- Medical/scientific responsibility for compound-level right-to-operate elements, including Investigator Brochures, Safety Update Reports, Risk Management Plans, and product labelling
- Medical/scientific responsibility in interactions with internal cross-functional partners and senior leaders, external medical/scientific investigators/experts/leaders, and Health Authorities
- In collaboration with Compound Development and Disease/Pathway Area Stronghold teams, development/execution of: o Disease/pathway area strategies including indication/target prioritization, future treatment paradigms incorporating treatment sequences and combinations, precision medicine/patient stratification
- Medical/scientific responsibility in business development activities, including assessment/due diligence for external program/asset partnering opportunities
- Participate in cross-departmental/cross-functional projects with broad Janssen impact
- Strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs
- Strong potential to work, collaborate, communicate, and influence in a cross-functional matrix environment, delivering Immunology TA strategies with a one-team, one-portfolio mindset
- Foundational understanding of clinical research / drug development, with strong potential to drive innovation and maintain high standards of research conduct
- Develop and maintain an external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio
- Represent Janssen Immunology in a highly professional manner internally and externally
- MD, DO, or MD/PhD is required
- Relevant (at least 4 years) experience in clinical care/research for complex diseases
- Board certification or eligibility in Gastroenterology or Immunology would be strongly preferred.
- Experience in immune-mediated inflammatory disease is preferred.
- Board Certification or eligibility in Gastroenterology would be strongly preferred
- Track record of producing results in a matrix-based environment
- Approximately 10% to 20% annual travel may be required (domestic and international)
-
Director-Clinical development, Ophthalmology
3 weeks 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 ...
-
Medical Director, Clinical Development
1 week 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
2 weeks ago
Organon & Co 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 follo ...
-
Late-Stage Clinical Development Leader
2 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 ...
-
Eurofins Horsham, United StatesJob Description · Job DescriptionCompany Description · Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustaina ...
-
Director Clinical Development
2 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
2 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 he ...
-
Director Clinical Development
2 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
2 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 ...
-
Sr Director Clinical Development
2 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 ...
-
Sr Director Clinical Development
2 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 ...
-
Regional Clinical Development Director
3 weeks ago
Kaleidoscope ABA Therapy Services Cherry Hill, United StatesJob Description · Job DescriptionLocation: Cherry Hill, NJ 08002Date Posted: 5/17/2024Category: Center BasedEducation: Master's Degree · Regional Clinical Development Director · Are you a dynamic and visionary Board-Certified Behavior Analyst (BCBA) with a passion for leadership ...
-
Regional Clinical Development Director
3 weeks ago
Kaleidoscope ABA Therapy Services Cherry Hill, United StatesJob Description · Job DescriptionLocation: Cherry Hill, NJ 08002Date Posted: 5/12/2024Category: Center BasedEducation: Master's Degree · Regional Clinical Development Director · Are you a dynamic and visionary Board-Certified Behavior Analyst (BCBA) with a passion for leadership ...
-
Sr. Clinical Development Medical Director
2 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 ...
-
Late-Stage Clinical Development Leader
1 week ago
Organon Plymouth Meeting, United StatesJob Description · Job 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 leaders ...
-
Executive Medical Director, Clinical Development
3 weeks ago
Exelixis King of Prussia, United StatesSUMMARY/JOB PURPOSE: · In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early-stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study ...
-
Exam. Health and Nursing Caregiver
1 week ago
Velocity Enterprises Fort Montgomery, United States100% Team Spirit – 690 Employees – 360 Beds – 6,700 Patients per Year – 7 Sister Clinics · Start Date: As soon as possible · MY TEAM. MY PATH. · Whether in nursing, therapy and medicine, or in service and administration: Our work is characterized by the exchange of our skills and ...
-
Mobile Veterinarian
6 days ago
Lap of Love Willow Grove, United States Full timeLife is HAPPIER at Lap of Love Join Lap of Love as an In-Home, Associate Veterinarian in Willow Grove · Are you ready for a change of pace from in-clinic practice? Looking to reconnect with pet families and provide the kind of service you'd always envisioned by having generous ap ...
-
Clinical Development Director
3 weeks ago
GSK Collegeville, United States**Site 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 suppo ...
-
Director Clinical Development
4 days 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 ...
Associate Director, Clinical Development - Spring House, United States - J&J Family of Companies
Description
Associate Director, Clinical Development - Gastroenterology WDescription
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at
Johnson and Johnson is recruiting for an
Associate Director, Clinical Development - Gastroenterology , to be located in Spring House, PA.
As Immunology Leaders, we know immunology is vital to human health.
Driven by a relentless focus on patient unmet needs, we will redefine treatments for immune diseases by delivering transformational and accessible therapies and regimens to patients with immune-mediated disease.
For more than two decades we have been a world leader in the development of transformational medicines, establishing one of the strongest, first-in-class portfolios and pipelines in the industry, including the first tumor necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and IL-23 inhibitors.
We tirelessly push the boundaries of science and creativity, applying our deep disease insights, novel pathway science, new technologies, and treatment modalities to restore immune homeostasis.
Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo.Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
POSITION OVERVIEW
The Associate Director, Clinical Development is part of the Development Physician team at Janssen Immunology, with clinical development and medical/scientific responsibility for Phase 2 and 3 programs, and providing applicable disease area expertise (including Gastroenterology for the Therapeutic Area [TA]).
The Associate Director, Clinical Development is a key member of cross-functional teams focused on the creation and execution of integrated clinical development plans which seek to produce transformational and accessible therapies for patients with immune-mediated inflammatory disease.
The role involves close partnership with project Clinical Scientists and extensive collaboration with colleagues across disciplines, including Discovery, Translational Science & Medicine, Clinical Pharmacology, Biostatistics, Data Science, Medical writing, Clinical Operations, Global Medical Safety, Regulatory Affairs, Quality, Medical Affairs, Commercial and Market Access.
Beyond individual internal drug development programs, the Associate Director, Clinical Development also contributes to innovation initiatives in disease/pathway areas, drug development processes, and external partnering/business development.
The position will support clinical development strategy, and clinical trial protocol design, development, and execution.The position will also have a leadership role in the conduct of clinical trials, investigator meetings, regulatory interactions, and study and submission document writing.
The successful candidate will have strong communications skills, relevant clinical and matrix workplace experience, and a high degree of curiosity, flexibility, innovation, entrepreneurship, and drive to address unmet medical needs for patients.
RESPONSIBILITIES:
* Medical/scientific responsibility for Phase 2 and 3 clinical trials/programs, including: o Design:
concepts, project plans, protocols, case report forms, operational and analytic plans
o Execution:
regulatory/Ethics Committee applications, start-up, enrollment, medical monitoring, database lock, close-out activities
o Analysis:
interpretation of clinical and scientific data
o Reporting:
internal communications, external scientific disclosure, regulatory filings (including marketing applications and associated activities)
EXPECTATIONS
The successful candidate will have a passion to drive programs into diverse immune-mediated inflammatory disease indications, based on scientific rationale and unmet medical needs.
General expectations
Qualifications
In particular:
Primary Location NA-US-Pennsylvania-Spring House
Organization Janssen Research & Development, LLC (6084)
Relocation Eligible: Yes - Within Country
Travel Yes, 10 % of the Time
Job Function Clinical Development & Research & MD
Req ID: W
