Our Client is seeking a Director of Program Management, to lead cross-functional teams accountable for the development strategy and seamless execution of innovative oncology drug candidates, with focus on regulatory applications.
This position requires the ability to:
• Lead cross-functional teams to develop, drive, adapt integrated product plans for
various innovative oncology programs.
• Own and drive cross-functional team performance to deliver agreed corporate goals
for the assigned project(s).
• Work closely to influence, advise and coordinate operational efforts across all key
functional areas to ensure alignment to plans and seamless execution.
• Drive issue identification and resolution, risk management and contingency planning.
• Advance functional and organizational excellence through creative thinking and
consistent willingness to stretch beyond normal operations.
• Advanced degree in pharmaceutical science, medicine, or another scientific discipline related to drug development is required with a minimum of 10 years of relevant experience in biopharmaceutical industry drug development.
• Demonstrated experience leading cross-functional teams in global product development, including regulatory filings (INDs, BLAs/NDAs, sBLAs/sNDAs).
• Experience in oncology drug development is required.
• Strong leadership and communication skills (including presentation skills) with success
in influencing all levels cross-functionally.
The Project Manager (PM) will be responsible for the integration of strategy into the development plan(s) and will provide operational leadership by working with cross functional teams.
Additionally, the PM will monitor and control the execution of the plans while identifying and communicating issues and risks and developing mitigation plans. The PM will support the planning, scheduling, tracking, and reporting of activities and milestones of the drug development programs. S/he will also provide scenario planning to support robust decision making through in-depth analysis of program activities.
- Bachelor’s degree (Master’s degree or PhD preferred)
- Pharmaceutical industry experience (preferred)
- Knowledge of multi-disciplinary biopharmaceutical drug development (research, pre-clinical, clinical, commercial)
- Risk, budget, and resource management expertise
- Knowledge of MS-Office applications required (including Word, PowerPoint, Excel, and Project)
- Lead process to clarify with stakeholders.
- Identify data sources, how to collect and prioritize.
- Process/Clean data.
- Integrate and store data.
- Look for correlation/trends/relation between data sets that allows for improved diagnosis, to measure treatment success, to refine therapies, etc.
- Use of machine learning, statistical modeling, and artificial intelligence.
- Measure and improve.
- Communicate actionable insights.
- Utilizes statistical software programs (e.g., SAS, R) to implement advanced statistical methodologies (e.g., longitudinal data analysis, survival analysis, Poisson regression, imputation methodologies and analyses with missing data) and verify underlying distributional assumptions
- Prior experience in biological sciences, pharmaceuticals, medical devices in entrepreneurial environment.
- A minimum of eight (8) years of experience conducting statistical analysis for clinical research projects.
Master’s or higher level degree in biostatistics, statistics, or a related field is required.
- Excellent verbal and written communication and interpersonal skills>
- Must be a self-starter, able to work independently and have the ability to coordinate multiple activities simultaneously in support of various projects
Our Client, an orthotics company, is seeking a VP Operations responsible for managing the supply chain for footwear products and 3rd party footwear sold throughout the company. Responsibilities include managing the relationship with key Asian and North American footwear suppliers and a 3rd Party Logistics (3PL) partner. This position will collaborate with peers to achieve company revenue, EBITDA and cash flow budget commitments. Successful candidates will possess deep understanding of offshore purchasing and supply chain management and be able to think strategically, identify problems/threats, analyze risk and assess outcomes related to potential solutions. They also must possess exceptional communication, collaboration, and negotiation skills to effect change and to build effective working relationships with both internal and external constituencies.
EXPERIENCE AND CAPABILITIES:
• Five to ten years’ experience sourcing products from suppliers located in China and managing an international supply chain.
• Executive experience cultivating and managing relationships with senior officials from Asian and North American suppliers
• 3PL warehousing and logistics management experience.
• Purchasing function leadership experience
• Project management experience
• Ownership for sourcing products from international contract suppliers made to company design specifications, including owning the design and quality assurance of the sourced products.
• Strong business systems understanding (ERP, CRM, PBX)
• Advanced Microsoft Office skills and system knowledge
• Footwear industry experience is preferred.
Our client is seeking an Interim Head of Regulatory Affairs who will be accountable for driving and overseeing global regulatory activities for all programs, both pre-clinical and clinical. This role will require direct hands-on contributions, as well as oversight of the growth and supervision of the regulatory function. S/he will be a senior member of the R&D Leadership Team and work closely with other members of the company leadership to support a high-performing cross-functional team. As such, the successful candidate must have significant experience in all phases of drug development with a track record of achieving successful regulatory milestones. Expertise in oncology therapeutics is required.
THESE ARE ONLY OUR FEATURED CAREERS
CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES
Phone: (610) 725-0290
Fax: (610) 975-0291
Ashton Tweed, Ltd.
314 S. Henderson Rd.
King of Prussia, PA 19406