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Associate Director, Trial Clinical Delivery Lead
A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As a Trial Clinical Delivery Lead you drive performance of your assigned studies and contribute to company strategic objectives. Being a strong clinical operations expert within the global trial team, you identify risks, opportunities and facilitate proactive action planning. Working across the clinical development portfolio (Phase I – III), you are accountable at the trial level for overseeing delivery and quality of site-level activities, developing operational excellence and site and patient engagement strategies - leveraging expertise from key partner functions and leading team implementation. You bring the voice of the patient into the drug development process, ensuring insights are translated into study design and conduct. Additionally, become an expert on tactics for trial decentralization, patient recruitment and retention, and supporting the company’s diversity and inclusion objectives. You collaborate at the trial team level to identify optimal strategies considering program and study characteristics, manage implementation and measure tangible impact. You will utilise site performance and quality data analytics to drive risk-based sponsor oversight activities for investigational sites in outsourced studies. You will provide leadership, strategic direction and operational oversight for Clinical Site Leads across assigned study(ies) who perform site engagement, vendor and site oversight at the site level; developing study plans and ensuring implementation, identifying trends and supporting action planning.
Who You Are:
- Bachelor's Degree in a Medical or Life Science discipline (essential); PhD desirable
- 10 years clinical operations experience from a CRO, pharma and/or biotech company
- Extensive experience in site management/oversight (including management/oversight of CRA teams and/or Lead CRA experience), vendor management/oversight
- Thorough knowledge of ICH GCP and global/local country regulations
- Ability to build and lead high-performing teams in a matrix organization
- Proactive, deliverable focused and solution orientated with clear understanding of ownership and accountability
- Capability to work independently on assigned tasks or projects of increasing complexity
- Strong analytical skills, aptitude to interpret outputs from analytical tools to enhance and improve study execution
- Comfortable working in a fast‐paced environment where speed is paramount
- Strong communication skills - verbal, written and listening - both in native language and English
- Experience in/knowledge of patient centric activities, recruitment and retention strategies and technologies, clinical study management (planning and conduct)
- Broad therapeutic area experience ideally relevant to our company portfolio
- Approaches change positively; adapts behaviour or work methods in response to new information, changing conditions, or unexpected obstacles
- Aptitude to network and use appropriate interpersonal styles to establish constructive working relationships with peers and partners to meet mutual goals and objectives
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.