Clinical Scientist, Breast Cancer

Associate Director/Director, Clinical Scientist, (Breast Cancer)

Reports to Sr. Director, Lead Clinical Scientist

Opportunity

The Associate Director/Director, Clinical Scientist provides scientific expertise necessary to design and deliver clinical studies. This role will provide clinical expertise and leadership in support of new product development and marketed products for the team.

We are seeking an Associate Director/Director, Clinical Scientist to join our Solid Tumor Clinical Development department. This role contributes/leads to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director/Director, Clinical Scientist will participate in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. Reporting to the Senior Director, Clinical Scientist, this role will collaborate closely with Medical Director(s) (Directors clinical development) to provide scientific expertise necessary to design and deliver on clinical studies and/or programs.

Domestic and international travel may be required (approximately 5-10%)

Responsibilities

• Contribute to the authoring of protocol and ICF documents/amendments, presenting to development teams and governance committees (e.g., DEC, SSC) as required.
• Works closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
• Performs clinical/medical data review, including clinical safety monitoring and activities and procedures that ensure patient safety
• Perform manual coding of concomitant medications and adverse events as needed.
• Identify study and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
• Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution.
• Conduct literature reviews as needed for the interpretation of study data and development of next steps.
• Perform review, analysis, and interpretation of study results and ensure appropriate data review and accurate data reporting.
• Collaborate with the Clinical Leader to establish and oversee the management of the study steering committee, data monitoring committee, data safety monitoring board, independent response adjudication committee, as applicable etc.
• Write/review content for program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• In conjunction with the Team Leader/Clinical Leader/CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Serve as clinical science representative on cross-function teams as assigned.

Skills/Knowledge

• Demonstrated ability to review and summarize oncology study data, including experience in preparing and presenting data.
• Thorough understanding of the oncology drug development process from pre-IND through registration and post-registration required
• Broad understanding of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization) in oncology.
• Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy of oncology products.
• Successful track record for the ability to interpret, analyze, and present oncology clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism

Qualifications

• Basic Life Science degree or equivalent and at least 5 years of experience at a pharmaceutical, CRO, or biotechnology company
• 3+ years’ experience in drug development as a clinical scientist or related role.
• Advanced degree (e.g. MS, PharmD., PhD) or equivalent experience, is preferred
• Experience in solid tumor oncology is required.
• Proficient with Microsoft Word/Excel/PowerPoint, EDC systems (e.g. Medidata RAVE), and data review tools (e.g., patient profiles, report generating tools)
• Knowledge of GCP, ICH Guidelines and current US FDA regulations.

Menarini Stemline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range: $175,000 - $250,000

• Position can be Associate Director or Director level. Compensation and title commensurate with experience.