A career with EMD Serono is an ongoing journey of discovery: our 51,000 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 operational delivery and execution of R&D sponsored programs for all corporate sponsored programs for Phase I - Phase IV.
The Associate Director, Clinical Operations Lead is accountable for the operational deliverables and key strategic input toward the implementation of the clinical development strategy of an entire clinical program (comprising of multiple trials, and/or multiple indications).
The Associate Director, Clinical Operations Lead contributes at an expert level within the therapeutic area(s) to the operational feasibility, direction, and execution of the program; provides perspective, in-depth knowledge, and demonstrates experience with identifying complex operational issues and challenges.
The Associate Director, Clinical Operations Lead is proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation. Leads and drives collaboration with CRO partner for high priority program delivery to ensure that expected timelines, budget, and quality is met.
The Associate Director, Clinical Operations Lead oversees and aligns activities of the Global Program Team, Clinical Operations Team, and other functions contributing to the program, in accordance to the program objectives.
Proven executive presence and senior leadership qualities and influencing skills; pronounced resiliency and ability to work under high pressure.
Who you are:
- Bachelor’s degree with 8+ years of experience, master’s degree with 3+ years of experience, or PhD degree in Biology, Chemistry, Pharmaceuticals, or related field
- Advance degree preferred
- At least 8 plus 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 and start up (including budget & resource planning) strongly preferred
- At least 6 years of experience executing a wide range of clinical trial activities, from start up through final study report as clinical trial leader (or related role such as clinical research physician/scientist) preferred
- At least 3 years of experience in leading a clinical program team comprising of several clinical trials strongly prefer
- Position requires both domestic and international travel up to 10% of time
Position can be in Billerica, MA, Rockland, MA, or remote if you reside greater than a 50-mile radius from our Billerica and 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.