Director, Clinical Research (MD) – Hematology
Ra Pharma is a clinical stage biopharmaceutical company that combines expertise in complement biology with proven leadership in peptide chemistry to transform the lives of patients with serious and life-threatening disorders. Ra’s proprietary peptide chemistry discovery engine has identified drug candidates that combine the diversity and specificity of antibodies with the favorable pharmacological properties of small molecules. Our primary clinical focus is on rare diseases of complement dysregulation, including paroxysmal nocturnal hemoglobinuria (PNH), generalized myasthenia gravis (MG), and other complement-mediated disorders.
The clinical research physician will report to the Chief Medical Officer and will play a key role in all stages of clinical development from drug discovery through to registration studies. The successful candidate will have oversight for ongoing and planned clinical trials in paroxysmal nocturnal hemoglobinuria and other complement-mediated disorders.
Essential Duties and Job Functions
- The initial focus of this position is to advance the clinical development of zilucoplan (RA101495 SC), a subcutaneously-administered inhibitor of complement component C5, through Phase 3 and to approval in patients with paroxysmal nocturnal hemoglobinuria.
- Will be part of a team responsible for all scientific aspects of designing and conducting clinical trials.
- Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
- Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
- Coordinates the collection and analysis of clinical data for internal analysis and review.
- Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
- Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
- Develops manuscripts for publication in peer-reviewed journals.
- Will be part of a team responsible for defending the clinical development program before regulatory authorities.
- Serves as a scientific and clinical expert within Ra Clinical Research.
- Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Drug Safety, Regulatory, and Project Management staff.
- Contributes to the clinical evaluation of business development opportunities.
Knowledge, Experience and Skills
- MD or MD PhD required; postgraduate training in internal medicine required; board certification in hematology preferred but not essential
- At least three (3) years of industry or academic clinical trial experience with a proven track record in clinical research studies and trial design and execution
- A strong publication record and formal training in biostatistics is preferred
- Familiarity with Good Clinical Practices (GCP).
- Experience in rare disease drug development.
- Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
- Strong leadership skills with an ability to set vision, lead change, and mentor others.
- Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
- Outstanding scientific written and oral communication skills.
- Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
- Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
- Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings.
To apply: Email resume to email@example.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