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Job Title: Temp - Associate Director, Clinical Sciences, Hematology
Location: Remote, US
Contract: Initial 6-12 month contract
Job Description:
The Temp Associate Director, Clinical Scientist contributes to the development, evaluation, planning and execution of hematology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Works 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. Reports to the Director, Clinical Sciences Hematology, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.
As a temp Associate Director, a typical day may include the following:
- May function as Clinical Scientist for program, and/or as delegate of Therapeutic area Clinical Scientist
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
- Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
- Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
- Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments. Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
- Contributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
- Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
- Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
This role may be for you:
- Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence across functionally.
- Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; Identifies opportunities for process improvements.
- You possess strong cross-functional management, interpersonal skills, and strong attention to detail.
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $80.00 - $120.00 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.