Global Clinical Project Leader

Regulatory Jobs; New Haven (CT); On-site; USD 177,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid holidays

Vacation & sick days

Job summary

Celldex is seeking a Global Clinical Project Leader to manage clinical trial execution, develop the operational portion of the development plan, and lead cross-functional teams across trial management, data management, and program strategy. The role emphasizes risk-based management, timely program information, and continuous improvement in development operations.

The candidate should bring 8+ years in pharma/biotech with strong project management, GCP knowledge, and experience in

Qualifications

• BS degree or equivalent with 8+ years pharma/biotech experience; or MS with 6+ years, 2+ in Senior Clinical Trial Manager or similar.
• Experience planning and managing complex clinical programs.
• Dermatology and Allergy experience preferred.
• Technology aptitude including project management, eTMF, etc.
• Experience with data review, analysis and interpretation.

Responsibilities

• Develop and deliver the operational component of the clinical development plan.
• Oversee matrix relationships with Clinical Trial Managers and Data Managers.
• Represent development operations in cross-functional strategy meetings.
• Detect operational risks and develop mitigation plans.
• Provide timely information on the program and foster continuous improvement.
• Stay abreast of clinical operations developments and advise on strategy.

Skills

GCP knowledge

Project management

Data analysis

Communication

Interpersonal skills

Influence without authority

Dermatology/Allergy experience

MS Excel

Cross-cultural collaboration

Rapid adaptation

Education

BS or MS in life sciences

Tools

eTMF

Project management tools

MS Office

Job description

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

Overview

The Global Clinical Project Leader will provide overarching management of clinical trial execution for the assigned clinical development program. The incumbent will be responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program. The incumbent will be responsible for employing risk-based management strategies, implementing solutions, and providing accurate and timely information on the program and fostering continuous improvement in clinical development.

Responsibilities

• Develop and deliver on operational component of the clinical development plan in consultation with key stakeholders, including:
  • High level resource planning
  • High level budget oversight
  • Clinical drug supply requirements
  • Development of clinical program standards; and
  • Assessing impact of any proposed changes to the program
• Oversee matrix relationship with assigned Clinical trial Managers, Data Managers, and other members of the Clinical Project Team; ensure consistent execution across the program, deliver a development package of adequate quality for product registration.
• Represent development operations in cross-functional strategy and program team meetings.
• Detect possible operational issues/risks in the clinical development programs and assist CTMs in developing mitigation plans. Propose and implement solutions to issues/risks.
• Provide accurate and timely information on the program.
• Facilitate continuous improvement in clinical development.
• Stay abreast of clinical operations developments, methods, and technologies related to the biotechnology/pharmaceutical industry. Make strategic and tactical recommendations to provide and ensure competitive advantage to the company.
• Other job-related duties as assigned.

Qualifications

• Completed BS degree or equivalent, with a minimum of 8 years pharmaceutical or biotechnology industry experience; or completed MS degree or equivalent with a minimum of 6 years pharmaceutical or biotechnology industry experience, at least 2 of which must have been at the Senior Clinical Trial Manager or equivalent position.
• Planning and managing complex and/or strategic priority clinical programs.
• Dermatology and Allergy experience preferred.
• Technology aptitude (project management, eTMF, etc.)
• Experience with data review, analysis, and interpretation of data.
• In-depth knowledge of the drug development and commercialization process (from protocol writing to medical results reporting and submissions.)
• In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations.
• Proven people management expertise.
• Ability to effectively influence without hierarchical authority.
• Flexibility and drive for results - willingness to embrace change and be able to work in a changing environment while being driven to achieve goals.
• Strong communication skills to ensure that project plans and status are transparent, and that risks, issues and results are clear to all parties involved.
• Strength and depth of skills in gathering information for decision-making; negotiation; and communicating decisions and actions.
• Able to work both independently and collaboratively across cultures and geographies.
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook.
• Ability to work within established timelines, in a fast-paced environment.
• Excellent organizational and priority management skills.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.

Compensation

The expected base salary range for this position is $176,659 to $229,427We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.