Clinical Trial Risk Based Monitoring Jobs in Michigan

The Manager, Clinical Sciences, Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager leads 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. The Manager reports to either Associate Director or Director, Clinical Sciences and collaborates closely with Medical Director (MD) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

As a Manager, a typical day may include the following:

• Member of the Clinical Study Team and Global Clinical sub-team

• 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

• Develops/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

• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets

• Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments

• Assists with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support development of regulatory documents; may perform quality review

• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety

• Contributes to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority). Presents data and information to external investigators (SIV) and internal collaborators

This role may be for you if:

• Possess demonstrated knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrate solid medical writing skills

• Proven ability to influence within team and may influence across functionally

• Exhibit strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills

• Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways

To be considered for this position, you must have a minimum of Bachelor's Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). We are seeking a minimum of 3 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. You have a basic knowledge of oncology or hematology therapeutic areas as well as a proven track in clinical trial process improvements. We need an individual with demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Resolves novel problems requiring creative application of advanced skill, training, and education.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)