Director Level / International Travel / Expansive Remuneration
About the job
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with us means your everyday work improves patients’ lives around the world.
As an Executive Director of Clinical Development focusing on the General Medicine therapeutic area, you will oversee business aspects of clinical operations, project management and business development assistance for the General Medicine Business Unit to achieve target revenue and profitability while ensuring the contracted services and expectations of all projects are carried out by the project teams in accordance with executed contracts and Customers’ expectations. Duties include management of staff utilization and realization of project revenue for business unit (BU), analysis of financial data, assuming role of primary liaison with Customers, Vendors, Senior Management and Investigator sites as needed, and organizing department hierarchy and processes to achieve targets. May include line management responsibilities for project management and clinical staff within BU.
1. Provides oversight for all assigned BU projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfil all federal and local regulations.
2. Forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results.
3. Works with senior management and Business Development to set strategic direction for BU to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth.
4. Evaluates progress of BU projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines.
5. Actively manages and mentors Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. Ensures appropriate training and development is provided to all assigned staff.
6. As necessary, troubleshoots difficulties which may arise in project conduct between the company and Customer, and/or between Clinical Development. Facilitates team building and communication. Acts as a liaison and facilitator between other functional areas for overall operational issues.
7. Develops and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements.
Performs other work-related duties as assigned.
Desired Skills and Experience
Requires a BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. Must have spent some time actively managing clinical research projects across functional areas, and other relevant experience is advantageous. Previous supervisory experience and pharma/CRO experience is required. Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary. Must have demonstrated proficiency with ICH/GCP guidelines. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail is required. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment is essential. Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach. Must have valid, current driver’s license and ability to secure corporate credit card.