Temp-Manager, Medical Affairs, Immunology

Location
Tarrytown, NY, United States
Posted
Jun 15, 2019
Ref
16707BR
Required Education
Masters Degree/MBA
Position Type
Contract
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Qualified Manager/Sr manager with experience in supporting clinical development or real-world studies in the pharmaceutical/biotechnology sector, academic or clinical setting. This manager will work closely with Data Generation Lead, Medical Directors, Study Directors and other members of the cross-functional team on all activities related to post-approval studies, and will contribute to post-approval data generation, such as Phase 4 clinical trials and observational studies.

Job Duties:

Work closely with the data generation lead and supports the cross-functional study team on the following activities, including but not limited to:

• Provide background searches (e.g., literature, internal data sources, etc.) in support of study rationale and scientific/clinical endpoints as per Med Affairs strategy

• Contribute to the writing of Clinical Study Expanded Synopsis (ES) and Clinical Study Protocols (CSPs) and amendments

• Contribute to the development of electronic case report forms (eCRF), informed consent form (ICF) masters, study manuals, and other study documents

• Assist with identifying key internal and external collaborators/advisors, organizes consultations with subject matter experts

• Represent Medical on cross-functional clinical study teams, contributes medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables:

• Review study related documents such as: medical monitoring plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT

• Train, support, and where applicable oversee study team and CRO personnel regarding clinical and operational aspects of trial

• Prepare study progress reports and study related presentations for internal and external audiences

• Participate in the review of study data, assess data completeness, identify trends, data quality issues or data risks; inform the data generation lead, study director and study team of critical design or operational gaps, craft and implement mitigation strategies

• Participate in data analysis and help develop ad-hoc data summaries (e.g., graphs and summary tables) based on statistical outputs

• Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, etc.

• Organize steering committees, advisory boards, and data safety monitoring boards as needed

• Ensure Study Team compliance with FDA, EMEA, ICH and GCP guidelines, as well as all applicable SOPs

Managerial responsibility and related expectations:

• Identify with and actively communicate/apply company values on a consistent basis.

• Demonstrate Core Competencies as defined for Regeneron managers on a consistent basis.

• Work in a results-oriented manner to plan and execute activities supporting team, brand and corporate goals, and core business strategy.

• Take leadership role and/or participate as an active member on cross functional teams.

• Demonstrate excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside Regeneron.
Knowledge and Specialized Skills:

• Possess strong scientific knowledge and analytical skills, with emphasis on clinical/life sciences

• Understand the clinical trial process with demonstrated ability to support clinical programs

• Understand the regulatory framework and requirements applicable to clinical trials.

• Demonstrate an organized and efficient approach to problem solving and evidence-based decision making.

• Demonstrate self-motivation and initiate workstreams and collaborations with cross-functional team(s) to support strategic plans and objectives.

• Demonstrate strong interpersonal, verbal and written communication skills.

• Understand the roles and capabilities of study team members, and collaborate effectively with cross-functional colleagues to achieve project objectives.

• Able to form strong and constructive internal and external professional relationships.

• Demonstrate proficiency in presenting clinical study information to internal and external audiences.

• Able to take an active leadership role and guide cross-functional teams towards desired outcomes.

• Ensure adherence to all relevant industry regulations and guidelines, such as OIG and The Company's Code of Business Conduct and Ethics.

Requirements:

• Education: Master's or PhD degree in biomedical sciences, MPH, PharmD, DDS, DMD, or other advanced degrees in biomedical fields

• 2-5 years of hands-on experience supporting clinical development or real-world studies

• Effective communications (verbal & written) and presentation skills are essential

• Must be flexible, adaptable, and able to work productively in a fast-paced collaborative environment

• Critical thinking and sound decision-making skills

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.