Pharma/biotech company with clinical stage innovative medicines. Will oversee some of the medical affairs activities of the therapeutic area, along with the Chief Medical Officer. Company areas of focus include a range of therapeutic franchises such as rare disease specialty areas. The company’s core strengths include regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities.
- Will develop, review and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV, IIS projects, etc.) at the regional/local level.
- All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
- Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to company conduct on clinical studies.
- May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
- May assist in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
- May represent the medical function on cross-functional integrated teams for medical affairs ‘activities. May represent company at external meetings including investigator meetings, scientific association meetings, etc.
- May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
- May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
- Future responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
- MD with experience in Oncology preferred, PhD with Oncology experience.
- Board eligible or certified Oncologist a plus.
- Minimum 2-3 years in pharmaceutical industry for the Associate Director level, minimum of 3-6 years of experience for the Director level, with most in Medical Affairs, but some clinical trials/research experience a plus.
- Experience in presenting and publishing scientific information a plus.
- Knowledge of clinical trial design, biostatistics desired.
up to $320K + plus Annual Bonus + Stock OptionsLong Term Incentives
New Jersey/PA/NY/CT Area
No, not at this time.