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. degree with therapeutic focus in rare/orphan, pediatric, metabolic and/or endocrinology
▪ 10-15 years of pharmaceutical/biotech experience in a leadership role in clinical drug development.
Our client is seeking an interim Medical Director/Sr. Director Clinical Development who will join the Clinical Development group and provide clinical scientific leadership for programs including direct responsibility for clinical development strategy and execution of clinical trials, with a focus in oncology. The optimal candidate will have the desire to proactively participate within a cross-functional team of internal clinical, regulatory, scientific and operational colleagues and have the ability to interact with external experts, investigators and government agencies. This role is instrumental in supporting the growth of portfolio and subsequent generation of new portfolio companies.
- MD (MD/PhD preferred)
- 7+ years clinical oncology experience in a pharmaceutical/biotech company
- Experience designing and executing first-in-human through registration-enabling clinical programs
- Technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies.
- Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment. Experience in developing effective relationships with key investigators
- Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process.
- Advanced knowledge of oncology is required
Our client seeks a Head of Pharmaceutical Development to lead and manage global activities for the development of commercializable pharmaceutical dosage forms. Their main emphasis is on solid controlled release dosage forms, which includes innovative formulation concepts, technologies and strategies, CMC Documentation, Product Development and Analytical/Bioanalytical methods development and testing, as well as IVIV correlation.
The Head of Pharmaceutical Development is responsible for internal specialty Pharma projects and client-sponsored projects from development of prototypes, manufacture of clinical supplies to commercial-scale process optimization and validation. In collaboration with peers, they contributes to the growth of the Company and lead business strategies with regard to scientific aspects, to focus on common goals and optimize organizational efficiency.
- Postgraduate Degree (M.Sc. or Ph. D, preferred), ideally in pharmacy or chemistry
- Minimum of 10-15 years’ experience in product development, in a pharmaceutical company combined with 5 years in a leadership role.
- Grasp of pharmaceutical operations, including tableting, particle coating, encapsulation, fluid bed operation and microencapsulation.
- Knowledge of cGMP’s, FDA, DEA and OSHA regulations
A well-funded, small biotech located in PA is looking for an Interim Senior Project Manager. The ideal candidate will be a highly qualified Project Manager who is well versed in drug development. This individual will create a road map, manage pharmacology/toxicology studies and subsequent data.
- Pre-IND workflow mapping and management
- Clinical program development
- Site-selection planning
Our client is seeking an interim Director of Program Management who will be responsible for driving multiple workstreams for the client’s rapidly growing portfolio. This person will be responsible for actively managing and integrating highly technical and cross functional teams which may include the project team, subteams, business due diligence team and joined teams with alliance partners to ensure the advancement of programs in a dynamic, highly collaborative environment. They will manage program scope, timelines, deliverables, budget, risks, decisions and alignment across the organization. The ideal candidate will have a strong scientific background and familiarity with early-stage drug development. In this highly visible role, they will be able to routinely flex between scientific / technical details and big-picture planning. They will have or be able to quickly develop a breadth and depth of expertise, spanning research through early clinical development unique to multiple therapeutic modalities, and will partner closely with many internal and external stakeholders.
Our client, a clinical stage company working on novel targeted therapeutics for oncology, is seeking an Interim Project Manager who 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 Project Manager 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. Qualifications include:
- 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
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.
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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