Senior Director, Clinical Development
Asahi Kasei —Cary, NC
- $300,000 - $350,000 a year
- Full-time
- Hybrid work
- Medicine
- 7 years
- Business development
- Health insurance
Senior Director
State of North Carolina - Public Instruction —Wake County, NC
- $121,140 - $140,779 a year
- Full-time
- Computer science
- Computer Science
- System design
- Loan forgiveness
14d
MEP Estimator II
McGough Construction —Raleigh, NC
- AutoCAD
- Construction site
- Engineering
Director - Energy and Physical Plant
Wake County Public School System —Raleigh, NC
- Weekends as needed
- 5 years
- Engineering
- Office
10d
Project Executive (Life Science)
Consigli Construction —Raleigh, NC
- $200,000 - $265,000 a year
- Full-time
- Construction site
- Engineering
- Public speaking
Quick Apply
Associate Clinical Director (BCBA)
Autism Learning Partners —Garner, NC
- From $105,000 a year
- Psychology
- Senior level
- Continuing education credits
- Mileage reimbursement
Quick Apply
8d
Project Executive (Life Science)
Consigli Construction —Durham, NC
- $200,000 - $265,000 a year
- Full-time
- Construction site
- Engineering
- Public speaking
Quick Apply
Clinical Director / BCBA
Wholesome Care ABA —Apex, NC
- $80 - $120 an hour
- Part-time
- Hybrid work
- Master's degree
- Children
- Organizational skills
- Health insurance
- Paid time off
Quick Apply
1d
Sr Medical Director - Immunology/Rheumatology
Syneos - Clinical and Corporate - Prod —North Carolina
- $146,000 - $332,000 a year
- Full-time
- Team management
- Senior level
- Employee stock purchase plan
- Health insurance
Director, Security Architecture & Engineering
Relias US —Morrisville, NC
- $180,000 - $200,000 a year
- Full-time
- Hybrid work
- Azure
- Computer Science
- 5 years
- Health insurance
- Paid time off
Quick Apply
Senior Lead Board Certified Behavior Analyst (BCBA)
Learn & Leap Autism Center —Cary, NC
- $85,000 - $90,000 a year
- Full-time
- Background check
- 3 years
- Master's degree
- Relocation assistance
- Health insurance
Quick Apply
Coordinating Teacher - Regional Achievement and School Support, Math
Wake County Public School System —Cary, NC
- Weekends as needed
- School experience
- Teaching Certification
- Mid-level
Mechanical Project Engineer
WB Engineers+Consultants —Raleigh, NC
- $85,000 - $140,000 a year
- Full-time
- 5 years
- Team management
- Mentoring
Senior Vision Software Engineer
Targan Inc —Raleigh, NC
- Full-time
- Computer science
- Azure
- Computer Science
Quick Apply
Medical Director
VOANS, Senior Community Care of NC —Durham, NC
- $248,000 - $298,000 a year
- Full-time
- Medicine
- Administrative experience
- Driver's License
- Wellness program
- Paid holidays
Quick Apply
Pharmacy Director
Clinical Management Consultants —Durham, NC
- $125,030 - $160,280 a year
- Full-time
- Acute care
- Inpatient
- Mentoring
- Health insurance
- Dental insurance
Director, Education and Law
North Carolina Justice Center —Raleigh, NC
- $100,000 - $106,000 a year
- Online Application
- Hybrid work
- Mentoring
- Contracts
- Fair chance
- Health insurance
- Dental insurance
14d
Sales and Marketing Manager
AfterLight: The Gallery at Endswell —Chapel Hill, NC
- $55,000 - $65,000 a year
- Full-time
- Customer service
- Mid-level
- US work authorization
- Health insurance
- 401(k)
Quick Apply
Executive Director
Brookdale Senior Living Inc. —Durham, NC
- Nights as needed
- Writing skills
- 3 years
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
Quick Apply
12d
Executive Director (Full-Time) - Carolina Reserve of Durham
Navion Senior Solutions —Durham, NC
- Full-time
- Computer literacy
- Business development
- US work authorization
- Disability insurance
- Dental insurance
Quick Apply
6d

I want to receive the latest job alert for senior development director in raleigh nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

senior development director jobs near raleigh nc

Life Science Consultant jobs in Durham, NC

Senior Estimator jobs in Raleigh, NC

Senior Medical Director jobs in North Carolina

Medical Director jobs in Durham, NC

Mechanical Engineer jobs in Raleigh, NC

Director jobs in Raleigh, NC

Senior Software Engineer jobs in Raleigh, NC

Director Of Pharmacy jobs in Durham, NC

Executive Director jobs in Durham, NC

Board Certified Behavior Analyst jobs in Cary, NC

Life Science Consultant jobs in Raleigh, NC

Senior Director jobs in Wake County, NC

Mathematics Teacher jobs in Cary, NC

Logistics Manager jobs in Austin, TX

Sales And Marketing Manager jobs in Corning, NY

Sales And Marketing Manager jobs in Sunnyvale, CA

Logistics Manager jobs in New Jersey

Restaurant General Manager jobs in Austin, TX

Sales And Marketing Manager jobs in Fairfax, VA

Sales And Marketing Manager jobs in Morgan Hill, CA

Senior Director, Clinical Development

Asahi Kasei -
Cary, NC

Apply Now

Job Details

Full-time
$300,000 - $350,000 a year

Benefits

Health insurance

Qualifications

Statistics
Medical writing
Project development phase management
Biostatistics-based research
ICH guidelines
Product development
Project management experience in healthcare
Productivity software
Clinical quality assurance standards
Cross-functional collaboration
Clinical data analysis
Translational research
Cross-functional team management
Task assignment
Pharmaceutical research experience
Cross-functional communication

Full Job Description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

The Sr. Director, Clinical Development is responsible for ethical, medical, and scientific rigor in supporting the development, conduct, and reporting of assigned clinical development portfolio across all stages of drug development and commercialization. This position is responsible for medical and scientific quality in the design, planning, initiation, and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. As a leader of the Clinical Development department, this position may have line management accountability for Clinical Development staff.

Key Responsibilities

Prepare clinical development plans according to the nature of the clinical project and its objectives: exploratory research, support a marketing authorization application, marketing and commercialization support, new indication, etc., ensuring that all aspects of ICH-GCP, medical devices guidelines/regulations and agreed quality standards are complied with at all times.
Responsible for overall management of a product portfolio (i.e., multiple indications for the same product), as needed, based on the clinical development plan.
Oversee protocol development from concept to final protocol. Protocol execution including interaction with key opinion leaders/ investigator(s). May serve as sponsor contact for key study sites on protocol related topics.
Serve as an escalation point for the Clinical Development team; participates in CRO Executive Governance meetings, as required.
Serve as a mentor and provides line management for junior level staff, if required.
Budgetary responsibilities for programs direct reports are overseeing.
May serve as Medical Monitor or point of contact for CRO Medical Monitor for assigned clinical trials overseeing participant inclusion into the study. Provides back-up Medical Monitoring support for direct reports, as required.
Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research, clinical development plans, operational and regulatory documents, including but not limited to study synopses, protocols, CRFs, informed consent templates, feasibility assessments, statistical analysis plans, clinical sections of regulatory documents ( e.g., IND, MAA, NDA, PIP, DSUR, annual reports, regulatory designations, etc.), key study plans, and clinical study reports to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency.
Lead responses to competent authority questions, as requested.
Oversee study data reviews, liaise with data safety monitoring committees or other protocol directed committees, data analysis, and clinical study report authoring.
Participate in the multi-disciplinary project team as the responsible individual of the project clinical development and presentation of the clinical trial results, aligned with Program Management when appropriate (teams and committees).
Oversee/conduct ongoing medical and scientific review of clinical trial data with clinical scientific expert(s).
Oversee creation and translation of Target Product Profile (TPP) into clinical strategy.

Manage Key Opinion Leader and Medical Advisory Board interactions. Identify Key Opinion Leaders, as needed.
Responsible for study medical/ safety data aspects and risk-benefit assessments supported by Pharmacovigilance team.
Ensure study quality and manage internal clinical activities. Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study plans and performance/quality and lead risk mitigation activities to ensure the timely delivery of study results and reports that comply with the applicable quality requirements. Escalate areas of concern to Clinical Development and Clinical Operations Heads as appropriate.
Support business development activities, due diligence processes, and market access related to clinical development.
Supervise clinical trial related activities delegated to /shared with Clinical Project Manager.

Required Skills and Qualifications

Education/Training:

MD, DO, PhD, PharmD or equivalent degree or experience.

Previous Experience:

At least 7-10 years of demonstrated clinical research and clinical development experience required, and experience working with all drug/medical device development phases, Infectious Disease experience preferred.

Abilities and Skills:

Working knowledge of the assigned disease area with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trial(s).
Working knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines.
Working knowledge of clinical trial design and statistics.
Understanding of scientific methods and tools used in early clinical development, biomarkers, translational modeling, biostatistics, and relevant clinical trial landscape.
Strong communication and oral presentation skills with the ability to work in a cross-functional and global organization.

Highly organized and able to work within international environments with team members located in different locations/countries. Alignment with our Parent Company’s group philosophy to contribute to life and living for people around the world through its group values and group vision.
Able to seek and understand different perspectives, developing alternative solutions and valuing options suggested by others within the team.
Able to understand and clarify boundaries of responsibility within own role and be able to allocate decision-making authority and task responsibilities to other team members as appropriate.
Able to efficiently manage all tasks required during a study, to track multiple items, and provide guidance on the prioritization of tasks within a study.
Ability to travel domestically and internationally, as required (approximately 25%)
Strong project management and medical writing skills.
Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Pro.

The base compensation range for this role is $300-350K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

#LI-LH1

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

Apply Now

Refine Your Search

senior development director jobs in raleigh nc

Senior Director, Clinical Development

Senior Director

MEP Estimator II

Director - Energy and Physical Plant

Project Executive (Life Science)

Associate Clinical Director (BCBA)

Project Executive (Life Science)

Clinical Director / BCBA

Sr Medical Director - Immunology/Rheumatology

Director, Security Architecture & Engineering

Senior Lead Board Certified Behavior Analyst (BCBA)

Coordinating Teacher - Regional Achievement and School Support, Math

Mechanical Project Engineer

Senior Vision Software Engineer

Medical Director

Pharmacy Director

Director, Education and Law

Sales and Marketing Manager

Executive Director

Executive Director (Full-Time) - Carolina Reserve of Durham

I want to receive the latest job alert for senior development director in raleigh nc

Related Searches

Explore jobs in more locations

Key Responsibilities

Required Skills and Qualifications

The base compensation range for this role is $300-350K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Job Seeker Tools

Employer Tools

Browse

Stay Connected