-
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 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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
Vice President, Clinical Development
3 weeks ago
Xilio Therapeutics Waltham, United StatesVice 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 ...
-
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 ...
-
Kisbee Therapeutics Cambridge, United StatesCOMPANY OVERVIEW · Kisbee Therapeutics is an early-stage, venture-backed biotech startup that is targeting apolipoproteins to develop novel therapeutic agents for neurodegenerative diseases. Our mission is to translate genetic and biochemical insights into therapies that promote ...
-
Vice President, Clinical Development
4 days ago
LifeMine Therapeutics Cambridge, United StatesLifeMine is seeking a physician to work in partnership with CMO and co-lead the development of LifeMine's clinical strategy. The successful candidate will have experience in the design and authorship of clinical trial protocols including first-in-human clinical trials, selection, ...
-
Vice President, Clinical Development
3 weeks ago
Editas Medicine, Inc. Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
Vice President, Clinical Development
4 weeks ago
Editas Medicine Cambridge, United StatesJob Description · Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harne ...
-
Director, Early Clinical Development
3 days ago
Bristol-Myers Squibb Cambridge, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't 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 productio ...
-
Associate Director Clinical Development
3 weeks ago
Philips Cambridge, United StatesPhilips · Associate Director Clinical Development · Cambridge , · Massachusetts · Apply Now · 501628 Associate Director Clinical Development · Join us in advancing care to saving and improving lives around the world for the cardiac Implantable electronic device management an ...
Vice President, Clinical Development - Watertown, United States - Alkermes
Description
Job 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 responsibilities in the clinical department involved in the development of therapies for Neurology indications, including neurogenerative and sleep disorders.
The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports.The Vice President will interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders.
This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical pharmacology and toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs and commercial.
ResponsibilitiesPrimary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across Neurology.Direct authorship contributions in protocols, clinical study reports, and publications.
Lead and develop clinical development staff and oversee hiring of additional staff as needed.
Interact with senior management and serve as a standing member of multiple leadership meetings.
Serve as a primary internal and external spokesperson for Alkermes Neurology clinical development programs.
Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
Generate yearly strategic goals and objectives for the group.
In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met.
In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required.
Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
Identify and develop collaborative relationships with key investigators, and key thought leaders globally. Attend and oversee clinical advisory boards and investigator meetings.Critically review and contribute to regulatory interactions (such as INDs and NDAs).Experience in overseeing the professional development and management of the clinical sciences team.
QualificationsRequires a MD with a Neurology background and Board Certification, alongside significant clinical and academic expertise in the field of Neurology.
Accomplished, experienced, pharmaceutical professional with 10+ years of experience in the industry.A business-focused individual, with experience in all aspects of drug development, including in-licensing.
A person who has built on their medical expertise and successfully applied this to enhance the development and commercialization of NCEs.
Key strengths include focus on outcomes, ability to work in complex matrix structures, strong scientific insights, and strong communication skills with both internal and external audiences.
Displays strong leadership and collaborative interpersonal skills.Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
Able to work independently, prioritize tasks efficiently and meet expected time frames.
Able to perform thorough reviews of various medical and legal documents in a timely manner. Excellent writing and presentation skills.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home.
This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week.
This role is not eligible for fully remote work.#LI-MB1About UsAlkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.
The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders.
Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
For more information, please visit Alkermes' website at , Inc.is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Alkermes is an E-Verify employer.