CURRENT OPENINGS

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.

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.

Clinical Research Medical Director, Pulmonology for a worldwide biotechnology company in Southern CA.
Develops and executes medical strategies and provides scientific and medical input in support of Asthma molecules in development currently in Phase II. Develops and manages key external and regional relationships according to the KOL plan. Authors clinical strudy reports, publications and regulatory submissions. Designs, prepares and initiate study protocols and related documents in compliance with FDA requirements, GCP and good medical practices. Requires MD with Board certification/Eligibility in Pulmonology or Allergy/Immunology.
Three to Five years of clinical research experience combined with clinical teaching and patient care. Knowledge of FDA, GCP, EMEA regulations and guidelines. Knowledge of basic concepts of clinical research and clinical trial design. Must be effective at writing clinical documents and in presenting clinical information.
Compensation: to 230K + bonus + stock options.

Director Regulatory Affairs CMC for a global pharmaceutical company developing and commercializing innovative products worldwide. The company is located in Southern California. Will provide leadership within Global RA involving CMC submissions involving the development and implementation of CMC strategies throughout the lifecycle of biologics or pharmaceuticals. Maintains relationships with regulatory authorities to facilitate interactions and relationship management involving submissions. Ensures submissions meet appropriate standards and content requirements. Supervises, leads and mentors regulatory staff; and develops and manages dept. budget. Requires BS in a scientific discipline with 10 years of experience in regulatory affairs to include several years in CMC submissions; and several years managing a regulatory staff. Expert knowledge of regulations, current industry practices and the ability to interpret and apply regulations. Strong negotiation skills and verbal/written communication skills, presentation and facilitation skills. Strong leadership and management skills of regulatory staff. Compensation: to 175K plus bonus and stock options.

Sr. Manager/Assoc. Director, GCP QA for a pharmaceutical company in San Francisco, CA. Develops, implements and oversees the management of the Clinical QA activities supporting coporate and quality goals. Works with Clinical Operations and project teams to ensure clinical studies are in compliance with FDA regulations and ICH guidelines for GCP and SOPs. Responsible for assisting with ongoing development of the GCP QA audit program including resource planning, scheduling and executing audits and activities to improve quality systems. Requires BS/ BA in science, nursing or related discipline (with advanced degree preferred). Ten years of pharma industry experience in clinical research with a 5 years mangement experience in Clinical QA or GCP compliance. Thorough understanding of FDA regulations and ICH GCPs in the drug development process. An understanding of software validation and electronic data capture systems. Strong project management skills along with strong verbal/written skills and the ability to work with teams and independently. Compensation: to 140K plus bonus and stock options.

Director Global Medical Affairs, Hemophilia for a worldwide healthcare company and a leader in the development and marketing of hemophilia therapeutics; located in New Jersey. Responsible for planning and implementing clinical studies for the Hematology Global Brand Team and to ensure the commercialization of products. Develops medical strategies for Phase IV studies and coordinates the design, conduct, analysis, reporting and publication of medical affairs clinical studies. Provides medical expertise on commercial issues to the Global Brand Teams. Plans and conducts scientific advisory boards with key opinion leaders (KOL) and external customers. provides medical review of promotional material for global use to include brochures, press releases and field communications. Lead medical affairs activities on the scientific publication process, KOL development programs and global medical congress activities.
Requires MD/PhD with post graduate medical training in hematology/hemophilia with a minimum of 4 years experience in clinical development and/or medical affairs in a global healthcare/pharmaceutical company. Must have therapeutic/disease state knowledge in hemophilia drugs. Must understand the drug development process from phase I to phase IV, and understand global regulations and guidelines. Experience in managing teams in different cultures and geographies. Compensation: to $205K plus bonus; relocation assistance will be provided.

Director Global Quality Management (cGMP) for a worldwide pharmaecutical company and a leader in the development and manufacturing of recombinant therapeutic proteins for the production of biologic medicines for the treatment of various forms of bleeding disorders; located in the San Francisco, CA area. This position will play a key role in providing strategic direction and leadership for all quality management worldwide, focusing on risk management, compliance, supplier assessment, auditing and training for product supply quality. Will establish quality practices and systems including oversight of the CAPA system and customer complaints and for generating quality policy and standards addressing regulatory requirements and company policies and directives. Will directly supervise a staff of 6 to 8 direct reports. The Director will operate in the highly and tightly regulated industry of Biological Products involving highly complex regulatory compliance issues with cGMP regulations and standards established by federal law and involving domestic and international commerce.
Requires advanced degree (Masters or PhD) and 10 years experience in pharmaceuticals (biologics) and 7 years in management positions to include QA, Systems, Quality Management or Regulatory management experience. Broad cGMP experience experience and knowledge, QA/QC and regulatory compliance (US and international agencies). Must have strong leadership and interpersonal skills; communication skills and good presentation skills. Ability to interact with senior management and to work in teams and peer relationships. Compensation: to $200K plus bonus; and relocation assistance.