Sr. Clinical Scientist
The Sr. Clinical Scientist supports the assigned clinical study team(s) on one or more clinical studies with various deliverables necessary for effective and efficient clinical development plan execution for the assigned molecule(s)/indication(s). This is a mid-level position in this job family, and the Sr. Clinical Scientist has primary responsibilities for supporting the Clinical Development Lead on study teams, with little to no guidance. Will interact with other cross functional team members to ensure effective representation of the needs of each function within the study protocol and related study plans and may also have external interactions with vendors, investigators, key opinion leaders (KOLs), and cooperative groups supporting the clinical development plan. Success in this role requires a strong understanding of clinical study execution, technical proficiency, scientific creativity, independent thought, effective communication and collaboration skills, and the ability to exercise good judgment within defined procedures and practices to determine appropriate action. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities:
- Demonstrated success in technical proficiency, scientific and/or medical creativity, collaboration with others and independent thought. Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Support Clinical Development Lead of one or more clinical studies in the development of scientific and medical strategy and content for study protocols
- Manage, in collaboration with medical writing, the writing of clinical study protocols and protocol amendments
- Review template informed consent form templates to ensure alignment with protocol and Investigator Brochure(s)
- Participate in cross-functional study team for one or more assigned studies and collaborate with internal and external stakeholders to facilitate understanding and achievement of scientific/medical objectives
- Take primary responsibility for Clinical Development representation in development and review of study charters, manuals, work instructions, case report form specifications, statement of work specifications, etc. to ensure accuracy and alignment with the protocol
- Manage and track ongoing study data and participate in regular in-depth data reviews (data cleaning); prepare and present summaries for internal or external study updates; identify potential issues and present proposals to improve quality, accuracy, efficiency, etc. of study conduct and data collection; present proposals for updated or new research, etc.
- Advise in cross-functional development of strategies for clinical data collection and monitoring and signal detection
- Participate in the planning and execution of investigator meetings, study initiation visits, and study-related committee meetings (e.g., steering committee and independent data monitoring committee)
- Develop study training materials and deliver training to internal and external colleagues and site study teams (e.g., clinical research administrator training, pre-study and site initiation visits, investigator meetings)
- Draft and manage responses to site queries regarding protocol or related data clarifications
- Support in drafting responses for health authority or ethics committee questions and requests for information
- Contribute to the writing and review of data presentations and publications (abstracts, posters, slide presentations, other communications) and may help to coordinate reviews and adjudication with internal and external stakeholders
- Participate in planning and review of statistical analysis plan (SAP)
- Participate in writing and review of clinical study report (CSR) and preparation for potential NDA/BLA filings
- Participate in clinical subgroups in analysis planning and writing for CSR or NDA/BLA filings
- Participate in cross-functional working groups to provide clinical perspectives in the development of program- or company-wide processes
- Participate in planning and writing of Investigator Brochure (IB), IB updates, and Drug Safety Update Report (DSUR)
- Stay abreast of current literature, attend scientific and clinical research conferences, and establish relationships with therapeutic area experts to maintain scientific and clinical knowledge in the assigned disease and therapeutic area(s) and to inform program clinical research objectives
- May act as a standing or ad hoc member of cross-functional sub-teams or working groups
- Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other relevant guidelines
- Other duties as requested
Minimum Qualification Requirements:
PhD required; equivalent experience or other advanced degree (MD, PharmD, MSN, MPH, etc.) may be accepted. Life sciences degree is preferred. Exceptional candidates without advanced degree with demonstrated capabilities and/or significant experience may also be considered. Minimum 5 years of experience in clinical science (or equivalent role) required and 4 years of industry experience preferred. Well-rounded experience in clinical trial design and conduct, including knowledge of GCP and ICH guidelines, good understanding of the multidisciplinary functions within drug development, and experience working collaboratively and effectively in cross-functional clinical study teams. Experience writing, editing and reviewing protocols, informed consent templates, study manuals, vendor charters, conference presentations, journal publications. Experience interacting with KOLs, investigators, coordinators, and other site staff to share knowledge and feedback related to study protocol development and execution. Relevant therapeutic area experience preferred. Demonstrated abilities in critical thinking and research methods; strong independent research and problem-solving skills. Strong organization and time management skills. Strong verbal and written communication skills; experience in delivering written reports and oral presentations within industry setting preferred. Demonstrated abilities to work effectively in a cross-functional team, to influence others, and to effectively manage conflict. Demonstrated exercise of good judgment, effective use of resources, and understanding of when to seek advice or escalate decisions. Ability to be detail-oriented and provide close reviews of extensive documentation to ensure accuracy, completeness, and consistency of study- and program-supporting materials. Effective interpersonal skills amenable to collaboration and building and maintaining relationships internally and externally within relevant fields. Proficient computer skills in Microsoft Office Suite (Word, PowerPoint and Excel) required.