Vice President Clinical Operations for a leading biotechnology company specializing in Oncology therapeutics; located in Northern NJ. Responsible for managing operational planning and activities for the implementation and conduct for all clinical trials globally (Phase I-IV) across all areas of compliance with health authorities guidelines and company SOPs; and established timelines and budgets. Responsible for strategic resource management to include resource forecasting and allocation. Requires 5-10 years in a leadership role involving clinical operations/trial management. Managerial experience in planning, executing, reporting and publishing clinical studies in a pharma company or CRO. Advance experience in Oncology clinical development. Bachelor's degree in Life Sciences (Advanced degree PhD or PharmD) preferred. Thorough knowledge in GCPs, clinical trial design, regulatory process and global clinical development process. Must understand health authority regulations, ie. FDA, ICH. Strong leadership and management experience of clinical research staff including study managers, CRAs, monitors and study coordinators. Compensation: to $250K range + bonus + stock.

Associate Director Clinical QA for a leading biotech company in Northern New Jersey. Manages the clinical QA function and oversees CQA staff in the performance GCP audits. Performs GCP training of staff. Prepares company and clinical sites for regulatory authority inspections and participates on inspection team. Requires BA/BS in Life Sciences and 5-7 years of clinical QA experience including planning, managing and performing internal and external audits. Knowledge of GCP regulations, Part II regulations, guidelines and clinicqal QA audit process.
Supervisory experience required. Compensation: to $130K range + bonus + stock.

Director Clinical Project & Portfolio Mgmt. for a leading biopharma company in Northern New Jersey engaged in the development and commercialization of cancer therapeutics worldwide. Will serve as the project leader in preparing product Development Plans in line with R&D objectives; defining target product profile, budget and milestones. provides planning and tracking support for Project teams using state of the art Proj. Mgmt. expertise and software. Assures project support of functional teams - Commercial, Clinical, CMC, Pharmacology are aligned with product Development Plan. Requires advanced degree in life sciences and 5 + years of related pharma experience. Must have in-depth knowledge of the pharma R&D process and demonstrated analytical and information technology skills, and an understanding of project planning software. Compensation: $170K range + bonus + stock options

Leads associate directors and clinical trial managers in implementing clinical development plans, ensuring adherence to company standards and applicable regulations and guidelines. Provides technical and managerial leadership and organizational improvement to clinical operations. Oversees CRO activities. Provides assessment of training needs and performs recruiting, hiring, and performance evaluation of staff. Requires advanced degree - MS, PharmD or MPH and 15 years experience in life sciences, including 10 years in the biopharm industry including several years in a leadership role. Must have skills in clinical development programs and proficiency in clinical studies involving complex design issues, ie. multiple arms, crossover, double blind and multi-center. Experience should include work in preparing the clinical sections for INDs, BLAs or NDAs. Must have strong leadership and management skills. Compensation: to 180K range + bonus+ stock options and full relocation.

Senior Research Scientist - Medicinal Chemistry (several positions are available) for a leading biopharma company engaged in the discovery, development and marketing of anti-infective therapeutics; located in the SF CA area. Responsible for the design and synthesis of novel small molecules for the discovery of drug candidates for the treatment of anti-viral diseases. Requires Ph.D. in Organic Chemistry with an emphasis on synthetic methodology. Must have 6 + years of industry experience involving medicinal chemistry within a biotech or pharma company. Must have a record of accomplishment demonstrating proficiency in synthetic skills and a knowledge of modern synthesis techniques. Must have effective verbal and written skills; presentation skills; and a significant publication record. Compensation: to $120K range + bonus + stock and full relocation assistance.

Medical Science Liaison (Oncology) for a worldwide biotechnology company with HDQ in Calif. The position will be field based in designated areas: NE, SE, MW and West.. Leads clinical research projects and develops and fosters relationships with Key Opinion leaders, clinicians, and medical institutions. Supports both investigator and company sponsored clinical studies. Works with clinical investigators to develop and evaluate clinical protocols. Manages investigator and company sponsored clinical studies for Oncology. Participates in medical education and disseminates scientific information regarding research and disease concepts. Requires advanced degree (MD/PhD/PharmD) and several years of clinical experience in Oncology. Field medical liaison exp. or related clinical research exp. is preferred. Exp. in giving public presentations and educational program development is preferred. Compensation: to $120K range _ bonus+ stock options.

Sr. Director, Medical Affairs (Hepatitis Programs) for a worldwide biopharmaceutical company; located in the SF, CA area.
Responsible for the preparation of medical affairs documentation, scientific summaries and regulatory documentation including summaries and analysis of ongoing investigator-initiated studies and clinical study reports and protocol preparation for company sponsored trials. Coordinates Phase 4 clinical studies of Hepatitis programs studies and supports medical activities for the Hepatitis programs franchise. Prepares abstracts, posters, oral communication for scientific meetings. Plans and delivers medical affairs strategies for maximizing product potential and commercialization of the company's hepatitis products. Collaborates with commercial teams on HBC projects such as Speakers meetings, Regional Consultant Meetings and conference meetings. Collaborates with the MSL group on special projects. Requires MD with strong medical competence in hepatitis B. Must have 5 + years of related clinical experience with anti-virals, preferably with hepatitis products. Experience with protocol design, study conduct and manuscript writing are required Must have a thorough understanding of the clinical drug development process and the commercialization of hepatitis products. Must have strong leadership and management skills and well developed verbal and communication skills. Must have the ability to maintain a high-visibility presence both inside and outside the company. Compensation: to $200K range + bonus + stock options.

Associate Director, Global Regulatory Affairs for a worldwide biopharmaceutical company located in the SF, CA area. Responsible for leading and managing regulatory activities in line with FDA and ICH guidelines. Prepares submissions (including clinical trial applications), NDAs for the US and in overseas countries such as Latin America, Africa, and Asia. Requires MS or PhD. and 10 + years of relevant experience in global regulatory affairs Must have knowledge of regulatory requirements including FDA and ICH guidelines and an understanding of global and regional trends for assigned territories. Must have leadership and management skills in directing regulatory teams. Compensation: to 180K range + bonus + stock options.

Sr. Director HIV Medical Affairs for a worldwide biopharmaceutical company and a leader in the discovery, development and commercialization of antiviral therapeutics; located in the SF, CA area. Manages the development and implementation of medical strategies and clinical plans for the company's HIV franchise. Manages relationships with KOLs and directs clinical trial initiatives (ie. Phase IIIb/IV). Writes protocols including evaluation of study designs. Participates in product review and leads medical affairs to develop clinical strategies and coordinates activities with the commercial group.
Requires MD with ABIM cerification in Infectious Disease or Internal
Medicine and related experience of 8-12 years preferably in medical affairs and several years in a leadership role. Must understand the competitive landscape regarding the diagnosis and treatment of HIV. Must have strong communication and interpersonal skills and the ability to build consensus and drive projects to completion in a team environment. Compensation: to $225K range + bonus + stock.

Associate Medical Director of Medical Affairs (Dermatology) for a leading company in topical formulations development and commercialization; located in Northern Calif. Responsible for medical affairs activities to support comercial brand strategies and medical support for clinical development programs. Provides clinical expertise and approval of clinical protocols, clinical study documents and study reports. Provides medical leadership of brand-related medical information. Develops and executes post approval clinical programs in response to regulatory commitments and brand strategy to support medical marketing messages. Works closely with marketing, legal, regulatory and clinical. Evaluates and manages investigator initiated proposals and development of the process.
Requires MD with board certification/eligibility in Dermatology or equivalent and 2 years clinical or industry experience. Medical marketing experience is a plus. Proven ability to develop relationships with KOLs in Dermatology. Compensation: to $170K range + bonus + stock.

Director Clinical Affairs for a leading company in topical formulations development and commercialization; located in Northern Calif. Responsible for managing the development and review of protocols, informed consents, case report forms, clinical study reports and monitoring tools. Develops and manages clinical study budgets. Maintains internal contact with data management, regulatory, pre-clinical, QA, drug safety and biostatistics. Provides direction to contract CRAs and maintains assurance of regulatory compliance of investigational sites with SOPs, FDA and ICH guidelines.
Requires BS degree in a scientific discipline or health-related area (advanced degree preferred) and 5 or more years of clinical research monitoring experience. Must have experience in Phase I-III clinical development including protocol development and managing budgets. Knowledge of GCP, ICH guidelines and FDA regulations. Must have problem-solving ability in managing clinical sites and skill in dealing with Physicians and study coordinators. Compensation: to $160K range + bonus + stock.

Market Research Manager for a leading biotechnology company engaged in the discovery, development and commercialization of Oncology therapeutics worldwide; located in Northern, NJ.
Provides leadership of market research activities in the development and implementation of product business plans to support pipeline products and business development activities. Designs and analyzes qualitative and quanitative marketing research projects. Works with bread teams to provide analyses of primary/secondary data and guidance in developing strategies and business plans.
Requires bachelor's degree (MS/MBA preferred) and 3-5 years experience in marketing/market research in the healthcare industry. Oncology market research experience is highly preferred. Must have strong understanding of primary and secondary research sources and databases. Compensation: to $125K range + bonus + stock.

Clinical Communications Manager - Bioscience for a worldwide healthcare company engaged in the discovery, development and marketing of biosurgical, plasma, hemophilia and vaccines products; located in Southern Calif.
Provides clinical support within a specific therapeutic area, leading strategic assessment, planning and execution of scientific communications. Will supervise and train staff members within the therapeutic area. Provides medical/clinical expertise on products to internal groups such as marketing, manufacturing, QA, regulatory, R&D, and legal; and external healthcare professional, patients and advocacy groups. Reviews and approves advertising, promotional, scientific and educational materials within the therapeutic area.
Requires PharmD, PhD, or MD and 3 + years related clinical experience in pharma, medical or biotech. Knowledge of bioscience type products would be a plus. Must have strong interpersonal and communication skills; effective presentation and teaching skills; and the ability to influence, initiate and change in complex multi-faceted questions issues. Compensation: 100K range + bonus + stock.