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
KEY TASKS &
- Lead large early development
- 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
- Lead the Global Early Product
- Ensure the development of a
consistent, robust and commercially focused Target Product
Profile (TPP) focused on differentiation for commercial
- 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
- 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
- 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
- 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
- Maintain professional
relationships with Key Opinion Leaders and the scientific
- 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
PROFESSIONAL SKILLS &
- PhD or equivalent in relevant
- Publications in peer reviewed
scientific or medical journals
- Good scientific knowledge and
experience in TA
- Fluent in English is a must
(Company’s work language)
- German and/or French is an
PERSONAL SKILLS &
- 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
- 5 years minimum experience in
managerial positions, including large scale project
- 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.
- Strong mature leadership and
- Capability to lead complex
strategy formulation with cross-functional and long term
- Strong results
- Ability to represent the company
and to negotiate at all levels both internally and
- 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
The Company is an Equal Employment
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
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
Merck Serono S.A - 17 months ago