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.
Clinical Trial Management is responsible for the strategic and tactical clinical operations delivery and execution of the clinical development strategy (Phase I to Phase IV) for all corporate R&D sponsored programs.
The Director, Clinical Operations Lead is accountable for the development and the execution of the clinical operations strategy of an entire clinical program (comprising of multiple trials and/or multiple indications). The Director, Clinical Operations Lead provides operational oversight, leadership and strategic input for the execution of a clinical program within the approved timelines, budget and expected quality standards.
The Director, Clinical Operations Lead is a core member of the Global Program Team representing all Global Clinical Operations functions; leads the Clinical Operations Team (includes Clinical Trial Leaders and cross-functional program team representatives) and is accountable for its performance and results in alignment with the Global Program Team objectives.
The Director, Clinical Operations Lead contributes at an expert level within the therapeutic area(s), interprets and anticipates internal and external business challenges and drives innovative clinical operations strategies; uses expert judgement to make sound decisions and drive strategies for the resolution and mitigation of complex operational issues and risks; facilitates program level escalations with the CRO partners and internal stakeholders.
Who you are:
- Advanced degree in Life Sciences (such as a graduate degree) (e.g., Biology, Chemistry, Pharmaceuticals) or equivalent medical background.
- Expert understanding of Oncology or Neurodegenerative Diseases or Immunology (depending on the assigned program(s)).
- At least 3 years of experience in a senior leadership position directing the clinical operations strategy of a global development program (comprising of several global clinical trials and indications) and developing and mentoring junior colleagues; proven executive presence and senior leadership qualities and influencing skills; pronounced resiliency and ability to work under high pressure.
- At least 10 years of experience in clinical research in pharmaceutical and/or CRO industry, including profound experience in the clinical drug development process and all aspects of clinical trial planning (including budget & resource planning), and in executing a wide range of clinical trial activities, from startup through final study report, with at least 6 of those years leading and managing global clinical trials (or related role such as clinical research physician/scientist).
- Position requires both domestic and international travel up to 30% of time
- Bachelor’s degree in biology, chemistry, pharmaceuticals, or related field, with 10 plus years of experience, master’s degree with 5 plus years of experience, or PhD degree with 3 plus years in biology, chemistry, pharmaceuticals, or related field
This role can sit at our Billerica or Rockland, MA location.
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.