Open Positions

Senior Director or Director, Regulatory Affairs (Candidates Only; No Recruiters)

Ra Pharmaceuticals, Inc. (Nasdaq:RARX) is a clinical stage biotechnology company focused on transforming complement therapeutics by delivering innovative and accessible therapies to patients with rare neurologic, hematologic, and renal diseases.  Ra Pharma combines its expertise in complement with leadership in macrocycle peptide technology to discover and develop therapeutics that transform the lives of patients.

POSITION DESCRIPTION:

Ra Pharma is seeking an experienced and energetic person to be the global and/or US regulatory lead for Ra’s RA101495 program. The position will report to the SVP Head of Regulatory Affairs, Quality, and Government Affairs.  The Director, working with the project team and regional regulatory leads in the US, EU, and other countries, will develop global regulatory strategies, provide regulatory guidance, critically review documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy by the regions defined by the project team’s goals for each of the indications. The position will represent Regulatory Affairs on cross-functional project teams, will provide strategic input to the project team, and will lead the regulatory subteam.   The successful candidate will also be expected to take a hands on role in preparing regulatory submissions including INDs, NDAs and EU MAAs.

JOB RESPONSIBILITIES:

Lead all regulatory activities for assigned projects in line with ICH requirements, regional requirements, and company policies and procedures. Contribute to the development of global clinical and regulatory plans and strategies, identify and propose risk mitigation strategies, and influence project teams and sub teams. Prepare and/or manage submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.  Develop and implement regulatory strategies and of manage complex negotiations with regulatory authorities. Plan, author, and critically review complex technical documents, and influence colleagues across functions. Lead teams in preparation of submissions.  Maintain knowledge of highly complex regulatory requirements, contribute to preparation of new regulatory guidance wherever possible, comment on draft regulatory guidance, and communicate changes in regulatory information to project teams and senior management, and help write scientific justifications in response to regulatory agency inquiries.

REQUIREMENTS:

The ideal candidate should have a minimum of 8 – 10 years overall regulatory experience in the pharmaceutical industry, with a minimum of 5 years of direct experience as a global lead, and at least one successful major application (NDA/BLA/MAA/JNDA, etc.).  Extensive knowledge and understanding of medical and scientific subject matter and past experience with direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) is required.  Experience working directly with Regulatory Agencies in 3 ICH regions. Experience in rare diseases is highly desirable. The candidate should have an advanced scientific degree. The candidate must have excellent knowledge of applicable U.S. and international regulations and guidelines. Excellent oral and written communication skills are a must as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

To apply (candidates only; no recruiters): Email resume to hr@rapharma.com

We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V

Director/Senior Director of Nonclinical Development

Ra Pharmaceuticals (Nasdaq:RARX), a clinical-stage biopharmaceutical company based in Cambridge MA, is focused on the discovery, development and commercialization of novel therapeutics based on its proprietary peptide chemistry platform.  Ra is developing therapeutics to treat serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.  Ra Pharmaceuticals is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company. 

POSITION DESCRIPTION:

We are currently seeking a Director/Senior Director of Nonclinical Development to lead the development and execution of pharmacology, pharmacokinetic, and toxicology studies in support of the Ra Pharma pipeline. The ideal candidate will be familiar with the international regulatory requirements for toxicology and pharmacology and have experience with the development strategies for small molecule and/or peptide therapeutics.  Primary responsibilities will include development and implementation of program-specific pharmacology and toxicology strategies in support of a rapidly growing portfolio. Candidates should be self-motivated with experience working and leading in a highly collaborative cross-functional environment.

JOB RESPONSIBILITIES:

  • Support the development of novel therapeutic agents from early phase to late phase, including regulatory submissions and health authority interactions. Characterize the pharmacology and toxicology profile of candidate molecules and provide input into investigative studies and clinical starting dose strategies.
  • Serve as a subject area expert in nonclinical development across pharmacology, toxicology, and pharmacokinetics.
  • Interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to pharmacology, toxicology and nonclinical drug development in general.
  • Contribute to the development of nonclinical models to probe the efficacy and PK/PD relationship of novel therapies.
  • Address and resolve scientific issues arising in drug discovery/development programs.

REQUIREMENTS:

  • Ph.D. or equivalent in pharmacology, toxicology or a related discipline and a minimum of 4-6 years of industry experience.
  • Experience designing, monitoring, and interpreting GLP toxicology data for small molecule and/or peptide programs.
  • Experience interacting with global health authorities, and an in-depth understanding of the relevant pharm/tox regulatory guidances.
  • The successful applicant should have experience authoring relevant sections of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
  • Experience working on the development of rare disease therapies is preferred.
  • Strong scientific background and experience designing and interpreting early nonclinical efficacy and PK/PD studies.
  • Experience leading matrixed drug development teams or sub-teams.
  • Able to solve technical problems with enthusiasm in a team environment
  • Good written and oral communication skills
  • Ability to thrive and develop in a biotechnology culture

To apply: Email resume to hr@rapharma.com

We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V

Head of Medical Affairs, North America

Ra Pharmaceuticals, Inc. (Nasdaq:RARX) is a clinical stage biotechnology company focused on transforming complement therapeutics by delivering innovative and accessible therapies to patients with rare neurologic, hematologic, and renal diseases.  Ra Pharma combines its expertise in complement with leadership in macrocycle peptide technology to discover and develop therapeutics that transform the lives of patients.

POSITION DESCRIPTION:

Reporting to the Chief Medical Officer, the Head of Medical Affairs for North America is the subject matter expert responsible for building a US Medical Affairs organization and developing strategic and tactical plans to support the development and preparation for the launch of zilucoplan, a next generation subcutaneously self-administered C5 inhibitor across multiple complement-mediated disorders including generalized myasthenia gravis and other neuromuscular and neurological diseases.

RESPONSIBILITIES:

An integral role of the Head of Medical Affairs for North America will maintain the content and tenor of Ra’s scientific communications with the HCP and Research Communities. Supporting the development of high quality educational content such as slide decks, medical presentations at conference, advisory boards, and cross functional review of promotional materials. Furthermore, the Head of Medical Affairs will advise on the developing Phase IV commitments and co-lead the development of post-marketing data generation. Specific responsibilities for this role will include but are not limited to:

  • Recruit a top notch medical science liaison (MSL) team covering the United States and Canada
  • Represent Ra Pharma at local/national/international scientific congresses and professional society meetings
  • Representing Ra Pharma at local/national/international patient advocacy activities
  • Provide support/direction, where necessary, for study design and execution for global medical affairs studies
  • Represent Ra Pharma as scientific contact at key national/local congresses or professional society meetings
  • Provide medical input into developing global strategic launch plan, training materials, and medical information
  • Provide scientific and medical support for publications and presentations as needed
  • Support internal and external requests for KOL engagement, strategic alliances, and collaborators
  • Educate KOLs about Ra Pharma scientific platform, mechanistic approach, and commitment to MG and other complement-mediated disorders
  • Serve as a clinical and content expert for internal stakeholders
  • Participate in the review and approval of investigator initiated studies
  • Ensure consistent and accurate medical communications
  • Provide medical support for key commercial activities

QUALIFICATIONS:

  • Physician leader (MD or international equivalent) required
  • Experience in Neurology and/or Rheumatology preferred
  • The ability to travel nationally/internationally as required (30%)
  • Ability to understand and communicate complex analysis
  • Team orientated and ability to work collaboratively towards common objectives

Please submit cover letter and resume to hr@rapharma.com

We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V