Denver, CO

Vice President Project Management

OUR COMPANY

Aktivax is a Specialty Pharmaceutical company developing and commercializing drug products in a portfolio of proprietary prefilled delivery devices, emphasizing improved usability, safety and drug stability. Our highly scalable Specialty Pharma model is based on a minimal core internal development team, supported by consultants and manufacturing subcontractors. Our leading development program is an emergency auto-injector for medical countermeasure treatment.

We look to develop products and treatments that improve the lives of the communities we serve.Our mission is to bring peace of mind to individuals and their communities through the work we do.Our vision is to be recognized for our innovative solutions that care for patients and communities.Our values are Truth, Goodness, Caring and Perseverance.

OUR CULTURE

We emphasize a safe, inviting and inclusive culture.We are striving for a combination between a demanding and challenging work style and promoting a balanced life for our employees. We expect people to work hard, but we also encourage play (skiing on good snow days, meeting after work for pool, morning smoothies). We want you to bring your whole self to work. Our values are central to our culture and we believe that every position in this company will help lead us to greater innovation.

JOB PURPOSE

The Vice President of Project Management (VPPM) reports directly to the CEO and is primarily responsible for project management of drug-device combination products from inception to regulatory approval. The VPPM will be responsible for a range of projects from short term feasibility projects to multi-year product development programs with budgets ranging from sub $1MM up to multiple $10MM while applying the proper resources and priorities. The VPPM is a member of the company Leadership Team partnering hand in hand with the management team to ensure operational excellence in delivering high quality projects on time.

RESPONSIBILITIES AND DUTIES
* Manage a team of project managers, CMC, and Regulatory managers
* Be responsible for driving project execution and monitoring technical, development and regulatory progress and budgets and providing the resources for 4-10 large product development projects
* Coordinate project status, milestones, risks, and expectations with the VP Product Development.
* Generate reports including technical progress, budgets, and expenses, earned value, and risks.
* Responsible for project coordination and reporting with Government sponsors and pharmaceutical partners
* Support contract and grant proposal preparation
* Works cross functionally with the VP of Product Development in order to deliver products to market efficiently with high quality standards that enable the company to meet its mission to deliver peace of mind

QUALIFICATIONS
* Bachelors Degree in related field
* Over 10 years of experience in biotech/pharma industry
* Comprehensive project management experience
* Has been involved at a leadership level taking more than one drug to FDA approval
* Significant experience with both drug development and the U.S. regulatory process - beneficial to have some experience with ex-U.S. regulatory processes
* 15 years of experience leading project managers and project management teams
* Excellent verbal and written communication skills
* Excellent organizational skills and attention to detail
* Excellent time management skills with a proven ability to meet deadlines
* Ability to function well in a high-paced and at times stressful environment with shifting priorities
* Engage with the team, and represent the company externally in a manner that represent the company culture

PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the 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 frequently required to:
* Stand, bend, sit, talk, hear, and use hands and fingers, handle or feel; reach with hands and arms; and talk and hear.
* Specific vision abilities required by this job include close vision requirements due to computer work
* Light to moderate lifting is required
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