This position requires a highly motivated physician who has outstanding scientific vision, exceptional leadership ability, a demonstrated record of success, and significant appreciation and knowledge of all phases of drug development from preclinical through Phase IV trials. The Interim CMO will be responsible for developing strategic plans for the client’s product candidate portfolio to ensure development programs meet quality and safety standards required by medical and regulatory agencies.
- M.D. Internal Medicine (Licensed and Board Certified) or equivalent required.
- Minimum of 10 years’ drug development experience performing clinical research in either a pharmaceutical or biotech environment.
- Experience in the pharmaceutical industry with leadership roles in clinical development and medical affairs for Central Nervous System (CNS) disorders.
- Knowledge of relevant FDA regulations and experience interacting with FDA personnel and other health authorities is essential.
- Experience in translational medicine, clinical pharmacology, and early stage development is desirable.
- Thorough knowledge of clinical research concepts and practices, as well as GCP and ICH Guidelines.
- A team-builder management style and effective leadership, people management, and communication skills are essential. Must be willing and able to be “hands on.”
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.
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.
The Product Manager drives revenue growth and profit for assigned products, executes marketing plans, and collaborates with engineering to develop a robust product portfolio. The Product Manager works closely with the marketing director to develop a clear “mapping” of the markets, competition, customer needs, and market trends to help establish a strategic plan for the business. Utilizing this collective assessment, this role also develops and executes an annual marketing plan that ensures bookings, revenue, and margin targets are met.
- Must be able to access shared database with government programs and access all physical areas of the facility (U.S. Citizen or Permanent Resident of the U.S.).
- Bachelor’s degree in Marketing or related Business field required; an MBA or Engineering degree is also helpful.
- Minimum of 7 years of product marketing and related brand development experience is required.
- Marketing or technical experience in Biopharma upstream processing technologies or single use technologies highly desired.
- Demonstrated business acumen and analytical skills.
- Demonstrated proficiency in communication techniques in all forms and with most forms of media.
- Demonstrated ability to collaborate with peers, cross-functional teams, and executive team.
- Proficiency with related marketing and sales software, MS Office products, and social media. Experience with ERP systems also preferred.
- Able to conduct complex, important work under minimal supervision and with wide latitude for independent judgment.
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.
A clinical-stage biopharmaceutical company is looking for an Interim MSL to serve as a resource and scientific expert on disease state concepts as well as company initiatives (particularly to treat Cystic Fibrosis). This role will communicate clinical and health economic information internally as well as to healthcare professionals, including clinical trial investigators, academic physicians, and CF care multidisciplinary teams. The position will establish and build out sustainable relationships with Thought Leaders to expand needed research, advisory, and other collaborative opportunities.
- Biomedical sciences degree required.
- 5+ years Medical Affairs experience, including 2+ years field experience, within biotechnology or pharmaceutical industry required.
- Understands government and industry guidelines, regulations, laws, etc. for appropriate interactions with healthcare providers.
- Ability to complete goals within allotted timeframes and deliver high quality results under pressure.
- Ability to work in line within a multi-disciplinary environment, on national and regional levels.
- Knowledge and understanding of appropriate marketplace desired.
- Ability to use Microsoft Office programs and to work in a matrix environment.
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.
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