Associate Director Clinical Trial Lead
Associate Director Clinical Trial Lead
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1 Vacancy
Job Description
About This Role
Make the most meaningful impact of your career in this rewarding role with Biogen a well established pioneer in the pharmaceutical industry. This is your rare opportunity to transcend daytoday management operations as you design operational strategy and oversee our clinical research organization (CRO) partners to develop clear protocol concepts and final protocols. The best part: You will own responsibility for entire clinical trial studies including operational design successful delivery and the positive impact on the lives of patients with a wide array of conditions including nephrotic conditions multiple sclerosis (MS) Alzheimers disease and spinal muscular atrophy (SMA). Working from home office or both on a flexible hybrid schedule youll have the support of a team with wellestablished procedures in place to make your vision a reality.
What Youll Do
- Develop and oversee implementation of the studylevel operational strategy for the successful delivery of clinical studies.
- Chair the Clinical Study Team (CST) to drive development of scientifically robust operationally feasible and clear concepts/protocols.
- Oversee delivery of studies by CROs to ensure quality in line with time and budget forecasts.
- Partner with the CRO SMT lead to ensure the CRO creates appropriate riskmitigation plans and effectively identifies/resolves issues.
- Establish and drive efficient team operations by establishing an open culture defined by communication goal setting and oversight of strategy implementation.
- Ensure effective consistent efficient and compliant processes.
- Champion synergies among other studies programs and development units to enhance excellence in study planning and .
Who You Are
Scientifically and clinically astute youre a missiondriven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than daytoday operations. Decisive analytical and selfconfident you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
Qualifications :
Required Skills
- Bachelors Degree in a scientific discipline
- 8 years in clinical operations management overseeing outsourced clinical trials per quality timeline and budget expectations preferably with a sponsor company and/or a CRO
- Related scientific and clinical expertise and exceptional projectmanagement riskassessment contingencyplanning and communication skills
- Extensive knowledge of clinical development related to one or more trial phases (I II III or IV) as well as crossfunctional drug development
- Unquestioned expertise in Good Clinical Practices (GCP) International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development
- Ability to establish operational plans and support the CRO in executing them
- Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model
Preferred Skills
- Experience operationalizing nephrology clinical studies
- An advanced degree such as a masters or PhD in a related field
- Investigator site and/or monitoring experience
Additional Information :
The base compensation range for this role is $. Base salary offered is determined though an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity. Regular employees are eligible to receive both short term and longterm incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing; including but not limited to:
Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short and LongTerm Disability insurance
A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31
Up to 12 company paid holidays 3 days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
