Associate Director, Clinical Scientist

The Associate Director, Clinical Scientist will execute and lead clinical development activities for one or more assigned studies, acting as the leader on assigned study teams and departmental initiatives. They will contribute to the development of the clinical strategy, developing awareness of the competitive landscape and wider company strategy. This onsite position can be located at our US locations in either Conshohocken, PA or Gaithersburg,MD.

KEY RESPONSIBILITIES
Develop study concept, including overall study design, schedule of assessments, objectives / endpoints, and eligibility criteria. Integrate feedback from internal and external stakeholders including senior leadership, key investigators, and regulatory agencies.
Contribute to authoring of the study protocol and provide critical feedback and review of supporting documents; help to respond to health authority feedback.
Provide protocol trainings to internal and CRO teams
Contribute to design of study-specific case report form (CRF), ensure CRFs are aligned with study requirements during user acceptance testing, and author study-specific sections of the CRF completion guidelines.
Ensure study manuals, etc. are aligned with the study protocol.
Support successful collaborations with investigators, including conducting and participating in pre-site selection discussions, site initiation visits, and investigator meetings.
Serve as clinical representative on internal and external meetings.
Conduct and oversee real-time clinical data reviews (including oversight of CROs when applicable), including identifying trends in safety and efficacy data, reviewing SAEs and AESIs, and assessing protocol compliance, escalating to Medical Monitor when appropriate.
Perform analysis and help to interpret clinical data, lead authoring of selected sections of clinical study reports.

Other
Provide expert, collegial support and leadership to achieve study and program objectives.
Collaborate with Regulatory and Compliance to foster a compliant, high-quality, and inspection-ready culture, adapt to changes in regulatory requirements, and improve SOPs and work instructions.
Contribute to continuous improvement and process development initiatives.
Help to ensure deliverables and milestones are met within timelines and budget.
May present program strategy and results to internal and external stakeholders; may help to author congress abstracts / presentations and primary manuscript.
May mentor and/or supervise clinical science contractors.

Experience & knowledge
Essential
Understand the principles of GCP, applications to own work.
Understanding and experience in the processes of oncology drug development.
Strong data analysis, data visualization, and communication skills, with ability to write clear, accurate, and concise documents, construct informative figures, and present to diverse audiences.
Experience contributing to core study documents.
Able to safeguard patient safety in clinical studies, including identifying trends in AE and lab data, reviewing SAEs and AESIs, developing risk mitigation strategies, and understanding when to escalate to the Medical Monitor.
Self-motivated; demonstrated success in delivering assigned tasks according to timelines.
Demonstrated history of creative problem-solving and learning agility.
Effective collaboration with as well as ability to impact and influence cross-functional teams and, in selected situations, senior leaders.
Successful in fast-paced environments with ability to effectively manage multiple tasks and competing priorities.

Desirable
Strong publication and presentation record.
Experience supporting interactions with global health authorities.
Background in immunology and experience developing immunotherapeutics.
Experience working with CROs including providing oversight.
Experience incorporating, implementing, and evaluating translational endpoints.
Experience integrating clinical and translational data to support dose selection.

Education & qualifications
Requires at least 1 year of prior experience in the role of clinical scientist.
Requires a PhD, PharmD, RN, or MD and 10+ years related experience or MSc / BSc degree with extensive (14+ years) role-specific equivalent experience.
Periodic travel (~15-20; includes overnight domestic and international travel to study sites, conferences, and meetings).
Attendance of leading industry meetings as required.