Talent.com
Associate Director, Clinical Science
Associate Director, Clinical ScienceCelcuity • Minneapolis, MN, US
Associate Director, Clinical Science

Associate Director, Clinical Science

Celcuity • Minneapolis, MN, US
1 day ago
Job type
  • Full-time
Job description

Job Description

Job Description

Salary : $190,000-$230,000 DOE

Title : Associate Director, Clinical Science

Location : Remote

Position Summary :

We are seeking a Associate Director, Clinical Science, who will report to the Executive Director, Clinical Science. You will be responsible for the execution of Clinical Development goals through collaboration with and support of Medical Directors / Physicians and Clinical Development department activities. The Clinical Scientist will represent the Clinical Science group on various teams / sub-teams or other appropriate forums and is expected to perform their responsibilities with a low to moderate level of supervision.

Responsibilities :

  • Review clinical data and ensure quality and consistency in clinical site reporting
  • Develop and review Clinical Development documents including writing, reviewing, adjudication / resolution of cross functional comments and ensuring a high-quality final document. Documents may include abstracts, manuscripts, clinical protocols / amendments, informed consent forms, regulatory documents, and other relevant materials.
  • Develop and review presentations and training materials such as slide decks, posters, or other relevant materials
  • Participate in the relevant Clinical Development Core Team and Clinical Sub-Team meetings as needed
  • Interface with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other members of the extended project team(s)
  • Represent Clinical Science in operational meetings (e.g., Study Management Team meetings) as needed.
  • Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s)

Qualifications :

  • Advanced Science / Clinical Degree is preferred (e.g., PhD, PharmD, MD)
  • 3 or more years clinical trial experience in pharma / biotech industry setting
  • Oncology research experience preferred
  • Data listing review experience is mandatory
  • Experience authoring experimental protocols and / or study results and conclusions
  • Strong understanding of Phase 1 through 4 drug development
  • Excellent comprehension and analytical skills in interpreting scientific research and literature
  • Sound knowledge of scientific and medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant health authority guidelines and regulations
  • Strong understanding of product and safety profiles
  • Working knowledge of the multidisciplinary functions involved in a companys drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs, etc.
  • Excellent time / project management skills : can prioritize multiple tasks to meet short and longer-term goals with high quality standards and in a timely manner
  • Strong oral and written communication skills, including interpersonal interactions, internal and site-directed communications and internal and external presentation skills
  • Good judgment and decision-making skills
  • About Us :

    Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

    Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K / AKT / mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+ / HER2- ABC in the 1L and 2L settings. A Phase 1b / 2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

    Celcuity is an Equal-Opportunity Employer.

    Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $190,000-$230,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidates geography, qualifications, skills, and experience.

    The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

    Notice to Recruiters / Staffing Agencies

    Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

    We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

    Celcuitys receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.

    Create a job alert for this search

    Associate Director Clinical • Minneapolis, MN, US

    Related jobs
    Director, Clinical Science

    Director, Clinical Science

    Minnesota Staffing • Minneapolis, MN, US
    Full-time
    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to ou...Show more
    Last updated: 6 days ago • Promoted
    Associate Director, DSNP Encounter Submissions

    Associate Director, DSNP Encounter Submissions

    Minnesota Staffing • Saint Paul, MN, US
    Full-time
    Associate Director, Business Intelligence.Become a part of our caring community and help us put health first.The Associate Director, Business Intelligence solves complex business problems and issue...Show more
    Last updated: 6 days ago • Promoted
    Area Clinical Director - RN - Senior Living

    Area Clinical Director - RN - Senior Living

    Better Living • Minneapolis, MN, US
    Full-time
    Start a meaningful career as an Area Clinical Director with Better Living!.Make a difference in someone's life every day. At Better Living, we lead with love—creating senior communities wh...Show more
    Last updated: 30+ days ago • Promoted
    Regional Director of Clinical Services (Twin Cities)

    Regional Director of Clinical Services (Twin Cities)

    New Perspective • Minnetonka, MN, US
    Full-time +1
    Regional Director of Clinical Services (Twin Cities).Transform your career in a role that utilizes your nursing, leadership, and interpersonal skills while providing you with the opportunity to mak...Show more
    Last updated: 30+ days ago • Promoted
    Director, Medical Science Liaison, Midwest

    Director, Medical Science Liaison, Midwest

    Celcuity • Minneapolis, MN, US
    Full-time
    Title : Director, Medical Science Liaison.Location : Midwest (Michigan, Wisconsin, Indiana, Illinois and Ohio).We are seeking a Director, MSL who will report to the Senior Director, Eastern US Field ...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Iviva Medical • Eden Prairie, MN, US
    Full-time
    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.Our public benefit purpose is to provide a brighter future for patients through t...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Director / BCBA - Up to 5K Sign on Bonus

    Clinical Director / BCBA - Up to 5K Sign on Bonus

    Accel Therapies • Saint Paul, MN, United States
    Full-time
    Clinical Director (BCBA) Location : Victorville, CA Total Earnings Structure : Competitive base salary $9,000 annual performance bonus (paid monthly) Sign-on bonus of up to $5,000 Schedule : Monday–Fr...Show more
    Last updated: 8 hours ago • Promoted • New!
    Hospice Director, RN

    Hospice Director, RN

    Interim HealthCare of the Twin Cities • Burnsville, MN, US
    Full-time +1
    Work with our amazing Hospice staff to provide efficient and effective delivery of hospice care to our patients.Helps to ensure the Hospice program meets standards of quality and contributes to the...Show more
    Last updated: 19 hours ago • Promoted • New!
    Director, Medical Science Liaison, North Central US

    Director, Medical Science Liaison, North Central US

    Celcuity • Minneapolis, MN, US
    Full-time
    Title : Director, Medical Science Liaison.Location : North Central (Minnesota, Iowa, Nebraska, South Dakota, North Dakota, Kansas, Missouri). We are seeking a Director, MSL who will report to the Seni...Show more
    Last updated: 30+ days ago • Promoted
    Regional Director of Clinical Services

    Regional Director of Clinical Services

    American Baptist Homes of the Midwest • Minneapolis, MN, US
    Full-time
    Begin a rewarding career—join American Baptist Homes of the Midwest as a Regional Director of Clinical Services, where your leadership and clinical expertise will directly impact the quality ...Show more
    Last updated: 25 days ago • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    West Virginia Staffing • Circle Pines, MN, US
    Full-time
    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.Our public benefit purpose is to provide a brighter future for patients through t...Show more
    Last updated: 6 days ago • Promoted
    Program Director

    Program Director

    Rudolph Community and Care • Savage, MN, US
    Full-time
    The Program Director is a key leadership position responsible for the oversight of 47 program sites and the direct supervision of program supervisors. This role ensures high-quality service delivery...Show more
    Last updated: 7 hours ago • Promoted • New!
    Associate Director / Director, Clinical Science

    Associate Director / Director, Clinical Science

    Celcuity • Minneapolis, MN, US
    Full-time
    Title : Associate Director / Director, Clinical Science.We are seeking an Associate Director / Director, Clinical Science who will report to the Executive Director, Clinical Science.You will be responsi...Show more
    Last updated: 12 days ago • Promoted
    Director, Medical Science Liaison, Mountain Region

    Director, Medical Science Liaison, Mountain Region

    Celcuity • Minneapolis, MN, US
    Full-time
    Title : Director, Medical Science Liaison.Location : Mountain Region (Arizona, Colorado, Nevada, New Mexico, Utah, Wyoming, Montana, Idaho). We are seeking a Director, MSL who will report to the Senio...Show more
    Last updated: 30+ days ago • Promoted
    Managing Veterinarian / Medical Director

    Managing Veterinarian / Medical Director

    National Veterinary Associates • ISANTI, Minnesota, United States
    Permanent
    Lead, Mentor, and Grow with Us.Francis Veterinary Clinic | Isanti, MN.Francis Veterinary Clinic is growing fast, and we’re ready to welcome a. If you’re an experienced DVM ready to step into leaders...Show more
    Last updated: 28 days ago • Promoted
    BCBA Clinical Director

    BCBA Clinical Director

    Action Behavior Centers • Blaine, MN, US
    Full-time
    Join Action Behavior Centers as a BCBA Clinical Director.And we commit to a response within 24 hours.Ability to earn more through additional performance-based bonuses. Get rewarded regularly for del...Show more
    Last updated: 8 hours ago • Promoted • New!
    Physician (MD / DO) - Dermatology - $650,000 to $1,000,000 per year in Lindstrom, MN

    Physician (MD / DO) - Dermatology - $650,000 to $1,000,000 per year in Lindstrom, MN

    LocumJobsOnline • Lindstrom, MN, US
    Full-time
    LocumJobsOnline is working with Curative to find a qualified Dermatology MD in Lindstrom, Minnesota, 55045!.Dermatology Physician, Eastern Minnesota. Easy Access to the Minneapolis Airport and Sport...Show more
    Last updated: 13 days ago • Promoted
    Vice President, Clinical Performance

    Vice President, Clinical Performance

    Medica • Minnetonka, MN, United States
    Full-time
    Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences an...Show more
    Last updated: 30+ days ago • Promoted