Associate Director/Director, Clinical Scientist

Position: Associate Director/Director, Clinical Scientist

Location: Massachusetts, USA

We are seeking a Clinical Scientist, Associate Director/Director, to play a pivotal role in supporting key oncology programs. My client develops precision oncology drugs that attacks vulnerabilities found in tumor cells. This position will report to the Head of Clinical Sciences. The Clinical Scientist will be responsible for providing scientific support for all clinical development activities. If desired the Clinical Scientist may also share or gain experience in our diagnostics development. This role offers a unique opportunity to progress your career by working on novel therapies in the DNA repair field, novel clinical trial designs and innovative approaches to global oncology drug development.

RESPONSIBILITIES

• Contribute to the development of clinical strategies and trial execution
• Perform ongoing review and analysis of study safety and efficacy data
• Provide support as needed for scientific issues that may arise during study execution
• Collaborate with the Clinical Operations group to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), etc.
• Collaborate with the Regulatory group Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents
• Develop relationships with appropriate consultants
• Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
• Understand and support creation and support of competitor landscape, medical need, regulatory strategy
• Perform literature searches and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
• Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied
• Write abstracts and present data at scientific meetings, both internally and externally.
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

QUALIFICATIONS

• B.Sc. or equivalent (at minimum) in life science, nursing, pharmacy, medical laboratory technology or other health/medical related area. Other degrees/certifications considered if commensurate with related clinical research experience (e.g. diploma/associate degree RN, certified medical technologist)
• Postgraduate qualifications highly desirable
• Minimum of 3 years of experience in clinical research and drug development, preferably at pharmaceutical industry.
• Prior Oncology Drug Development experience is required.
• Demonstrated ability to work in matrix teams and in a fast-paced environment.
• Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
• Strong Analytical ability.
• Excellent interpersonal and decision-making skills.
• Ability to work independently and enthusiasm to deliver the program objectives in a timely manner. Negotiation and influential skills are advantageous.
• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.

Apply directly or message me at cgrant@barringtonjames.com