Director Clinical Development
2 days ago
Vacancies
Director of Clinical Development
Job Introduction
This role is based in Boston, MA, with the option for hybrid or remote work.
Invetx, a Division of Dechra, is a veterinary biotechnology company based in the USA that is engaged in the discovery and development of novel therapeutic proteins for the treatment of important diseases in the veterinary species focused on companion animals. In July 2024 Dechra Pharmaceuticals acquired Invetx. Invetx continues its focus to bring differentiated biotherapeutics for dogs and cats to the Animal Health market as its own Division within the Dechra organization.
The Director of Clinical Development will progress the clinical development of Invetx's portfolio of development projects from nomination as development candidates through to global regulatory approval. The Director of Clinical Development will play a key role in the progression of Invetx's development candidates from proof-of-concept to pivotal clinical studies leading to regulatory approvals. The Director is directly responsible for the design and execution of an assigned portfolio of clinical studies to support the effectiveness and target animal safety technical sections of the NADA/Marketing Authorizations/Product Licenses for assigned development candidates.
Role Responsibility
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- Develop and execute successful clinical strategies to achieve agreed project goals, ultimately leading to regulatory approvals.
- Participate in the creation of development plans, pilot and pivotal protocols and study reports.
- Execute pre-clinical, pilot and pivotal effectiveness and target animal safety studies including study setup, engagement and supervision of CROs, monitoring and study data interpretation.
- Ensure pre-clinical, pilot and pivotal effectiveness and target animal safety studies are executed to a high quality and in accordance with approved plans, internal SOPs, regulatory guidance and legal requirements.
- Assist the VP of Clinical and Regulatory Affairs in the development of appropriate clinical strategies to obtain agreed project goals.
- Participate in the planning of associated clinical studies, timelines and budgets and the execution of clinical studies.
- Collaborate with Discovery and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to clinical development and ultimately, to approval.
- Maintain up-to-date knowledge of the disease areas pertaining to assigned development candidates.
- Identify and source required external resources to execute study.
- Develop budget for approval.
- Develop protocol.
- Identify partner CROs, laboratories, investigators and other required resources.
- Monitor timely execution of study and troubleshoot issues in collaboration with partners.
- Ensure appropriate QA/QC of study.
- Oversee creation of study report.
- Interpret study data and prepare for submission to regulatory agencies.
- In dealing with external collaborators and stakeholders, present Invetx as an innovative and entrepreneurial division of Dechra, setting high professional work standards and pursuing goals with honesty, respect, determination and energy.
- Act with integrity and in an ethical manner.
The Ideal Candidate
- 5+ years of experience in a R&D position within the Animal Health pharmaceutical industry preferably focused on companion animal clinical development.
- 5+ years' experience participating in cross-functional teams.
- Doctor of Veterinary Medicine (DVM) or equivalent.
- Experience in collaborations with CROs and other external vendors.
- Previous success achieving objectives comparable to those of this position.
A high level of proficiency in the following areas is required:
- Verbal and written communication.
- Interpersonal interactions.
- Building strong relationships with relevant stakeholders.
- Participating and performing effectively within cross-functional teams.
- Working in a remote-office environment and in a virtual project team environment.
- Microsoft Office software.
- Planning, managing, and delivering clinical programs leading to regulatory approvals.
- Development of protocols, data capture systems, execution of studies and interpretation of data.
Desirable
- Clinical development experience in the area of veterinary biologics particularly those regulated by the USDA Center for Veterinary Biologics in the USA.
- Experience in the safety assessment of veterinary products.
- PhD, preferably in a veterinary clinical discipline.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.#J-18808-Ljbffr
-
Sr. Director Business Development
2 days ago
Cambridge, MA, United States Clinical Ink Full timeFounded in 2007, Clinical Ink is an innovation-driven eSource solutions company committed to making clinical research easier for sites, sponsors, subjects and regulators. Guided by a mission to eliminate paper documentation in clinical research, Clinical Ink launched SureSource in 2011 – the company’s flagship product and the industry’s first...
-
Associate Director/Director, Clinical Development
16 hours ago
Boston, MA, United States CRISPR Therapeutics Full timeCompany Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare...
-
Director, Clinical Development Melanoma
1 month ago
Boston, MA, United States CK Group Full timeDirector/Snr Director, Clinical Development, Melanoma The Director/Snr Director, Clinical Development will be a MD with a specialisation in oncology, ideally board-certified, and a deep understanding of the solid tumor landscape. Those who are well-versed in the current and emerging treatments for melanoma is preferable and have demonstrated the ability to...
-
Director of Business Development
16 hours ago
California, MO, United States IMA Clinical Research, Inc. Full timeCompany Overview: The Clinical Research Division at The IMA Group is a dynamic hub of expertise and innovation, dedicated to advancing healthcare through clinical trials and studies. Our team of seasoned professionals collaborates with industry leaders, conducting patient-centric research across diverse therapeutic areas. Committed to ethical practices and...
-
Waltham, MA, United States Upstream Bio Full timePosition Summary:We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development. The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent...
-
Clinical Director
4 weeks ago
Norwell, MA, United States Refresh Recovery & Wellness Centers Full timeWe are seeking a dedicated Clinical Director to join our Partial Hospitalization Program for Substance Use Disorders and Mental Health. The Clinical Director will be responsible for overseeing the clinical operations and ensuring the delivery of high-quality patient care. This position offers an exciting opportunity for a healthcare professional looking to...
-
Clinical Director
4 weeks ago
Accord, MA, United States Refresh Recovery & Wellness Centers Full timeWe are seeking a dedicated Clinical Director to join our Partial Hospitalization Program for Substance Use Disorders and Mental Health. Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience. The Clinical Director will be responsible for overseeing the clinical operations and ensuring the...
-
Clinical Director
4 weeks ago
Accord, MA, United States Refresh Recovery & Wellness Centers Full timeWe are seeking a dedicated Clinical Director to join our Partial Hospitalization Program for Substance Use Disorders and Mental Health.Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.The Clinical Director will be responsible for overseeing the clinical operations and ensuring the delivery...
-
Waltham, MA, United States CURE Full timeSenior Medical Director, Clinical Development Senior Medical Director, Clinical Development DynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group. You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and...
-
Medical Director/Clinical Development
2 days ago
Boston, MA, United States Kelonia Therapeutics Full timeHere at Kelonia Therapeutics, we aren’t just a preclinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need. At Kelonia, we've gathered a group of pioneers in cell...
-
Waltham, MA, United States GlaxoSmithKline Full timeSite Name: UK – London – New Oxford Street, Stevenage, Switzerland - Zug, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, WarsawPosted Date: Nov 21 2024MEDICAL DIRECTOR- ONCOLOGY CLINICAL DEVELOPMENT Are you looking to join an ambitious oncology clinical development organisation, focusing on the development of ADCs in the GI...
-
Boston, MA, United States BioTalent Ltd Full timeA global Pharma/Biotech solutions provider is looking to bring on a Director of Business Development with expertise inpre-clinical and clinical services, ideally within Contract Research Organizations(CROs) . This role will focus on expanding our client base in the pharmaceutical, biotech, and CRO sectors, driving revenue growth through strategic...
-
Senior Clinical Trial Manager
4 weeks ago
Boston, MA, United States Clinical Dynamix Full timeSenior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...
-
Cambridge, MA, United States Biogen Full timeJob Description About This Role The position of Associate Medical Director, Clinical Development sits in the Immunology Therapeutic Area – a component of the Clinical Development Organization. The new Associate Medical Director will support one or more development programs involving products in lupus or other autoimmune disease. He/she works in close...
-
Medical Director, Clinical Development
2 days ago
Chicago, IL, United States Tempus AI Inc. Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Clinical Trial Manager, Start Up
4 weeks ago
Boston, MA, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Director Clinical Development
19 hours ago
Parsippany, NJ, United States Tevapharm Full timeDirector Clinical Development - Oncology Date: Sep 13, 2024 Location: Parsippany, United States, New Jersey, 07054 Job Id: 58170 Who 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,...
-
Hospital Nurse Director Case Management
3 months ago
Brockton, MA, United States Clinical Management Consultants Full timeA phenomenal Hospital Nurse Director Case Management career opportunity is now available in the southeast region of Massachusetts. Come join a renowned healthcare organization that is award-winning and focuses on providing collaborated, well-rounded healthcare experience to patients. The Nurse Director Case Management will work for a nonprofit hospital...
-
Director of Development
2 days ago
Boston, MA, United States Massachusetts Nonprofit Network Full timeRamah New England seeks a Director of Development who is a highly motivated, mission-driven, experienced, and strategic fundraiser and non-profit leader. Ambitious and entrepreneurial, the Director of Development will have the opportunity to elevate a culture of philanthropy, enhance the structure of the Development Department, and build a pipeline of the...
-
Clinical Director
2 days ago
, MA, United States Autism Care Partners Full timeFind your passion! ACP is looking for friendly faces, positive attitudes, and playful personalities to bring our services to life. We offer opportunities for individuals at all stages of their careers the opportunity to join a team of like-minded individuals who are passionate about changing the lives of the children and families we serve. Come grow with...
