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CAREER OPPORTUNITIES

Directs the staff and programs of the organization’s pre-clinical development programs leading to successful Investigational New Drug (IND) filing(s). Works closely with CRO staff, department directors, CRO networks, and physicians to ensure that the highest standards of quality and service are instituted and maintained through the pre-clinical development process. Part of Executive Team and will interact directly with Management and the Board of Directors. Will lead discussions with regulatory agencies in order to progress approval pathways. Manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. Comprehensive knowledge of the overall pre-clinical development process leading to successful IND filings and NDA acceptance.

  • CSO or similar experience for 10+ years.
  • Comprehensive Drug Discovery program experience.
  • Experience working with the FDA related to IND filing(s).
  • Rare, orphan, and cannabinoid experience is preferential.
  • Experience working in small, start-up life science organizations.
  • Excellent communication, both verbal and written, with a keen eye for detail is required.
  • Flexibility, adaptability, and excellent judgment is required.
  • This position is located in Doylestown, PA – remote is OK.

An early stage biotech research and development company is in need of a Chief Executive Officer (CEO). The CEO is responsible for providing strategic leadership for the company by working with the management team to establish strategies, plans, and policies. The CEO will make a significant contribution to business development, the monetization of existing IP and development of new IP, setting corporate culture, and the overall growth of the organization.

  • An undergraduate degree in the Sciences or Business is required, with an advanced degree (MBA, MD, PhD, etc.) highly preferred.
  • The ideal candidate will have 20+ years pharma experience – including executive leadership – within both the corporate and “start-up” sectors. Public company experience is preferred.
  • Have an extensive network, including C-level contacts, to forge new Business Development relationships with companies operating in the LSD space (e.g., Sanofi, Takada, GSK, Alexion, etc.).
  • Experience in rare diseases, especially in the area of LSDs, is highly preferred.
  • A proven track record of working effectively with his/her Board of Directors/management and be a highly disciplined communicator with all stakeholders including investors, customers, strategic partners, and employees.
  • A strong understanding of the science is preferred.

A privately held, clinical stage biopharma is looking for a Chief Executive Officer (CEO). The CEO is responsible for providing strategic leadership for the company by working with the Board and other management to establish strategies, plans, and policies. The CEO will make a significant contribution to business development, the monetization of existing IP and development of new IP, setting the corporate culture, and the overall growth of the organization.

  • An undergraduate degree in the Sciences or Business is required, with an advanced degree (MBA, MD, PhD, etc.) highly preferred.
  • The ideal candidate will have 20+ years pharma experience – including executive leadership – within both the corporate and “start-up” sectors. Public company experience is preferred.
  • A proven track record of working effectively with his/her Board of Directors and being a highly disciplined communicator with all stakeholders including customers, strategic partners, and employees.
  • Experience with corporate governance.
  • Ability to build consensus and relationships among executives, partners, and the workforce. Encourage employee engagement.
  • Have an extensive network, including C-level contacts, to forge new Business Development relationships in existing and new markets.
  • A high level of personal skills is required to make formal, persuasive presentations to groups and to deal effectively with the Board, investors, and internal personnel.
  • Proven ability to successfully negotiate projects, licenses, and transactions with pharmaceutical counterparties.

A cancer diagnostic solutions company in the U.S. is looking for a Senior Vice President Medical. This role will be responsible for all aspects of the company’s medical and clinical strategy and implementation of that strategy for products and services. The SVP Medical will lead and manage the Clinical Operations team in Research & Development. A key role will be to partner with multiple functions and to create the strategies for the clinical trials portfolio. This individual will drive project excellence and ensure that cost, quality, and timeliness of programs align with corporate plans and established goals, striving for continuous improvement and operational efficiency.

  • M.D. required.
  • At least 10+ plus years in clinical development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
  • Clinical experience in diagnostic products preferred.
  • Strong working knowledge of the FDA and other regulatory organizations.
  • Ability and desire to work collaboratively with senior scientific and business leaders to execute near- and long-term plans and to adapt to rapidly changing business conditions.
  • Ability to manage multiple clinical trials at different stages in several programs as required.

A specialty pharmaceutical company is seeking a highly motivated individual to join them as Head of CMC.  The role will report directly to the Chief Medical Officer and will be the strategic and technical lead for all small molecule pharmaceutical development related activities, including drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical development and quality control, supply of clinical trial materials and logistics, and support of regulatory CMC.

  • The position requires a degree in Chemistry, Pharmaceutical Science, Chemical Engineering, or related field and a minimum fifteen years of small molecule CMC development experience in a pharmaceutical or biotechnology CMC/cGMP environment. Advanced degree preferred.
  • Substantial experience implementing technical, strategic, and operational plans with projects in clinical development, e.g. Phase 1 through Phase 3 and commercialization and solid understanding of all facets and phases of CMC drug development.
  • Experience overseeing Contract Manufacturing and Contract Development Organizations, including project management and providing technical solutions, is required.
  • Demonstrated understanding of research, technical development, GMP Manufacturing, Quality, Supply Chain, Regulatory, Clinical, and Product Strategy functions and the interdependencies of those functions.
  • Experience managing a team and a proven track record of moving drug candidates from early phase development to commercial launches is required.

This position will be responsible for leading and managing all of the company’s QA programs, activities, and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and regulations. The incumbent will report directly to the Chief Compliance Officer to plan and coordinate all necessary QA activities. She/He will be responsible for providing compliance oversight of all contractors/manufacturers and will have the ultimate authority for disposition of commercial products.

  • Bachelor’s Degree in a life science-related discipline required.
  • Advanced degree (PharmD or PhD) preferred.
  • Certified Auditor.
  • 20+ years of experience in the pharmaceutical/biotechnology industry.
  • Minimum 15 years’ senior quality systems leadership in the pharmaceutical industry.
  • High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions.
  • Ability to build and manage relationships with business partners.
  • Strong, proven, hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry.
  • Previous experience with building QA systems and company-wide SOP system.
  • Extensive experience handling FDA inspections required.
  • Proven ability to interpret regulations and to define and communicate strategy/plan to teams across multiple programs.
  • Experience with multiple aspects of product development (CMC, nonclinical and clinical).
  • Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements.

This position will be responsible for leading and managing all of the company’s QA programs, activities, and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and regulations. The incumbent will report directly to the Chief Compliance Officer to plan and coordinate all necessary QA activities. She/He will be responsible for providing compliance oversight of all contractors/manufacturers and will have the ultimate authority for disposition of commercial products.

  • Bachelor’s Degree in a life science-related discipline required.
  • Advanced degree (PharmD or PhD) preferred.
  • Certified Auditor.
  • 20+ years of experience in the pharmaceutical/biotechnology industry.
  • Minimum 15 years’ senior quality systems leadership in the pharmaceutical industry.
  • High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions.
  • Ability to build and manage relationships with business partners.
  • Strong, proven, hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry.
  • Previous experience with building QA systems and company-wide SOP system.
  • Extensive experience handling FDA inspections required.
  • Proven ability to interpret regulations and to define and communicate strategy/plan to teams across multiple programs.
  • Experience with multiple aspects of product development (CMC, nonclinical and clinical).
  • Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements.

A rare disease company is looking for a Regulatory Affairs Leader to lead and manage the regulatory functions and activities related to new and existing products, on a domestic and/or international basis as required by the Company and its affiliates. Ensures the implementation of the registration strategies for the Company, in line with business objectives and priorities and in compliance with regulatory requirements. Supports efforts to obtain world-wide approvals to market our products. Operates as a key stakeholder in the Company’s regulatory activities and initiatives accountable to ensure the quality of the Company’s records, products and processes. Participates as a key member of project teams responsible for lifecycle management and pipeline development programs.

  • Bachelor’s degree or equivalent required; advanced degree in the life sciences strongly preferred.
  • Must have at least ten (10) years of experience in Regulatory Affairs, with at least two (2) years of experience working with Regulatory strategy.
  • Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs, and other major regulatory submissions.
  • Experience in a commercial-stage organization required.
  • Prior experience with outsourced functions and managing contract employees preferred.
  • Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.
  • This position is based in Lebanon, NJ.
  • Limited travel; approximately 20% on average; depending on business need.

A life sciences company with over 35 years of active pharmaceutical ingredient development and manufacturing expertise is looking for a Senior Project Manager, who will be responsible for liaising between the client and customers, providing overall project leadership for new product development opportunities.

  • Bachelor’s degree in Chemistry or Chemical Engineering required. Advanced degree strongly preferred.
  • 6-8 years of experience in the pharmaceutical arena, with Technology Transfer experience, and familiarity with cGMP regulations.
  • Experience with overall management and responsibility for new product development project teams.
  • Previous experience with direct customer contact and relationship management with excellent communication skills.
  • Skills managing multi-disciplinary teams and motivating others using influence.
  • Strong project management skills and high level of attentiveness to detail.
  • Location: Midwest

The Project Manager (PM) has overall responsibility for the successful initiation, planning, design, execution, monitoring and closure of clinical trial project efforts. The PM collaborates with internal teams to onboard new contracts and actively manage the scope of work and budget during the project lifespan. This role will establish and oversee project plans with detailed timelines by working with cross functional teams, defining roles and responsibilities, setting deliverables, and managing internal activities from initiation to completion.

  • Bachelor’s degree in a science-related field required; Master’s degree or PMP certification a plus.
  • 7+ years of relevant program/project management experience required.
  • Strong project management and communication skills with ability to work with internal stakeholders and external sponsors during project onboarding, launch, maintenance, and closeout.
  • A working knowledge of the pharma or biotechnology industry and the peculiarities of clinical trial operations is a plus.

The Principal Scientist Pharmacology in the Translational Sciences group will report to the Executive Director of Research. This position will be a key member of the team and will partner with internal team leaders and external partners to develop and implement research on Translational Read-Through-Inducing Drug (TRID) programs. The ideal candidate will have a fundamental understanding and strong perspective of genetics, functional translational read through, pharmacology, and experience as a contributing member of several pharmacology programs, with minimal supervision, from research/discovery to candidate selection.

  • PhD in, Molecular Biology, Pharmacology, or related field required.
  • 6-8 years of industry experience in in vitro/in vivo pharmacology (experience working in a fast paced, small biotech environment is essential).
  • Experience developing cell-based models of human disease. Including, but not limited to, primary cell assays, iPSCs, CRISPR generated cells, and organoids.
  • Project leadership experience of successfully taking small molecules from early stage discovery to development decisions.
  • Extensive knowledge in functional translational read-through and pharmacology.
  • Experience working with CROs is essential.
  • Experience in developing robust biological assays and decision-enabling experiments.
  • Outstanding written and oral communication skills are essential.

Our client is a privately held biopharmaceutical company located in Chester, NJ. The company is working to develop new drugs and new, safer, and more effective ways to deliver therapies to treat cancer. They are led by a management team with extensive experience in all phases of pharmaceutical product development and clinical research. While the company’s current focus is in oncology, early stage research has also shown that its platform technology could be applied to other diseases. The candidate can work remotely with travel to the office as needed.

  • Initially, the job will require 5 – 10 hours per week, ramping up to further hours per week in the future.
  • Reports to the CEO.
  • A cancer drug biologist is preferred.
  • Small molecule, gene therapy, and peptide experience are preferred.
  • 15+ years of industry experience in drug and pre-clinical development.
  • Multiple therapeutic areas such as oncology (experience in SCLC, TNBC, metastatic soft tissue sarcoma preferred), hematology, and rare diseases.
  • Has experience from pre-clinical to post market commercialization.
  • Experience in being part of an IND submission.
  • Someone with a commercial perspective rather than an academic perspective is required.
  • Drug Delivery experience would be a nice to have.
  • Experience interacting with regulatory agencies.
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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.
314 S. Henderson Rd.
Suite G370
King of Prussia, PA 19406

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