- Accountable for the strategic vision to brings new treatment options to patients, including clinical development plans
- Work with Regulatory colleagues to develop registrational plans for emerging assets
- Accountable for clinical development plans and, in partnership with Clinical Operations, data generation through the execution of clinical protocols
- In partnership with Medical Affairs, accountable for external scientific communication, including scientific publication and presentations
- Over time build, manage and mentor a team of physicians and clinical scientists
- Serve as the clinical leader on joint steering committees that are responsible for external partnerships and drive to desired outcomes
- Provide clinical and translational advice to our early project teams as they assess novel targets and consider potential clinical indications and paths forward
- Motivates and leads a group of physician and non-physician scientists (contractors, CRO teams, and as company grows, internal positions)
- Represent Xilio at key national and international medical and scientific meetings including participation and/or leadership of advisory boards in collaboration with medical affairs
- Maintain and expand Xilio's network of external clinical collaborators and advisors, both in the academic and community settings
- Oversees and participates in public presentations and publications of the company's clinical data for each program
- Accountable for administrative functions and budgets
- 15% travel, predominantly domestic
- Board certified M.D. or M.D./Ph.
- Strong leadership skills and demonstrated biopharmaceutical industry experience developing, planning, designing, and executing early and late-stage programs, creating submissions for health authority approvals, and taking products from development through commercialization
- Experience and comfort with highly complex and dynamic clinical trial designs.
- Strong working knowledge of the application of biostatistical principles to clinical trial design
- 5+ years of demonstrated ability in the biotechnology or pharmaceutical industry including direct experience leading and a detailed understanding of the drug development process from IND through NDA and the post-marketing setting
- Experience presenting to a wide variety of audiences including internal teams, patient advocacy groups, medical/scientific communities, and investors
- Strong working knowledge of the FDA and EMA
-
VP and Head of Clinical Development
5 days ago
Ensem Therapeutics Waltham, United StatesABOUT ENSEM THERAPEUTICS: · ENSEM Therapeutics ("ENSEM") is a Boston-based biopharmaceutical company focused on high value and difficult-to-drug targets in oncology to address unmet medical needs. The name ENSEM symbolizes innovations via the integration of groundbreaking Kinetic ...
-
Early Clinical Development, Medical Director
1 week ago
AstraZeneca Waltham, United States Full timeAt AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity, no matter how small, can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments ...
-
Vice President, Clinical Development
3 weeks ago
Alkermes Waltham, United StatesThis is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes's clinical development portfolio in Neurology. · Specifically, this position will have critical hands-on leadership responsibilities in the c ...
-
SVP, Head of Clinical Development
3 weeks ago
BioSpace Waltham, United StatesJob Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern olig ...
-
SVP, Head of Clinical Development
3 days ago
Dyne Therapeutics, Inc. Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide thera ...
-
Executive Director, Clinical Development
3 weeks ago
Alkermes Waltham, United StatesPosition Overview · This is a high impact position with great visibility across all levels of the Alkermes organization. · This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indic ...
-
Executive Director, Clinical Development
6 days ago
Alkermes Watertown, United StatesJob Description · Position Overview · This is a high impact position with great visibility across all levels of the Alkermes organization. · This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapie ...
-
Vice President, Clinical Development
2 weeks ago
Alkermes Watertown, United StatesJob DescriptionThis is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes's clinical development portfolio in Neurology. Specifically, this position will have critical hands-on leadership responsibili ...
-
Executive Director/VP, Clinical Development
2 weeks ago
Zenas BioPharma Waltham, United StatesZenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global ...
-
CURE Waltham, United StatesSenior 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 contr ...
-
Senior Medical Director, Clinical Development
6 hours ago
DynamiCure Biotechnology Waltham, United StatesSenior 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 design ...
-
Director, Clinical Development
5 days ago
Sarepta Therapeutics, Inc. Cambridge, United States Full timeThe Director, Clinical Development is responsible for leading a clinical sciences team responsible for advancement of Sarepta's clinical-stage programs. The individual is responsible for defining strategic priorities for the program and integrating cross-functional input in order ...
-
VP/Exec/Sr/Director Clinical Development
3 weeks ago
Stratacuity Waltham, United StatesSenior Medical Director/Executive Medical Director/VP of Clinical Development Location: Waltham, MA (Hybrid) Therapeutic Area: Immuno-Oncology Job Overview: This role is for a knowledgeable and experienced individual to support clinical stage activities, responsible for developin ...
-
Invivyd Inc. Waltham, United StatesABOUT US · Invivyd is on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. · The company's proprietary INVYMAB platform approach combines ...
-
Director Clinical Development Scientist
3 weeks ago
Aura Biosciences Inc. Brighton, United StatesAbout Aura: · Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immun ...
-
Director Clinical Development Scientist
4 weeks ago
Aura Biosciences Brighton, United StatesJob Description · Job DescriptionSalary: · About Aura: · Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune sy ...
-
Clinical Development Lead
1 week ago
Bristol-Myers Squibb Cambridge, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Vice President, Clinical Development
3 weeks ago
SalioGen Therapeutics Lexington, United StatesAbout Us: · At SalioGen, we are leveraging the intrinsic genome engineering features of human evolution to harness the power of genetic medicine. Our approach, which we call "Gene Coding", is guided by our Exact DNA Integration Technology (EDIT): a genome engineering platform usi ...
-
Clinical Development Director
6 days ago
Korro Bio, Inc. Cambridge, United StatesKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...
-
Vice President, Clinical Development
3 weeks ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small mole ...
Vice President, Clinical Development - Waltham, United States - Xilio Therapeutics
Description
Vice President, Clinical Development
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments.
The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize their therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines and antibodies (including bispecifics) and immune cell engagers (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers).
Learn more by visiting and follow us on LinkedIn (Xilio Therapeutics, Inc.)SUMMARY:
The Vice President Clinical Development leads and sets the strategic direction for a group of medical team leaders in Clinical Development.
This position is closely partnered with SVP, Clinical Operations to strategically design and execute clinical studies aiming to deliver new treatment options to patients, and works closely with all functions across discovery research, non-clinical development, manufacturing, clinical pharmacology, translational science pharmacovigilance, regulatory, medical affairs and commercial.
Additionally, the Vice President Clinical Development interacts closely with the Xilio Executive Team. The Vice President will over time build and manage a team of physicians and scientists in Clinical Development organization. This role reports directly to the CMO.Responsibilities:
Required Qualifications:
At Xilio Therapeutics, we foster a culture of equity, diversity and inclusion.
We consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.
We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to#LI-NM1
