- Assist in establishing clinical trial strategies for oncology products under development
- Design, create, and initiate study protocols and necessary documentation in line with project plans and regulations
- Act as the medical monitor for company-sponsored trials
- Provide therapeutic area-specific information to project teams
- Collaborate with the internal safety group in analyzing safety data
- Analyze and interpret clinical trial data and prepare reports for regulatory agencies
- Medical degree with specialization or eligibility in Oncology or Hematology/Oncology
- 10 years of relevant post-residency experience
- OR equivalent combination of education and experience
- Extensive experience in drug development within biotechnology or the pharmaceutical industry
- Hands-on experience in designing, executing, and reporting controlled clinical trials in oncology
- Familiarity with advanced science related to clinical oncology
- Proven ability to work effectively in a cross-functional environment
- Develop technical and business solutions to complex problems
- Strong interpersonal, influencing, and communication skills
- Excellent organizational and time management abilities
- Establish and maintain relationships with key opinion leaders
- Handles complex problems requiring in-depth evaluation
- Engages in abstract problem-solving across business functions
- Exercises independent judgment in achieving results
- Ensures budgets and schedules comply with corporate requirements
- Interacts with executives and major customers regularly
-
Sr. Clinical Development Medical Director
4 weeks ago
System One King of Prussia, United StatesTitle: Sr. Clinical Development Medical Director · Location: Must be local to King of Prussia, PA · Type: Perm · Start Date: ASAP · Must have · + Oncology · + Early Phase Development · + MD · + Strong industry background · + Prefers someone who is not a contractor. · Sr. Clini ...
-
Sr. Clinical Development Medical Director
1 week ago
Joulé King of Prussia, United StatesTitle: Sr. Clinical Development Medical Director · Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today. · Location: Must be local to King of Prussia, PA · Type: Perm · Start Date: ASAP · Must have · Oncology · Ear ...
-
Sr. Clinical Development Medical Director
1 week ago
Joulé King of Prussia, United StatesTitle: Sr. Clinical Development Medical Director · Location: Must be local to King of Prussia, PA · Type: Full time permanent - direct with the sponsor client · Start Date: ASAP · Must have · Extensive Oncology clinical trial experience · Robust Phase III Oncology clinical trial ...
-
Clinical Development Director
3 days ago
GlaxoSmithKline Collegeville, United StatesSite Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence · Posted Date: Apr · Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, ...
-
Medical Director, Clinical Development
3 weeks ago
Harmony Biosciences LLC Plymouth Meeting, United StatesHarmony Biosciences is recruiting for a Medical Director, Clinical Development & Strategy in our Plymouth Meeting, PA location. · In this role you will be responsible for leading and driving input into clinical development strategy for key programs and studies for Harmony Biosci ...
-
Late-Stage Clinical Development Leader
1 week ago
Organon Plymouth Meeting, United StatesJob Description · The Position · The Head of the Late-Stage Clinical Development organization is a member of the Organon Research and Development (R&D) Leadership team, reporting to the Head of R&D and Chief Medical Officer, and is accountable for:The leadership of the following ...
-
Late-Stage Clinical Development Leader
4 weeks ago
Organon Plymouth Meeting, United States Full timeJob Description · The Position · The Head of the Late-Stage Clinical Development organization is a member of the Organon Research and Development (R&D) Leadership team, reporting to the Head of R&D and Chief Medical Officer, and is accountable for: · The leadership of the followi ...
-
Director Clinical Development
4 weeks ago
Teva Pharmaceutical Industries West Chester, United StatesWho we are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wor ...
-
Director Clinical Development
1 week ago
Teva Pharmaceuticals West Chester, United StatesDirector Clinical Development - Immunology · Date: Apr 28, 2024 · Location: · West Chester, United States, Pennsylvania, 19380 · Company: Teva Pharmaceuticals · Job Id: 54548 · **Who we are** · Together, we're on a mission to make good health more affordable and accessible, to he ...
-
Director Clinical Development
3 weeks ago
Teva Pharmaceuticals West Chester, United StatesDirector Clinical Development - Immunology Date: Apr 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 54548 Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around ...
-
Sr Director Clinical Development
4 weeks ago
Teva Pharmaceuticals West Chester, United StatesThe opportunity · The Senior Director, Clinical Development is responsible for providing the medical input and medical oversight for an immunology or neuroscience clinical development program(s). Strategic responsibilities include scientific support design and execution of clinic ...
-
Global Early Clinical Development Manager
1 week ago
ICON Clinical Research Blue Bell, United StatesAs a Global Early Clinical Development Manager you will play a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions. You will be a dedicated resource to one of our clients, embedded in their ...
-
Director-Clinical development, Ophthalmology
5 days ago
Exegenesis Bio Inc Ambler, United StatesJob Description · Job DescriptionJob Title: Director- Clinical Development, OphthalmologyReports to (Title): CEO · Location: Remote · Exempt/Non-Exempt: Exempt · Direct Reports: No · Department: Clinical Science · Job Summary: Responsible for driving the US or global clinical d ...
-
Sr Director Clinical Development
1 week ago
Teva Pharmaceutical Industries West Chester, United StatesWho we are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wor ...
-
Sr Director Clinical Development
4 weeks ago
Teva Pharmaceuticals West Chester, United StatesSr Director Clinical Development · Date: May 1, 2024 · Location: · West Chester, United States, Pennsylvania, 19380 · Company: Teva Pharmaceuticals · Job Id: 54250 · **Who we are** · Together, we're on a mission to make good health more affordable and accessible, to help millions ...
-
Nemours Wilmington, United States OTHERNemours is seeking an Advanced Clinical Pathways Development Specialist to join our Nemours Children's Health team in Wilmington, Delaware. · In alignment with our Strategic Plan, Nemours is shifting our clinical focus toward a care model that emphasizes clinical pathways (former ...
-
Late-stage Clinical Development Leader
1 day ago
Organon Plymouth Meeting, United States**The Position** · The Head of the Late-Stage Clinical Development organization is a member of the Organon Research and Development (R&D) Leadership team, reporting to the Head of R&D and Chief Medical Officer, and is accountable for: · - The leadership of the following teams: Gl ...
-
Director Clinical Development
2 weeks ago
Teva Pharmaceuticals West Chester, United StatesWho we are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wo ...
-
Jefferson Health Philadelphia, United StatesReporting to the Senior Vice President (SVP), the Assistant Vice President (AVP) of Orthopaedics and Clinical Programs will provide leadership and day-to-day management for all of Orthopaedic and Clinical Program development related programs for all divisions in Orthopaedic Surge ...
-
CSL Behring LTD King Of Prussia, United StatesThe Opportunity · CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. · Wit ...
Executive Medical Director, Clinical Development - King of Prussia, United States - Exelixis
Description
DESCRIPTION - EARLY-STAGE CLINICAL TRIAL LEAD
In collaboration with the Exelixis clinical teams, **the main focus is to lead and carry out early-phase clinical trials** for oncology products under development. **Playing a key role in developing and executing clinical studies** while assisting in interpreting study findings. Responsible for establishing and approving scientific approaches for designing and implementing clinical protocols, data collection systems, and final reports. **Also involved in recruiting clinical investigators** for research studies. To ensure compliance, responsible for adverse event reporting and monitoring safety obligations. Additionally, coordinates and prepares reports for submission to the FDA. Monitors protocol adherence and determines study completion.
RESPONSIBILITIES:
QUALIFICATIONS AND SKILLS:
SKILLS AND ABILITIES:
JOB COMPLEXITY:
WORKING CONDITIONS:
If you thrive in a dynamic environment and enjoy working with motivated and enthusiastic professionals, **this could be the perfect career opportunity for you**. Exelixis offers competitive compensation reflecting labor costs across various U.S. regions, with additional adjustments based on specific work locations. Join us for a rewarding career where your valuable contributions are recognized and rewarded. **Grow your career with Exelixis today**.
DISCLAIMER
The above job description provides a glimpse into the work performed within this role and **does not encompass all duties, responsibilities, and qualifications** of the job.
Exelixis is **proud to be an Equal Opportunity Employer**, advocating a workplace free of discrimination based on various factors such as race, gender, religion, age, or any other protected class. **We value diversity and inclusion**.
