Medical Affairs Operations Senior Manager
Company: Corps Partners
Location: New Providence
Posted on: April 11, 2021
Medical Affairs Operations Senior Manager Apply Location New
Posted Feb 5, 2021 Medical Affairs Scientist, Snr Mgr 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). (www.adctherapeutics.com ). 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
- 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
- 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
- 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
- Collaborate with MA partners to assure the accuracy of
manuscripts or abstracts developed with input from MA.
- Bachelor's degree or higher, in biological sciences or relevant
- Minimum 5 years experience in the pharmaceutical, clinical
research organizations or healthcare academic experience
- Oncology experience desirable, but other therapeutic areas
would be considered.
- Demonstrated ability to manage day to day operations, budgets,
- 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
- Excellent verbal, written, and interpersonal communication
skills (fluency in written and spoken English is required).
- Ability to travel. Apply Enter your email below to sign up to
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Keywords: Corps Partners, New York , Medical Affairs Operations Senior Manager, Executive , New Providence, New York
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