About Us
About the Role
As the Director, Clinical Development Scientist (CDS), you will play a key role in designing and execution of the important clinical studies. You will be part of the team leading the first in patients, clinical trial/s involving a novel complement inhibitor. Success of these trial/s will support further clinical development of the novel asset/s with significant positive impact on multiple stakeholders, including patients suffering from rare, life-threatening neurological conditions.
You will report to our Vice President, Clinical Development and will provide input into a clinical study protocol and support a clinical study team. You will support assigned clinical development physician leader and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution. You must have strong scientific background in in the areas of neurology and/or immunology. Prior experience in drafting of study documents such as protocols and regulatory filings is essential. You must have excellent oral, and written communication skills, with the ability to work independently in a fast paced, entrepreneurial setting involving internal and external stakeholders.
This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by continuous innovation with very high scientific integrity. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
- Liaising with other functions to enable quality clinical study execution; Provide input to the study team for country and site feasibility assessments.
- Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
- Participating in virtual or on-site initiation (and/or feasibility) meetings.
- Monitoring, cleaning, analyzing and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
- Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities.
- Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents.
- Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy.
- Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
- Supporting development of presentations and publications arising from studies and other relevant initiatives.
- Providing support for business development activities, such as due diligence and research collaborations.
- Where appropriate, serve as the SME for identification, training, translation, inclusion, implementation and reporting related to the study endpoints.
Experience
- Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)
- Understanding of general (specifically rare disease, immunology or neurology) therapeutic principles
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Familiar with scientific literature searches and weighing of quality peer reviewed data
- Ability to clearly communicate to internal and external stakeholders orally and in writing
- Neurology and/or rare disease therapeutic area experience
- Basics of strategic vs. tactical thinking
- Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
- Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
