A pre-clinical stage biotechnology company building a proprietary pipeline in Oncology and Immunology is looking for an Interim Chief Medical Officer. This role will be expected to lead his or her team on the strategic design, cost, and operational aspects of the client’s clinical trials. The ideal candidate will have Oncology experience and will have developed drugs from beginning to end, from Phase I to approval. The company is headquartered in Philadelphia, PA.

  • Regulatory Agency Expertise
  • Clinical Trial Design & Operations
  • Passionate Team Leader
  • Investor & Board Interaction

A rare disease company based in New Jersey is looking for a Chief Medical Officer and Vice President, Clinical Development. This role will be responsible for developing and managing their product portfolio strategy to bring products to market in compliance with global requirements. This position provides strategic and technical guidance for both developmental and commercial assets, as well as coordination, support and contribution to other drug development activities. This position requires travel estimated at 20%.

  • Strong working knowledge of the FDA and other regulatory organizations (EU).
  • Strong working knowledge of GCPs, principles of ICH GCP, roles of the IRB/IEC sponsor/investigator, preparation of the clinical trial protocol, IB and clinical modules for FDA regulatory Phase I-III approvals.
  • M.D. Board certified in a clinical subspecialty with an active unrestricted license in US (or EU countries).
  • 10-15 years of pharmaceutical/biotech experience in a leadership role in clinical drug development.

A biopharmaceutical company developing phospholipid drug conjugates (PDCs) is looking for a Vice President Medical / Chief Medical Officer to join their team. The ideal candidate will have a mastery of the drug development process (especially early development and early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This role will oversee the design and implementation of early stage pre-clinical and clinical projects. He/she will ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.

  • Highly independent role; able to make decisions with minimal consultation.
  • M.D. with drug development experience is required.
  • Clinical or research experience (in a pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
  • Chemotherapeutic/cytotoxin experience is preferred.
  • Experience and desire with driving patient recruitment a must.
  • Ability to travel 25-30%.

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.

An established leader in sterile compounding located in Pennsylvania is looking for a Head of Operations to lead their development, implementation, and ongoing direction of effective ‘Human Drug Outsourcing Facility’ strategies (i.e., 503B Business Unit). This role reports to the CEO and manages all operations leadership staff within the 503B Business Unit on a daily basis providing guidance and direction.

  • 10-15 years of experience in regulated pharmaceutical and / or sterile compounding industries with demonstration of expert skills and successful results orientation in all phases of corporate leadership.
  • Experience in leading the ‘Business Unit’ functions from an operations perspective.
  • Excellent analytical, writing and presentation skills are required. Senior managerial experience within various hands-on corporate environments.
  • Demonstrated experience in the strategic design and implementation as well as management of cross functional business strategies.
  • Demonstrated knowledge of complex US Federal and State Regulations inclusive of Government Contracting requirements.
  • Degree in scientific discipline required (advanced degree preferred).
  • Regulatory Agency Interaction / Inspection experience preferred.

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 large pharma company that manufactures GMP grade gasses used in bronchodilator inhalation products like Advair is looking for an individual with highly qualified GMP expertise. The candidate must have a background in Quality, Materials Management, and Manufacturing Production Operations in order to help the client’s North Texas facility become GMP qualified in three months. This role will develop the SOPs to bring this facility up to standard.

  • 10+ years’ experience managing GMP manufacturing operations.
  • Strategic and tactical experience in executing QA/QC SOPs.
  • Must have hands on experience and be able to walk into the facility with immediate credibility.
  • Performs GAP analysis and training.
  • Travel to Texas is required but some work can be done remotely.

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
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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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