Early Product Development Leader
1828 EMD Serono Research Insti - Billerica, MA

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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.

PURPOSE OF THE ROLE
  • Lead large early development programs
  • Successfully lead cross-functional teams responsible for all aspects of development strategy, plans and associated execution for molecules in Early Development from DPLO through PoC
  • Accountable for all team decisions and recommendations.
  • Mentor/coach other Early Product Development Leaders
KEY TASKS & RESPONSIBILITIES
  • Lead the Global Early Product Development Teams
  • Ensure the development of a consistent, robust and commercially focused Target Product Profile (TPP) focused on differentiation for commercial success.
  • Translate the TPP into different strategic development options and secure approval of the recommended one by the ROC.
  • Prepare (with team members) a consistent, robust, cross-functional development plan for the approved development option and secure approval by the ROC Ensure an efficient execution and delivery of the development plan within agreed timelines & resources. Proactively identify and mitigate risks.
  • Ensure high quality and content of all project documentation.
  • For decision points, analyze with the team results/data and put into perspective, evaluate consequences for target product profile and development strategy, develop scenarios, perform risk analysis, develop mitigation plans and refer team recommendation for next steps to management.
  • Between decision points, analyze any new information with team, foresee their impact on project strategy/chance of success, and recommend to management a change in project strategy/objectives, if needed.
  • Take the project decisions that do not affect the development strategy (significant changes in budget or timelines require approval).
  • Manage the budget and challenge the functions about deviations. Responsible for a cost-effective approach to all development plan activities.
  • Ensure appropriate internal/external communication of the project in accordance with corporate policy.
  • Manage, guide, challenge and motivate the team members. Responsible for objective setting and performance review of team members.
  • Ensure that all involved functions are kept updated and coordinated concerning project progress. Assist team members in overcoming any obstacles to delivery of the project outputs.
  • Responsible for optimal staffing of the team and appointment of team members.
  • Support Alliance Management function (within Business Development) with external partners.
  • Maintain professional relationships with Key Opinion Leaders and the scientific community.
  • Maintain updated knowledge of the disease are and competitor development activities, business risk factors and status of Intellectual Property rights for the molecule.
  • Support the EPD Head in setting consistent standards and practices across the department

CANDIDATE'S PROFILE

EDUCATION/LANGUAGES
  • PhD or equivalent in relevant scientific discipline
  • Publications in peer reviewed scientific or medical journals
  • Good scientific knowledge and experience in TA
  • Fluent in English is a must (Company‚Äôs work language)
  • German and/or French is an asset
PROFESSIONAL SKILLS & EXPERIENCE
  • Sound scientific understanding & knowledge of the TA
  • Expertise in company processes and all specific functional processes related to drug development (early development, pre-clinical, process development, clinical and regulatory).
  • Recent small Biotech experience is necessary
  • 5 years minimum experience in managerial positions, including large scale project management desirable.
  • 10 years in Clinical Development with a sound awareness of pharmaceutical business including regulatory, sales & marketing related issues.
  • Led several high profile Development and Early Development programs.
  • Demonstrated success in position which influences and interacts with other departments.
PERSONAL SKILLS & COMPETENCIES
  • Strong mature leadership and interpersonal skills
  • Capability to lead complex strategy formulation with cross-functional and long term thinking
  • Strong results orientation.
  • Ability to represent the company and to negotiate at all levels both internally and externally.
  • Solid influencing skills and ability to interact constructively with all functions in a matrix organization environment.
  • Inspirational and motivational leadership to align team to the company vision
  • Top class verbal and written presentation skills with well-structured communication ability in various forums/audiences.
  • Sound strategic orientation
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.

Merck Serono S.A - 17 months ago - save job - block
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