POSITION OVERVIEW:

The Project Manager is responsible for leading and coordinating cross-functional pharmaceutical R&D programs across the drug development lifecycle, from preclinical research through clinical development. This role serves as a central point of coordination among scientific, clinical, regulatory, quality, and operational stakeholders to ensure projects are executed on time, within scope, and within budget. The Project Manager drives project planning, risk management, resource alignment, and operational execution while supporting critical development milestones and regulatory objectives.

KEY RESPONSIBILITIES:

This list is not exhaustive and may be supplemented and changed as necessary.

• Develop, maintain, and manage detailed project plans, timelines, and operational roadmaps utilizing tools such as Microsoft Project, Smartsheet, or similar project management platforms.
• Drive project execution by monitoring deliverables, tracking milestones, and ensuring alignment with overall program objectives and development strategies.
• Lead cross-functional project meetings involving R&D, Clinical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and external partners as required.
• Facilitate communication and collaboration among stakeholders to ensure timely decision-making and effective project execution.
• Identify critical path activities, project dependencies, potential risks, and operational challenges that may impact project outcomes.
• Develop and implement risk mitigation strategies, contingency plans, and escalation processes to minimize delays and maintain project momentum.
• Monitor project budgets, forecast resource requirements, and support financial planning activities throughout the project lifecycle.
• Evaluate and manage project scope changes while assessing impacts to timelines, budgets, resources, and program objectives.
• Support preparation and coordination of regulatory submissions, including INDs, CTAs, and other development-related documentation.
• Partner with Regulatory Affairs and Quality teams to ensure compliance with applicable regulatory requirements, GMP standards, and internal quality systems.
• Develop project status reports, dashboards, and presentations for leadership and governance meetings.
• Maintain project documentation, decision logs, action item trackers, and governance records to support transparency and accountability.
• Coordinate cross-functional activities to ensure successful achievement of key development milestones and objectives.
• Drive continuous improvement in project management processes, tools, and best practices to enhance program execution and operational efficiency.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

QUALIFICATIONS AND REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related scientific discipline required.
• Advanced degree (MS, PhD, MBA, or equivalent) strongly preferred.

Experience

• Minimum of 5 years of experience within pharmaceutical, biotechnology, or life sciences organizations.
• At least 3 to 5 years of direct project or program management experience supporting research, development, clinical, or operational initiatives.
• Experience managing cross-functional teams and projects in a regulated environment.
• Experience supporting regulatory submissions and development programs is preferred.
• Demonstrated understanding of pharmaceutical product development, including preclinical, clinical, regulatory, and commercialization activities.

Knowledge, Skills, and Abilities

• Strong understanding of the drug development lifecycle from preclinical research through clinical development.
• Proven project planning, scheduling, budgeting, resource management, and execution capabilities.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong analytical and problem-solving skills with the ability to anticipate challenges and implement practical solutions.
• Excellent communication, presentation, facilitation, and stakeholder management skills.
• Ability to influence and drive alignment across cross-functional teams without direct authority.
• Experience utilizing project management tools such as Microsoft Project, Smartsheet, Planisware, or similar systems.
• Strong organizational skills with a high attention to detail and ability to maintain comprehensive project documentation.
• Self-starter with the ability to work independently while effectively collaborating across teams.
• PMP certification or formal project management training is a plus.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous paid time away program and company-paid holidays.

The expected salary range for this position is $120,000 to $140,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.