder management and overall program leadership topics. Specific to the project managed, keeping abreast of evolving clinical development landscape, competitor activities, business risk factors and status of intellectual property rights


• Execute the project specific strategy by establishing, updating and tracking against benchmark-based project plans  in line with the approved global development strategy (costs, internal resources, deliverables, milestones, timelines) and document all assumptions made.


• Challenge team members on their functional project activities to ensure efficient and cost conscientious development.


• Work in close collaboration with project controller to forecast and track the budget. Provide project team with early warnings on possible budget variances. In case of major variations (according to established governance guidelines) inform program team and obtain governance approval.


• Define the critical path for the project and ensure that all team members are fully aware of and focusing attention on the critical path activities to avoid any slip of project timelines.


• Coordinate within the project team the preparation and update of key project documents or sections thereof (TPP, IGDP post DP0, etc.).


• Support the Program Leader with project specific input in presenting and obtaining approval of the program strategy by the respective governance body (ROC).


• In agreement with the program leader manage the internal (across functions, sites and top management) and external (investors, scientific community) project reporting and communication.


• Cooperate in set up and maintenance of project management systems and tools


• Accountable to the program leader(s) and the head of global project management in GRED

FINANCIAL DIMENSION

• Pre-DPLO (Lead Optimization), manage external contracts (depending on project, typically less than 1.3M USD total)


• Post DPLO, manage global project budget (external costs 26.05-130.26 M USD depending on stage)

STRATEGIC IMPACT

• Participates in development of project strategy for molecules in Early Development


• Responsible for operational management of project


• Key member of program team(s)

Failure to deliver quality molecule on time and budget from Early Development to next phase of development will severely impact company pipeline and performance

SCOPE OF PEOPLE RESPONSIBILITY

• Manage a cross-functional, interdisciplinary team in GRED without direct authority


• With Functional Heads, responsible for project objective setting and performance review of team members


• With Functional Heads, coach and mentor project team members to work with an entrepreneurial spirit

COOPERATION

Internal

•       All GRED function heads (L2, L3)

•       Project team members and function line managers

•       Various experts within functions related to the project/program

•       Development functions in Technical Operations

•       Global and local Finance, R&D Controlling

•       Legal and Intellectual Property

•       R&D Communications

•       Global Business Development (including Alliance Management, Portfolio Management)

External

•       CRO’s, CMO’s as needed for outsourced studies

•       External collaboration partners

•       Strategic development partners

CANDIDATE’S PROFILE

EDUCATION

• Advanced scientific degree (MS or PhD)


• Fluent in English, written and oral; basic knowledge of 2^nd language a plus


• Degree in project management or certification by recognized project management association (e.g. PMI, IPMA) highly desirable

WORK EXPERIENCE

• Minimum of 7 to 10 years professional experience in the global pharmaceutical or biopharmaceutical industry


• Thereof, a minimum of 5 years professional experience in management of early/late stage drug development projects


• 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 from “bench to bedside” - both small molecules and biologics - including research, nonclinical, clinical, chemical and pharmaceutical development, industrialization, regulatory and market access


• Excellent communication skills, both oral and written


• Strong interpersonal skills required for multi-cultural environment, including active listening and conflict resolution


• Excellent organizational skills; demonstrated ability to work on and balance multiple projects and timelines which must be advanced in parallel


• Strong analytical skills and ability to understand complex processes and problem solve


• Highly motivated and results-oriented


• Ability and flexibility to switch priorities / projects if necessary


• Proficient with Microsoft Office programs (Word, Excel, Powerpoint); knowledge and/or experience in project management and database management is highly desirable


• Good understanding of finance and accounting principles in pharma/biotech industry

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.