Pharma, medical device jobs, MD's PhD,s, Masters 120-255K base

please explain why you are a good fit for the job you select in your email The medical device jobs, VP and GM are last in the list

RESEARCH SCIENTIST-PROTEIN PURIFICATION, Ph.D., pharmaceutical manufacturing of API, large molecule or protein purification, protein chromatography / tangential flow filtration (TFF) / protein crystallization, background in Protein Biochemistry

Director Parenteral Manufacturing and Technology, up to 165K base, up to 30K bonus,Relocation Assistance Available - Yes, 10+ to 15 years of experience, Management Experience Required - Yes, Minimum Education - Doctoral, Willingness to Travel - Occasionally, Prior experience with both small synthetic organic molecules as well as proteins is strongly preferred.

Medical Director - Insulins, Clinical Research Physician, up to 255 base, up to 50K bonus Medical Doctor or Doctor of Osteopathy. Must be board certified in Endocrinology and Metabolism or have completed the comparable level of post-medical school clinical training relevant to the United States. Experience in clinical research. Experience in or demonstrated evidence for the capacity to lead, manage, and develop groups of professionals. Direct reports: Approximately 4 (1 MD and 3 Clinical Research Scientists).

Endocrinologist (base) +/- $200k. We can look at academic investigators as well as industry but the common thread is the candidate MUST have prior work experience in clinical trials. 4 openings, deep experience in Phase I-IV clinical trials. Education/Certifications MD. Completion of Residency Program in medical specialty. Board certification in sub-specialty, preferred. Professional Qualifications • Understanding of the clinical trial process and regulatory guidelines. • Experience with the execution of clinical trials including early phase studies, regulatory agency interactions and responses is highly preferred (*please forward list of studies in which you have participated, including role and study dimensions). • Current state licensure to practice medicine. • Strong interpersonal, verbal and written communication skills

VP Clinical Development / Senior Medical Director, Salary target 225 maybe up to 250k. bonus target 20%, stock options, depending on experience level. direct development of anti-bacterials, MUST BE AN M.D. WILL only interview MDs who have recent (within the last 3-4 years) interactions of anti-bacterials at the FDA. Must know and have had had discussions with FDA on clinical programs in anti - bacterials. Must know current Cap and SSSI guidance documents for clinical trials. Must have run and managed clinical trials for antibacterials in the US and broad. The company is also utilizing its series of proprietary lead compounds from our novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Addressing the need for novel antibiotics that act against drug-resistant bacteria. Education/Certifications - • MD Professional Qualifications - The successful candidate will have prior experience and a demonstrated track record in a senior level clinical development or regulatory affairs function, such as a Director or Vice President. The candidate’s background will evidence increasing levels of responsibility within the Pharmaceutical, Biotechnology or CRO industry. Moreover, requirements include a demonstrated understanding of, and the ability to interpret, GCP/ICH/FDA standards and guidelines, as well as a clear understanding of internal and external resource management. The selected candidate should possess a strong desire to work in an innovative, emerging company and the accelerated growth environment that it entails.

SR. MEDICAL DIRECTOR CARDIOLOGY, Preferably 10, but at least 5 years of directly relevant cardiovascular, pharmaceutical industry experience, This position is responsible for global clinical development strategy and assessment of clinical feasibility and strategic planning of clinical trial programs or studies. The qualified individual is an expert in the field of Cardiology who will lead and moderate investigator and medical advisory meetings with clinical experts, serving as the clinical point person. • MD degree • Board certifications preferred

Clinical Development Head (VP), Anti-Virals, Resources from Companies of main interest are Roche / Schering / Vertex. Experience leading clinical development teams in drug development. PHASE 3 CLINICAL TRIALS TO Commercialization JOB LOCATED IN THE USA with potential transfer to the UK after 2 years (relo to the UK is not totally required) •Build and lead a group responsible for translating successful pre-clinical results of liposomally-encapsulated glycobiology compounds against HCV into commercial product. Qualifications: Education/Certifications •PhD, PharmD, MD or other advanced scientific educational credentials. Professional Qualifications •Obtained regulatory approval of an anti-viral, preferably HBV or HCV. •Involved in the development of a liposomally-encapsulated product.

Therapeutic Area Head (Senior Director) Neurology MD Neurologist Education/Certifications MD degree. Board certifications preferred. Professional Qualifications •5, preferably 10, years of directly related pharmaceutical industry experience in neurology and stroke.

Business Unit/General Manager - Medical Equipment / Devices 10+ to 15 years of experience, (we are not looking for BD, SM people, we want a GM with experience getting medical device products into large, national retail stores and pharma chains) 5+ years experience in the medical device industry with medical device products sold to RETAIL EXCLUSIVELY (major drugstore chains, big box, department stores). - Oversee the product development process from concept through successful launch. Work closely with supporting departments, including: - Minimum of 10 years experience in the consumer products industry as a general manager with products sold to retail stores, including drug stores, department stores, big box stores, etc. - Experience with FDA-regulated medical device products - Experience with retail buyers, including creating and giving presentations.

The following are all party of government research to be located in Maryland or DC, -3.5 year project with annual renewal, 1099 with no benefits, relo assistance

Reg Affairs/Quality Assurance, Product Development, 2 openings, up to 150K base, 5+ to 7 years of experience Minimum Education - Master's Degree Provide subject matter assessment of regulatory submissions with particular input regarding early product development aspects of contracted activity, to assist in identifying deficiencies or problems regarding clinical issues prior to submission to the FDA; review and assess product development related documentation, presentations and meeting proceedings to provide regulatory issues input during the entire product development process with particular emphasis on clinical study-related activities of BARDA contracted activities; provide clinical study subject matter expert advice and guidance on dealing with regulatory and/or quality assurance issues involving the contracted countermeasure sponsor, the FDA, CDC, NIH, and DoD cooperative projects, including meeting proceedings and possible site visits/audits (inspections); in some instances may interface with relevant FDA Centers regarding clinical 29 studies aspects of regulatory and/or quality assurance issues associated with the product development throughout the investigational, advanced development, approval, and post marketing phases of countermeasure development; conduct site visits, as needed, in accordance with FDA regulations and FAR/HHSAR regulations, pertaining particularly to aspects of product clinical development, including but not limited to clinical study planning design, execution and reporting, and post approval regulatory requirements. A Master's degree or PhD/MD/PharmD and a minimum of 5 years of experience in FDA-regulated drug, medical device and/or biologics industry including significant experience directly involved with early product development aspects such as preclinical research, toxicology and animal modeling.

Vaccines and Biologic Development SME, 6 openings, up to 180K base, 15+ years of experience Minimum Education - Master's Degree A MS (Ph.D. preferred) in microbiology, virology, immunology, biochemistry, or chemical engineering; 15+ years of biologic manufacturing experience, especially vaccines and biologic products; Is knowledgeable in Center for Biologics Evaluation & Research hurdles and current Good Manufacturing Practices; Expert in vaccine/biologics development, familiar with manufacturing processes associated with vaccine/biologics; Experience in identifying and resolving regulatory and manufacturing technical problems; Knowledge of routine analytical methods used to access vaccine/biologics quality; Ability to determine the most appropriate methodology for the validation of the manufacturing process; with a good understanding of Center for Biologics Evaluation & Research regulatory hurdles; Excellent people skills, with a team oriented leadership approach.

Vaccines/Biologic Development (Manufacturing SME), up to 180 base, 2 openings, Minimum Education - Master's Degree A MS (Ph.D. preferred) in microbiology, virology, immunology, biochemistry, or chemical engineering; 15+ years of biologic manufacturing experience, especially vaccines and biologic products; Is knowledgeable in Center for Biologics Evaluation & Research hurdles and current Good Manufacturing Practices; Expert in vaccine/biologics development, familiar with manufacturing processes associated with vaccine/biologics; Experience in identifying and resolving regulatory and manufacturing technical problems; Knowledge of routine analytical methods used to access vaccine/biologics quality; Ability to determine the most appropriate methodology for the validation of the manufacturing process; with a good understanding of Center for Biologics Evaluation & Research regulatory hurdles; Excellent people skills, with a team oriented leadership approach.

Warm Regards, ciao, Namaste
Joe
Joseph Anthony Vaccariello
860 889 4141, until 9 PM EST, 7 days a week
joseph8601@sbcglobal.net
A New Beginning-Genesis 2
http://www.linkedin.com/pub/3/945/77