Director Program Management

Proclinical is currently recruiting for a Director of Program Management for a biotechnology company located in New York, NY. Successful candidate will be responsible for the operational execution for the company's Early Discovery and CMC programs.

Job Responsibilities:

• Contribute to program strategy, risk assessment, scenario planning and facilitating rapid and informed decision-making.
• Responsible for the operational execution for the company's Early Discovery and CMC programs.
• Ensure seamless integration of operational activities and scientific imperatives to ensure execution, scientific excellence and delivery of programs within time, cost and quality parameters.
• Responsible for the operations and completion of projects to meet the company's objectives and in accordance with highest standards of quality, data integrity and compliance.
• Ensure alignment across all internal and external contracted parties responsible for study conduct.
• Provide operational leadership on project teams and subteams.
• Develop and maintain constructive working relationships with internal and external team members and respective project managers at granting organizations (e.g. DOD and CARB-X)
• Contributes to developing and implementing publication plans for key programs in collaboration with cross-functional teams
• Attend weekly and monthly meetings and prepare agendas and summaries for these meetings.
• Work with the ED of PM to establish timelines that align with project team goals.
• Utilize standard PM tools to facilitate and enable rapid and informed decision making (e.g. Gantt charts, decision trees, scenario planning, risk assessment, Action/Decision tracking).

Skills and Requirements:

• BS or Advanced degree (Master's, PharmD, PhD) preferably in life sciences/health-related
• 10+ years of pharmaceuticals/biotech experience, including at least 7+ years drug development experience in the pharmaceutical, biotech setting; Early (pre-IND) drug development experience desired. Biologics drug development experience desired.
• Demonstrated ability to plan, execute and complete complex programs.
• Demonstrated ability to successfully lead teams
• Prior drug development experience (preferably with biologics)
• Excellent verbal and written communication skills
• Advanced organizational and/or project management skills
• Familiarity with general principles of GLP, GCP, GMP and ICH.
• Willing and able to be "hands on", doing the day to day activities to build programs
• Experience in the compilation of an IND, BLA, NDA and/or MAA.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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