Medical Affairs Operations Senior Manager

Medical Affairs Scientist, Snr MgrCompany profile:Founded in 2012, Company is an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs) targeting major types of hematological malignancies and solid tumors.

The Company’s ADCs are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD) based warheads via a chemical linker. The Company currently has five programs in eight clinical studies, including one registrational trial.

The Company has raised $455 million since it was founded and has operations in Lausanne Switzerland (Head Office), London UK (R&D), New Jersey US (Clinical) and San Francisco US (CMC manufacturing).

().Position Overview:The Medical Affairs (MA) Scientist will be a member of the MA Strategy and Research team.  The position will contribute to the execution of programs during development, launch, and post approval  for ADCT products.  This includes programs for, but not limited to, investigator initiated trials (IITs), cooperative group studies, registries and post-approval research.  The position will support content development for advisory boards, Health Care Providers’ interactions, and attendance at individual meetings with outside experts as well as Congresses.  The position will focus on the launch of the lead compound, Loncastuximab tesirine, but may also work on other ADCT portfolio products across different developmental stages.   The position partners with Program leaders and collaborates with other ADCT functions to successfully execute MA evidence generation programs.Reporting to the Associate Director, MA Strategy & Operations, the MA Scientist will be able to successfully perform the responsibilities as described below, and/or ensure the successful completion if delegated.Key Job Responsibilities: Work with the Associate Director and the MA Head of Medical Operations to generate budgets for MA evidence generation programs such as, but not limited to, IIT and post approval research.Assist the Associate Director to track and manage IITs submissions through internal processes to the completion of the study, including the day-to-day management of Strategy & Research deliverables timelines.

Follow up to ensure successful execution of the program and individual studies.Engage external stakeholders to complete IIT protocols.Contribute to, represent and or lead MA activities related to the development and execution of early access programs.Contribute to the development and maintenance of core MA documents.Assist the Associate Director with activities related to medical support for Commercial.Ensure compliant execution of advisory boards and participate in related content development.Support the medical affairs programs and leaders regarding ad-hoc requests from leadership for information about medical programs.Work in partnership with other MA functional areas (e.g., Field Medical & Publications, HEOR, MI, etc.) to coordinate input for post approval research.Provide operational oversight of vendors, as required.

Author and/or review MA Standard Operating Procedures (SOPs).Assist with content development as needed for Publication activities.Collaborate with MA partners to assure the accuracy of manuscripts or abstracts developed with input from MA.Requirements:          Bachelor’s degree or higher, in biological sciences or relevant field preferred.Minimum 5 years experience in the pharmaceutical, clinical research organizations or healthcare academic experience preferred.Oncology experience desirable, but other therapeutic areas would be considered.Demonstrated ability to manage day to day operations, budgets, and timelines.Demonstrated project management expertise.Demonstrated ability to work both independently and in a team matrix management structure.Strong writing and analytic skills, experience writing and presenting health-related information. Exercise sound judgment and be able to embrace change.Skilled in the use of the MS suite of applications, including MS Project.Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required).Ability to travel.Type: direct hire