FEATURED

CAREER OPPORTUNITIES

The Chief Medical Officer will be instrumental in supporting the growth of the Company as it continues to advance the development of its novel anti-cancer agents. He/she is a key leadership position within the Company and is responsible for managing all of the clinical aspects of the business. The successful candidate will have hands-on responsibility for designing and executing clinical trials and will demonstrate a firm understanding of the needs for Phases 1 through 3. This position requires a leader who can generate and effectively implement all strategic initiatives and programs and communicate effectively to senior management.

  • Minimum of 15 years’ industry experience.
  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines.
  • Experience in Phase I – III programs leading to BLA filings.
  • MD or equivalent degree. Background in medicine, pharmacy, biology or other life sciences.

This role directs all regulatory activities for new and existing products to ensure alignment and compliance with FDA laws and guidances and local regulatory requirements, as well as Company policies. This role will develop and oversee the implementation of regulatory strategies in support of the Company’s development and marketed product programs. Additionally, this position will provide regulatory direction and support to ensure compliance in areas of advertising, promotion labeling, Chemistry, Manufacturing and Controls (CMC), and other activities related to the commercialization of US marketed products.

  • Bachelor and/or Advanced Degree in a scientific field with 12+ years in a Regulatory Affairs function within the pharmaceutical industry. CMC experience preferred.
  • Formulate, communicate and implement regulatory strategy for assigned programs to meet regulatory requirements and achieve established project milestones and Corporate objectives.
  • Support regulatory activities from development through post-approval, including; interfacing with regulatory authorities, preparation of regulatory documentation, critical review of regulatory dossiers and query response strategies and execution; oversight of labeling processes for marketed products; and oversight of regulatory guidance, review and submission of advertising and promotional materials.
  • Ensure that all plans and activities for and on behalf of the Company are carried out with the “best” industry practices and the highest ethical standards.

The Director, Quality Assurance is responsible for ensuring the Company’s Quality System, including implementation and maintenance, is in compliance with U.S. and other countries’ regulations/laws including adherence to GMP and GCP where we may market products as well as seek product approvals. Ensures that the Company’s Quality Systems are in compliance with applicable regulations.

  • Bachelor’s Degree in a science or relevant related field.
  • Minimum of 15 to 20 + years of experience in a Quality Assurance function within the medical products industry.
  • Experience with Quality Systems and direct experience with FDA audits for pharmaceutical products or related medical products.
  • Must be able to appropriately prioritize activities associated with timelines and risk management from a quality perspective.
  • Vendor management experience.
  • Experience working in a small company environment is preferable.

Reporting to the Chief Medical Officer, the Medical Director will be responsible for the ‘hands on’ development and implementation of clinical development activities. The Medical Director will provide leadership and policy direction to ensure the client meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials.

  • Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.
  • M.D. Board certified with relevant clinical experience in areas related to client programs.
  • 7+ plus years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
  • Clinical experience in rare diseases or therapeutic areas of interest preferred.

Located in NJ, the Product Manager will play a critical and central role in the final product definition and product launch process for the client’s digital/chemical indicator product line. The role has responsibility for the complete life cycle of the product including developing and executing go-to-market plans for all new products and services within this product platform. With accountability for market shaping ensuring products are launched into marketplace successfully, this role requires a combination of strong marketing skills, project/program management, consensus building, and the ability to coordinate resources from a variety of supporting teams. The Product Manager is also responsible for developing the business case and business model by talking to customers, learning the market, collaborating with executives and peers and collaborating with the Innovations team to develop and commercialize the product.

  • Greater than 9 years product marketing/product management experience with minimum of 5 years in a technical product category (RFID, bar code technology, asset tracking).
  • Expertise in project management cycles and deliverables for hi-tech products.
  • Knowledge of product and operational marketing, market studies, pricing, products, promotions, distribution and statistical tools.
  • Demonstrated management success in cross-functional collaboration.

Located in NJ, the Interim Product Manager plays a critical and central role in the final product definition and product launch process for the Company’s digital/chemical indicator product line. The role has responsibility for the complete life cycle of the product including developing and executing go-to-market plans for all new products and services within this product platform. With accountability for market shaping ensuring products are launched into marketplace successfully, this role requires a combination of strong marketing skills, project/program management, consensus building, and the ability to coordinate resources from a variety of supporting teams. The Product Manager is also responsible for developing the business case and business model by talking to customers, learning the market, collaborating with executives and peers and collaborating with the Innovations team to develop and commercialize the product.

  • Greater than 9 years product marketing/product management experience.
  • Successful product launch experience.
  • Expertise in project management cycles and deliverables for hi-tech products.
  • Knowledge of product and operational marketing, market studies, pricing, products, promotions, distribution and statistical tools.
  • Demonstrated management success in cross-functional collaboration.
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THESE ARE ONLY OUR FEATURED CAREERS

CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES

Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Suite 214
Wayne, PA 19087

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