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Clinical Study Manager - (Job Code CTM2016)

Ra Pharmaceuticals is a development stage Biotechnology Company with a platform that enables the discovery of novel therapeutics. Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

The Clinical Study Manager will manage all clinical study activities under his/her responsibility. The individual will manage the strategic and operational elements of study conduct in conjunction with relevant functional lines.

Responsibilities: The primary responsibility will be the successful execution of clinical studies from study planning to closeout. Deliver projects on time, within budget and in compliance to all applicable regulations.

Manage study conduct, ensure operating procedures and company policies are followed and trials meet all applicable regulations and guidelines required. This individual will be responsible for the oversight of the CRO and other vendors, oversight of contracts, timelines and budgets, for studies done in and outside US.

Accountability for the preparation and finalization of key clinical documents, which include the clinical protocol, informed consent, case report form and other essential study documents.

Ensure deliverables are carried out according to the study plan. Ensure enrollment commitments meet the projected enrollment across the regions at the clinical study level, monitor patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.

Exhibit proficiency and act as a Subject Operations Expert in clinical trials involving complex design issues. Will provide solutions and guidance as needed.

Will interface and collaborate with investigators, IRBs/ECs, contractors/vendors and company personnel as required.

Qualifications:

  • A minimum of a Bachelor’s Degree (advanced degree preferred) with at least 5 years of clinical operations or related experience required.
  • Requires clinical operations and GCP/ICH knowledge.
  • Requires strong communication (both oral and written), organizational and interpersonal skills.
  • Ability to foster team productivity and cohesiveness is preferred.
  • Requires experience managing a CRO and vendors.
  • Requires experience in global studies with flexibility and able to manage global or regional teams in a virtual environment.
  • Computer skills and experience with some project management software and tools.
  • Ability to travel (domestic and international).

To apply, please send your resume and cover letter to hr at rapharma dot com.

Associate Scientist/Scientist/Manager Analytical Development - (Job Code ASAD2016)

Description: We are currently looking for a resourceful and motivated individual to join our team as an Associate Scientist, Scientist or Manager. This candidate will have a supportive role in Analytical Development by coordinating and potentially supervising outsourced analytical testing, developing analytical methods and generating reports for regulatory filings. Based upon experience, the candidate may oversee outsourced analytical method development, technical transfers, GMP material release and stability studies. This person will also be responsible for supporting non-GMP in-house stability studies and materials release and will be expected to contribute to method development by developing and improving assays, reviewing data as well as investigating and troubleshooting assays and equipment issues and recommending improvements.

Qualifications: The ideal candidate will have a PhD or a BS/MS in Analytical Sciences or a closely related field and 2-7+ years of industry experience in analytical development or quality control. Experience with analytical development for peptides as well as experience in technical transfers and managing stability studies. Experience with preparing analytical sections of regulatory documents (IND/IMPD) is highly desirable. The successful candidate must be able to thrive and develop in a dynamic biotechnology start-up environment, to complete tasks with a sense of urgency, and have a passion for scientific excellence.

  • BS/MS/PhD in Analytical Sciences or a related field
  • 2 to 7 years of industry experience
  • Experience with Peptide, small molecule and/or protein analytical and characterization techniques
  • Strong understanding of HPLC and UPLC methods (reverse phase, size exclusion, ion exchange)
  • General familiarity with USP and EP compendial methods
  • Driven to solve problems and able to work independently
  • Possess excellent communication skills

To apply, please send your resume and cover letter to hr at rapharma dot com.

Peptide Chemist - (Job Code CHPC-2016)

Description: We are currently seeking a peptide chemist to join our team.  Primary responsibilities will include the design, synthesis, purification and characterization of peptides using state-of-the-art methods.  Additional responsibilities will include the analysis of biological and physicochemical data and the elucidation of structure-property relationships that will guide optimization of drug candidates.

Qualifications: The ideal candidate will have a Ph.D. in chemistry, biochemistry, or a related discipline and 2-5 years of postdoctoral experience.  Demonstrated experience in solution- and solid-phase peptide synthesis including the use of automated peptide synthesizers is required. Experience in general organic synthesis, peptidomimetic chemistry, structure-based design, and medicinal chemistry is highly desirable. Candidates should also demonstrate excellent written and oral communication skills, creativity and initiative, and must have the ability to work effectively as part of a multi-disciplinary team.

To apply, please send your resume and cover letter to hr at rapharma dot com.

Scientist Target Biology - (Job Code STB2015)

Ra Pharmaceuticals is a development stage Biotechnology Company with a platform that enables the discovery of novel therapeutics. Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

Description We are currently seeking a Scientist with expertise in the complement system to join our Target Biology group. Primary responsibilities will include the design, development, and execution of biochemical and cell-based assays for the characterization of drug candidates. Additional responsibilities will include developing expertise in biology of targets and disease areas of interest and using this knowledge to advance projects as a member of a project team.

Qualifications: Candidates must have a Ph.D. in cell biology, molecular biology, biochemistry, or a related discipline with demonstrated scientific expertise in the biology of the complement system. The successful candidate will be a flexible and careful scientist with leadership potential who is eager to learn and excited by the challenges and rewards of working in a highly demanding start-up environment.

To apply, please send your resume and cover letter to hr at rapharma dot com.

Scientist, DMPK - (Job Code PCD2015)

Description We are looking for a highly motivated scientist to work across multiple programs to characterize the pharmaceutical profiles of compounds from discovery through non-clinical development.

This individual is responsible for conducting and coordinating internal and external DMPK and ADME efforts to identify and characterize high quality compounds for preclinical studies and ultimately drugs for development. This includes design and reporting of PK, drug-drug interaction and in vitro stability assays in support of drug discovery efforts as well as regulatory filings. This scientist will work closely with other scientists at Ra Pharma to shape the current and future portfolio of effective drugs to treat diseases in a variety of indications.

Qualifications:

The ideal candidate will have a PhD or equivalent in Pharmaceutical Sciences, Pharmacology, or related field with a specific focus on pharmacokinetics and a minimum of 3 years of experience in the biotechnology/pharmaceutical industry, or an MS with a minimum of 5 years similar experience. Comprehensive understanding of PK and ADME principles, enzyme kinetics and DDI risk assessment are required, as are strong technical in vitro assay knowledge. Knowledge of WinNonlin and preferably NONMEM are required. Strong trouble-shooting and technical writing skills are a must. Experience with in vitro assays for regulatory filings and understanding of regulatory requirements are desirable.

To apply, please send your resume and cover letter to hr at rapharma dot com.

Research Associate, Chemistry - (Job Code RACMS2015)

Description We are currently seeking a research chemist to join our chemistry group and contribute to the synthesis, purification and characterization of small molecules using state-of-the-art methods.

Qualifications:

The ideal candidate will have a M. Sc. in Chemistry, with at least 4 years of synthetic organic chemistry based lab experience. The ability to work independently with a focus on synthesis, characterization and purification of small molecules is required. Candidates must be capable of designing, planning and troubleshooting multi-step, organic synthesis routes, be proficient in identifying structure activity relationships (SAR) to improve lead profiles based on: potency, selectivity, and pharmacokinetics and demonstrate excellent communication skills, flexibility and initiative, and must have the ability to work effectively as part of a multidisciplinary team of chemists and biologists.

To apply, please send your resume and cover letter to hr at rapharma dot com.

Ra Pharma™ is building a dynamic team of scientists to solve the most difficult problems in drug discovery today. We seek highly motivated individuals who enjoy working in a collaborative atmosphere and a goal-oriented environment.

Ra Pharma™ is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits and the opportunity for personal and professional growth in an outstanding and intellectually challenging work environment.