A career with EMD Serono is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
As a clinical pharmacology (CP) expert, you will support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the general population and subpopulations.
- Provide comprehensive understanding and interpretation of PK and/or PK-PD for protocol development as well as study report completion
- In a matrix team, and in close collaboration with experts from Quantitative Pharmacology (QP), design and implement the QP strategy, which includes the Clinical Pharmacology aspects, to advance the assigned projects.
- Provide leadership for risk assessment, mitigations, scenarios and proactive planning to ensure synergy and innovation among functions
- Independently leads the CP effort regarding PK and/or PK-PD data by developing/executing plans, review the results and communicating results to the study team.
- Provide expertise and know-how in designing and implementing CP strategy in clinical trials during all clinical phases
- Represent CP to interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to CP and drug development
- Act as a CP member to support QP in all its endeavors with respect to moving drug/product candidates through various millstones up to regulatory submissions and beyond.
- Support or improve the established processes and contribute to a supportive environment
- Contribute to continuous learning, keep abreast with current technology and updated with best practice within the Department
- Drive initiatives, lessons learned and best practices
- May act as Clinical Pharmacology Expert Team Lead as needed
- The candidate should also have excellent written and verbal communication, organization and interpersonal skills, a strong team-player and fully at ease in a matrix environment.
Who you are:
- Bachelor’s degree with 8+ years of experience, master’s degree with 3+ years of experience, or PhD is required
- PhD in pharmacokinetics, (bio)pharmaceutics, pharmacology, or related field, PharmD, or MD in Clinical Pharmacology is strongly preferred.
- Direct industrial experience for minimal 5 years of experience is strongly preferred.
- Skills with data analysis and experience in drug development in EMD Serono core therapeutic areas and modalities is a plus.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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, transgender status, marital status, 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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.