Dir, Project Delivery- Early Phase

Description

Director, Project Delivery

 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical  and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.    

Job responsibilities

• Serves as team leader; resources, line manages and mentors other project management staff.
• Provides oversight for all assigned projects to ensure study launch, conduct and closeout occur 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 fulfill all federal and local regulations.
• Forecasts, prioritizes, and directs staff to achieve on-time sponsor deliverables with quality and in accordance with contracted scope and Customer expectations.
• Collaborates with Therapeutic Strategy and Innovation team to provide operational input in support of proposal development and pricing—including the proposed operational strategy.
• Drives preparation and facilitation of bid defense meetings in collaboration with Therapeutic Strategy and Innovation team and Business Development.
• Provides oversight to project management teams in driving management of financial aspects of assigned projects—i.e., executed contracts, CNFs, change orders, forecasting, invoicing, etc.
• Actively mentors Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks.   
• As necessary, troubleshoots difficulties which may arise in project conduct between the company and Customer and manages escalations appropriately. Facilitates team building and communication.
• Acts as a liaison and facilitator between other functional areas for overall operational issues.  
• Develops and maintains knowledge of evolving trends related to therapeutic area, competitive landscape (e.g., standard of care) and drug development trends.
•  Provides support to teams in regularly and comprehensively assessing and mitigating risks on their projects to assure patient safety, data integrity and quality Project Delivery.
•  Participates in corporate initiatives and/or represents Project Management in regional or business activities.
• Participates in the project Risk Review meeting process.
• Liaises with Project Sponsors and teams to promote optimized application of project management disciplines and approaches within a fast-paced, high-tech environment.
• Shares lessons learned and best practices across programs, building relationships with key stakeholder’s cross-functionally, across all levels.
• Supports Change Management, including adjustments based on emerging business or technical opportunities and challenges.
• Maintains senior management-level relationships with Customers via routine meetings (e.g., 1:1’s with counterparts), governance meetings and other forums.

Qualifications

What we’re looking for

• 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.
• Comprehensive management skills and experience, including but not limited to short- and long-term planning, evaluation, directing, managing and motivating staff, marketing and financial management.
• Prior cross-functional project management experience within the clinical trial industry is required
• Pharma/CRO experience is required, to include client relationship management
• 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 (Outlook, Teams, Word, Excel, PowerPoint, etc.)
• Demonstrated ability to manage multiple tasks within a dynamic projectized matrix team environment is essential – all while assuring Project Delivery on time and with quality.
• Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach.

Get to know Syneos Health
.Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.