Senior Medical Writer Jobs in Delaware

Overview:

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity.

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary function)

The Senior Medical Director will support the development and execution of the strategy and plans of one or more development program, in collaboration with the project team. The individual will be involved with the full scope of clinical drug development activities from preclinical research through Phase 4 studies. The employee will be an integral member of the project team and may serve as the clinical lead for individual asset(s) and/or provide critical and strategic input into the clinical aspects of late phase studies.

Essential Functions of the Job (Key responsibilities)

• Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.
• Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
• Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with and select investigators for clinical studies and post approval support (US and globally) and supply information on resource requirements to relevant groups.
• Have accountability for delivery of clinical study plan along with clinical operations lead that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices.
• Lead the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols.
• Contribute to the development of clinical development strategy for development assets.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• MD with advanced clinical training
• Minimum 5 years' experience in the pharmaceutical industry or related field
• Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP)
• Experience in late-stage drug development (Phase 2, 3, and 4)
• A credible 'thought leader' capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency.
• Excellent communication skills and written, verbal and presentation skills.
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Experience includes a clinical leadership role on a drug development project team
• Self-motivation and entrepreneurial spirit.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Pay Range: USD $324,800.00 - USD $391,700.00 /Yr.