Project Management Leader | Novel Gene Therapies | Innovative Biotech | NYC/NJ
Our client is an exciting, innovative, and rapidly-growing biotech company that focuses on developing novel “first-in-class” gene and cell therapy treatments for life-threatening rare diseases. This is a newly-created role where you will lead the cross-functional management, plan, and execution of projects in drug development (pre-IND to late-stage) toward commercialization of the Company’s programs.
This is a very exciting time within the organization as they are growing across a number of departments, and this is a great opportunity to join an exciting company at the early stage in its growth and have the ability to truly impact the organization and its success. This company has been attracting experienced and talented industry professionals and offers a small team comradery and fast-paced/collaborative work environment, while also having a diverse development pipeline and a proven leadership team.
Attractive Features about this Company & Opportunity:
- New “Ground Floor” Opportunity: This is a very important and impactful new position (due to growth) where you will have the ability to truly impact the organization (unlike in Big Pharma).
- Exciting Biotech Culture: The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team comradery, impact, nimble, quick decision-making, autonomy, minimal layers/bureaucracy) which fosters more collaboration, communication and swifter decision making (i.e. emphasis on progress and moving things forward).
- Great Time to Join: This is an exciting time to join this exciting high-growth biotech company, as they are progressing with multiple compounds and starting to expand/build out their teams.
- Impact & Visibility: You will report into a very highly-regarded VP Clinical Operations (with whom we have a longstanding relationship) and work directly with other Functional Heads and Executive Leadership.
- Cutting-Edge Gene Therapies & Novel Technology: Leveraged by its unique technology and cutting-edge science, this company is on the forefront of a novel approach to cell/gene therapy treatments, opening up a vast domain for discovering innovative new medicines. A handful of their compounds have recently been granted “Fast-Track” designation.
- Ability to Make a Real Difference: As opposed to being a small fish in a big pond in Big Pharma, you will work in a lean, entrepreneurial and collaborative environment where you will have the autonomy and visibility to make a significant impact on the company’s success, as well as in the lives of patients suffering from devastating rare diseases.
- Lead cross-functional teams, plan and execute a fully integrated CMC & program plans (Pre-Candidate Nomination to IND to Phase I/II/III) for development and commercialization of the Company’s gene therapy programs.
- Establish clear scope of work, lead the delivery of project milestones on time and within scope through utilization of project management standards.
- Coordinate and track status of cross-functional communication and integration activities.
- Establish project team framework for Core, Clinical and CMC teams and help define team charters, roles and responsibilities and key deliverables for each team.
- Manage vendors and successfully transfer viral vector production technology to ensure timely supply of Toxicology and clinical trial material to meet regulatory and commercial deadlines.
- Support planning, budgeting, integrating, tracking and communicating cross-functional activities for the Company’s product development programs. This will include working with internal stakeholders, academic partners and the Company’s designated Contract Manufacturing Organizations (CMOs).
- Lead the planning and execution of tech transfers, risk management, qualification, validation, resource allocation, and training.
- Monitor and control the execution of the plans through their lifecycle while identifying and communicating issues and risks and developing mitigation plans.
- Facilitate problem-solving, contingency planning, and decision-making.
Education & Desired Experience:
- An advanced degree (Masters or PhD) in Biological Sciences, Bioengineering, Chemistry, or associated discipline. PMP Certification and/or relevant additional training is a plus.
- 6+ years of relevant project management experience at a pharmaceutical and/or biotech company.
- Track record of leading and advancing projects from Discovery into Clinic including experience with IND and BLA filings.
- Experience in tech transfers, manufacturing, quality systems, CMO management, regulatory requirements, and commercial development.
- Experience managing CMO/CTO relationships and projects.
Brian Skurka, Partner
firstname.lastname@example.org - P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Drive
Parsippany, NJ 07054
Keywords: Project Manager, Director Project Management, rare diseases, gene cell therapy, orphan drugs