Project Manager

Work Schedule

Environmental Conditions

Job Description

Project Manager

We are seeking an experienced and strategic Project Manager to lead cross-functional teams in the execution of pharmaceutical development and commercialization projects. The successful candidate will be responsible for managing complex programs across drug discovery clinical development regulatory submission and manufacturing scale-up. This role requires a strong understanding of the pharmaceutical development lifecycle regulatory requirements (FDA EMA) and project management methodologies.

Key Responsibilities:

Project Leadership: Lead the planning execution and delivery of drug development projects from preclinical through commercialization phases.

Cross-functional Coordination: Manage multidisciplinary teams including Clinical Regulatory CMC QA and Commercial to ensure alignment on project goals and deliverables.

Timeline and Budget Management: Develop and track detailed project plans timelines resource allocations and budgets. Identify and mitigate risks proactively.

Stakeholder Communication: Provide regular updates to senior leadership and project sponsors. Facilitate decision-making through status reports dashboards and governance presentations.

Regulatory Support: Coordinate with Regulatory Affairs to ensure timely preparation and submission of INDs NDAs MAAs and other key filings.

Vendor Oversight: Manage third-party partners and CROs to ensure contract deliverables milestones and quality standards are met.

Change Management: Lead change control processes and project re-alignment as business or scientific priorities evolve.

Compliance and Quality: Ensure all activities are conducted in accordance with GxP standards and relevant regulations.

Qualifications:

Education: Bachelors degree in Life Sciences Pharmacy Chemistry or related field required. Advanced degree (MBA MS PhD PharmD) preferred.

Experience:

8 years of project management experience in the pharmaceutical or biotechnology industry.

Proven track record of leading complex development projects ideally including clinical stage or commercial programs.

Experience with global regulatory submissions and working in a matrix environment.

Certifications: PMP certification or equivalent preferred.

Skills:

Strong knowledge of drug development processes and regulatory frameworks (FDA EMA ICH).

Excellent communication leadership and stakeholder management skills.

Proficiency in project management tools (e.g. MS Project Smartsheet Primavera).

Ability to lead under pressure and handle multiple priorities with agility.

Key Competencies:

Strategic thinking with a strong execution mindset

Collaborative leadership style with influence across teams

Analytical and problem-solving abilities

Adaptability in a fast-paced evolving environment

Preferred Experience (Nice to Have):

Experience with biologics biosimilars or advanced therapies (e.g. cell/gene therapy)

Familiarity with Agile or hybrid project methodologies

Global project management experience