Global Safety Medical Director for a worldwide biotechnology company located in California. Several positions are immediately available.
Leads and directs assessments of the benefits/risks for company products in early and/or late stage clinical development. Manages responses to regulatory inquiries, approving and submitting responses as required. Manages product safety reviews execution. Plans and develops strategy, reviews and signs-off of clinical safety documents including PSURs and ASRs, CSRs ICFs, and safety monitoring plans and investigator brochures. Identifies and communicates of potential safety signals of Pharmacovigliance activities. Responsible for regulatory inspection readiness within the group. Requires MD or DO or international equivalent with management experience. Board eligible/board certified is preferred. Previous safety experience in pharmacovigliance and clinical risk management in the pharma industry.
Compensation: base to 225K plus bonus and stock options.
Clinical Research Medical Director, Oncology for a
worldwide biotechnology company located in Southern Calif. The
company discovers, develops, and delivers therapeutics in the
area of cancer, kidney disease, rheuematoid arthritis,
Osteoporosis and cardiovascular disease. This position will
focus on Oncology drug development and will develop and
implement medical strategies and provide medical input for
clinical development programs.
Develops and manages key external and internal relationships.
Delivers scientific presentations at advisory boards and key
external scientific meetings. Authors clinical study reports,
publications and regulatory submissions. Designs and initiates
study protocols in compliance with project plans, federal
regulations, GCPs and good medical practices.
Requires MD and 2 or more years of clinical research and/or
basic science experience with clinical teaching and patient care
experience involving Oncology therapeutics. Must be board
certified or eligible in an appropriate medical disciipline.
Five or more years of clinical research experience in Oncology
combined with clinical teaching and patient care is desired.
Knowledge pf GCOP, FDA and EMEA regulations and guidelines aned
international requirements.
Compensation: to 250K plus bonus and stock options.
Medical Science Liaison (MSL), Oncology for a worldwide
healthcare company and leader in the development and marketing
of speciality pharmaceuticals. This position is field based and
will support the company's Oncology franchise for both marketed
and development products. Openings are currently available in
the Northeast, New England, Southeast, Southwest and Midwest.
Will be responsible for serving as the technical advisor between
the company and the medical community through the dissemination,
clarification and education of scientific data. Build long-term
strategic relationships with key physicians and investigators at
major academic and medical centers. Facilitates research
proposals supporting the use of Oncology products and manages
the progress of Investigator-Sponsored studies and/or Company
Sponsored studies. Supports sales/marketing group on clinical
issues. Participates in advisory board activities, preparation
of speakers and medical education programs.
Requires MD, PharmD or PhD and 3-5 years of related experience
as a MSL or in clinical research involving Oncology
therapeutics. Related experience in a major academic/medical
center will also be acceptable. Experience with phase III/IV
trials is desired. Must have excellent communications and
presentation skills and be willing to travel up to 60% of the
time. Compensation: to 135K plus bonus, company car and full
expenses.
Medical Science
Liaison(Bioscience) for a worldwide healthcare company.
Field based - openings in the western, southern, eastern and
northeastern regions. Will coordinate and direct
implementation of corporate and clinical approaches to
relationships with KOLs and Clinical Investigators. Participates
in medical education training sessions. Helps in developing
Investigator Initiated and Company Sponsored Clinical Trials.
Provides clinical support to marketing therapy teams. Requires
PharmD, PhD pr MD and 5 + years of related experience in
clinical research. Must have experience in either immunology,
pulmonology or neurology. Must be experience in KOL development,
clinical presentations and medical education. Compensation: to
140K + bonus + stock and travel expenses.
Director Regulatory Affairs for a worldwide biotechnology company and a division of major pharma company engaged in the research, development and commercialization of Oncology therapeutics; located in Northern New Jersey. Responsible for planning, preparing and managing IND, BLA submissions and supplements, CTA filings to health agencies worldwide. Directs coordination/liaison between health agencies concerning strategic decisions and health authority interactions. Provides guidance to multi-functional development teams. Supervises regulatory affairs staff. Requires BS/MS in life science and 5 years of related experience in regulatory affairs. Must understand drug development/regulatory process related to biologic oncology product development. Must understand GCP compliance and application of FDA and ICH guidelines. Compensation: to 165K base + bonus and stock options.
Director, Biostatistics - Oncology for an international company and a leader in the development and commercialization of Oncology therapeutics; located in Northern New Jersey. Responsible for leading and managing biostatistics function involving the design, development and analysis of phase I, II, III trials to support worldwide drug development. Collaborates with clinical investigators to provide statistical expertise concerned with protocol design, statistical analyses and databases. prepares reports for submissions and interacts with regulatory authorities as required. As required, supervises biostatisticians on projects. Requires PhD in biostatistics/statistics and 5-10 years related industry experience and a knowledge of drug development and the IND/NDA?BLA submission process. Must a have a proficiency with SAS, S-PLUS and R programming. Knowledge of exp. design, power calculations, survival analysis and categorical data anlysis. Experience with Oncology clinical development is preferred. Compensation: to 170K + bonus and long term incentive comp.
Director Clinical Pharmacology - Oncology for a worldwide pharmaceutical company in Northern New Jersey.
Will be responsible for planning, design and implementation of early clinical development (phase 1-2a to preliminary proof-of-concept) of Oncology therapeutics.
Will serve as the medical expert for clinical studies and be part of the Translational Medicine team in the development of mechanistic and predictive biomarkers.
Requires MD degree with clinical pharmacology training. Board certified/eligibility in Oncology is preferred. Experience of 7-10 years in the pharma industry or in academia. Knowledge of the drug development cycle is required. Knowledge of FDA, GCP, ICH, EMEA requirements. Compensation: to $220K plus bonus.
Director Global Regulatory Strategy our client is a worldwide biopharm company and a leader in the areas of: diagnostic imaging, oncology, hematology, women's health and specialized therapeutics. Location: Northern New Jersey.
Responsible for planning and managing regulatory projects involving submissions for US and foreign regulatory bodies supporting product development programs. Works with regulatory groups, clinical research, product development teams and commercial groups and interacts with regulatory authorities, ie. FDA, EU agencies including EMEA.
Requires advanced degree (MS, PhD, PharmD or MD) and 10 or more years in the pharma industry and a t least 5 years experience in regulatory affairs. Knowledge of clinical trial methodology, clinical auditing and drug safety analysis. Must have lmpwledge of FDA/EMEA requirements including ICH guidelines. Experience with investigational to marketing submissions and registrations.
Associate Director Market Research, Oncology for a worldwide pharmaceutical company and a leader in the development and commercialization of oncology therapeutics. Location: New Jersey. Responsible for international primary research studies including definition of best methodology and agency selection. Provides market feedback to support global strategic marketing. Coordinates in the design and analysis of primary research projects to include: development of the agency brief; agency selection; selection of methodology; participation of field study; evaluation of results; and results of potential marketing programs. Develops computer-based market forecasting models. Supports secondary marketing groups in developing sales metrics and brand performance analysis.
Requires MBA or other advanced degree in life sciences or public health and 7 to 10 years of pharma experience including several years in marketing research involving pipeline and marketed products in Oncology.
Manager Product Formulations, Skin Care for a worldwide consumer products and leader in skin care and hair care products. Location: Southern Calif.
Will lead a team of scientists in the development of novel skin care products and sun care product formulations to meet market needs . Evaluates and directs the development of new ingredients/technologies. Supervises and provides direction to scientists and technicians. Supports marketing in creating and assessing concepts and opportunities based on technical learing and ingedient function.
MS or PhD in chemistry or related field and 5-7 years of consumer cosmetic industry experience involving formulations of skin care products. Knowledgeable of scientific principles of formulations, ingredient chemistry and industry trends is preferred. Strong leadership and presnetations skills required.