This is a new job opportunity at a biopharmaceutical company focused on developing cancer treatments. They are currently recruiting for an experienced and motivated Clinical Associate Director to join their expanding team in Cambridge. This is an exciting time to join this company who operate across the United States, Europe and other international markets and have an extensive pipeline of products under development. This individual must be highly motivated and enjoy working in a fast paced, dynamic, matrix environment. Must be able to interact cross-functionally at all levels within Our client and externally with consultants/contractors, investigators, and study coordinators. Understands that our client is a small company and the job scope/role will inevitably evolve as the company grows and matures, therefore flexibility is needed. Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities. The Clinical Associate Director will be accountable for managing the overall clinical operational activities within Clinical Operations. Additional responsibility may be assumed for other projects/indications as they become available. The successful candidate will provide input to establish new processes, work instructions, and SOPs to ensure effective and efficient execution of clinical operations.
- Ensures the Operational plans/activities are executed and delivered with quality and on budget from study start up to Clinical Study Report finalization.
- Provides strategic as well as operational input into trials within Clinical Operations.
- Responsible for the overall operational aspects of development and delivery of study protocols, informed consents, study plans, quality initiatives, etc. needed to conduct trials within Medical Affairs.
- Manages and troubleshoots the Clinical studies from a compliance and standardization perspective
- Participate in selection process of CROs and provide territory-specific expertise for other projects as required.
- Responsible for assisting with strategic planning for site selection/evaluation, contract negotiations with vendors, patient recruitment programs, ensuring proper study conduct, and budget forecasting.
- Collaborates effectively with cross-functional management teams and external partners.
- Proactively identify and remediate study issues.
- Effectively collaborates with all of clinical operations colleagues for input and information exchange to ensure success of all studies/programs.
- Provide senior management with timely updates on progress and changes in scope, schedule, and resources within a study/across a program.
- Line management capabilities which includes providing guidance, performance development, coaching and mentoring, as the Clinical Operations group expands.
- Represents Clinical Operations as a member of the team and other cross-functional teams as appropriate.
- Works with Clinical Operations leadership to implement and refine the company's operations strategy as requested.
- Develop, review, update, and add SOPs as company/situations evolve when applicable.
- Develop and maintain professional relationships with opinion and thought leaders.
- Represent the company at meetings with external attendees.
- May directly or indirectly supervise employee(s) as needed.
Skills and Requirements:
- Bachelors/Masters degree (or equivalent) in a health care or other scientifically-related field.
- 8+ years of related industry experience as a CRA/Manager/Associate Director or related function with increasing responsibility and scope.
- Previous experience in the management/conduct of global clinical trials, particularly in regions specific to Our client' development plans.
- Oncology experience preferred.
- Experience in US/Ex-US Expanded Access Programs (EAPs) and Investigator Initiated Studies desired.
- Leadership skills; communicates and demonstrates vision and commitment.
- Effective influence and relationship management skills.
- Financial acumen in creating and managing large clinical program budgets.
- Builds successful collaborations with internal and external partners.
- Strong communication skills; verbal, written, and presentation.
- Highly motivated and enjoys working in a fast paced environment.
- Strong organizational skills and the ability to prioritize and multi-task.
- Possesses strategic thinking and proactive identification of issues.
- Positive, flexible, self-starter, able to multi-task, and thrives under pressure.
- Excellent judgment and problem solving skills.
- Flexible as it relates to responsibilities/assignments since Our client is a small company and job scope/role will inevitably evolve as the company grows and matures.
- Computer proficiency (MS Word, Excel, Powerpoint).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.