Clinical Scientist 1 or 2

We are seeking a Clinical Scientist 1 or 2 to join our team. The Clinical Scientist 1 or 2 will be a member of a highly collaborative Clinical Development team, with involvement in a diverse range of activities.

This position reports to the Vice President, Clinical Development and will be in Boston, MA, USA. This role is a hybrid position, requiring a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

• Provide scientific input on disease indications, trial designs and scientific rationale for relevant compounds within specific therapeutic areas
• Perform literature searches, coordinate scientific discussions relevant for designing study protocols and interacting efficiently with internal/external collaborators to ensure the trial design meets current regulatory and scientific requirements
• Participate in the development, implementation, conduct and reporting of clinical trials, keeping up-to-date with preclinical and clinical data relevant to the investigational product(s)
• Provide ongoing critical evaluation of development strategies to maintain state-of-the-art clinical development plans that are competitive and consistent with the latest regulatory requirements; proactively identify challenges and develop contingency plans to mitigate
• Participate in monitoring, summarizing and interpreting data from an overall scientific standpoint, assessing the scientific implications and contributing to recommendations that may impact clinical development plans
• Generate and review clinical and regulatory documents, ensuring  scientific and medical accuracy of submissions to the Health Authorities; participate in discussions with the Health Authorities where needed
• Using Company, product and patient knowledge, work with Clinical Operations and CRO to support Investigator identification and site feasibility and selection
• Participate in the planning and study start-up processes for clinical trials by providing, for example, appropriate scientific training and information to the CRO, Investigators and site personnel
• Critically read and evaluate relevant medical literature and keep up-to-date with medical and other scientific developments relevant to the investigational product(s) and disease indication(s)
• Maintain appropriate collaborations and relationships with external scientific experts, thought leaders and the general medical community in accordance with Clinical Development and Medical Affairs plans
• May plan projects and clinical studies with external collaborators 
• Assist in the development of standard operating procedures (SOPs) and guidelines linked with departmental activities
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Other duties as assigned

QUALIFICATIONS:

• MD, PhD, or MSc with experience in pharmaceutical development, preferably in designing and conducting international clinical trials in accordance with applicable regulations
• A minimum of 2 years of Industry Clinical Pharmacology/Clinical Development experience. Job level will be commensurate with years of experience and degree
• At least 1 year of clinical trial design/analysis experience required
• Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company
• Excellent oral and written communication skills with strong attention to detail
• Be science and data driven while at the same time, creative and flexible in strategic thinking and problem solving
• Proven ability to multi-task, prioritize and execute to project timelines

The base salary range for this role is $85,000 to $127,600 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.