Associate Director, Clinical Operations

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from DP1 and up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies).
Primary Responsibilities For Role
  • Develops and manages clinical development program plans (e.g., strategies, budgets, timelines).
  • Provides clinical input/review to clinical documents and ensures the integrity of clinical data prior to submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports).
  • Manages clinical timelines, budgets, and resources against the approved CDP in collaboration with contract manager.
  • Oversees third party vendors (e.g., contract research organizations (CROs), central labs) and trains them on SOPs, as necessary. Manages the vendor's performance, including on time study completion, budget adherence, and quality deliverables along with the senior management.
  • Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection)
  • Drafts clinical components for DP1-DP5 gates and liaise cross-functionally to provide clinical input on all development stages (DP1-DP5) and TPP, as necessary.
  • Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
  • Collaborates with Manager, Clinical Supplies to ensure timely manufacturing, packaging, labeling, shipping of clinical trial supplies for which the incumbent is responsible.
  • Manages responses to audits, as necessary.
  • Develops program/study status presentation materials during internal management and advisory meetings.
  • Maintain awareness of SAEs that are reported
  • Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
  • Manages direct reports through performance evaluations and addressing professional development.
  • Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
  • Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.
  • Participant and contributor to internal and external training for clinical program (e.g. Kick-off meeting, Investigator meeting)
  • Attends cross functional project team meetings.
  • Maintains good knowledge of the literature for the indication being studied and reviews and summarizes relevant literature for the therapeutic area of interest, as necessary.
Knowledge, Skills, & Abilties
Good knowledge of good clinical practices (GCPs), code of federal regulations (CFRs), ICH, and clinical trial management including monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, budgets, and financial tracking. Good project management skills, including effective planning and organizational skills. Good leadership skills in supervising direct reports and defining strategies for efficient program/study execution. Good verbal, written and interpersonal skills as well as motivational, decision-making and issue resolution skills. Good ability to recognize cultural and regional differences that affect medical standards and patient care. Good ability to manage multiple programs/studies. Good ability to prioritize and effectively manage changing priorities.
Education
Bachelor’s degree in life sciences or Master’s degree in biomedical science.
Experience
Typically requires a minimum of 5 years of clinical research experience. (If Master’s degree in biomedical science, equivalency is 2 years of pharmaceutical industry experience in clinical research). Project or technical leadership experience required. Supervisory or management experience preferred.
Equivalency
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Third Party Agency And Recruiter Notice
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : NC-RTP : USNC0001 - RTP NC-Headquarters
Learn more about Grifols

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Grifols
Grifols

Current Openings: 0

Grifols es una compañía global del sector de la salud fundada en 1909, comprometida con mejorar la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y proporcionamos servicios y soluciones sanitarias innovadoras en más de 110 países. Las necesidades de los pacientes y nuestro creciente conocimiento de muchas enfermedades crónicas, raras y prevalentes, a veces muy graves, impulsan nuestra innovación para desarrollar medicamentos derivados del plasma y otros productos biofarmacéuticos que mejoren la calidad de vida de las personas. Los tratamientos que ofrece Grifols son para patologías de una amplia gama de áreas terapéuticas: inmunología, hepatología, cuidados intensivos, neumología, hematología, neurología y enfermedades infecciosas. Grifols, con una plantilla de más de 27.000 personas en más de 30 países y regiones, apuesta por un modelo de negocio sostenible, referente de innovación continua, calidad, seguridad y liderazgo ético. Nuestro trabajo diario genera impacto social y económico positivo en las comunidades en las que estamos presentes, a través de la creación de puestos de trabajo y valor social. Las personas están en el centro de todo lo que hacemos y nos esforzamos por crear una sociedad inclusiva, diversa, justa e igualitaria. Mantener y promover una plantilla que refleje esta realidad conduce a mejorar las relaciones profesionales y nos ayuda a dar lo mejor de nosotros mismos a pacientes, donantes y clientes. En 2022, Forbes reconoció a Grifols como una de las mejores compañías para mujeres trabajadoras (Best Employers for Women), una de las mejores empresas grandes en las que trabajar en EE.UU (America’s Best Large Employers) y una de las 75 mejores empresas para trabajar en España.
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀