-
Takeda Pharmaceuticals Raleigh, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Physical Therapist
1 week ago
HealthPRO Heritage Raleigh, United StatesOverview · HealthPRO Pediatrics has full time openings for School Physical Therapists for the 24/25 School Year · Join our Pediatric School Based Team, and use your passion for Physical Therapy to help make a difference in a child's life · School Physical Therapist position avai ...
-
Physical Therapist
1 week ago
HealthPRO Heritage Raleigh, United StatesOverview · HealthPRO Pediatrics has full time openings for School Physical Therapists for the 24/25 School Year · Join our Pediatric School Based Team, and use your passion for Speech Therapy to help make a difference in a child's life · School Physical Therapist position availa ...
-
Duke Health Raleigh, United States Full timeThe Department of Neurology at Duke University School of Medicine seeks board eligible/board certified subspecialty Neurologists to join its expanding outpatient neurology practice in the rapidly growing Raleigh-Durham, NC area. Subspecialty trained Neurologists in Headache, Neur ...
-
Developmental and Behavioral Physician
3 days ago
Mission Health Asheville, United StatesDescription · Specialization: · Pediatric Developmental and Behavioral · Job Summary: · Mission Children's Olson Huff Center is seeking a pediatrician to join our developmental behavioral pediatrics team in Asheville, NC. · Qualified Candidates:Fellowship training and board-cert ...
-
Duke Health Raleigh, United States Full timeDuke Orthopaedic Surgery and Duke Pediatrics are seeking an additional Pediatric Rehabilitation Physiatrist to join an established Pediatrics Rehabilitation Medicine (PRM) Service in Raleigh-Durham, NC. Candidates must be board eligible or certified in Physical Medicine & Rehabil ...
-
Peds Neuro Muscular Program Triage Nurse
1 day ago
Duke Health Raleigh, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke University Hospital · Pursue ...
-
Physical Therapist
1 week ago
HealthPRO Heritage Raleigh, United States Regular Full timeOverview · HealthPRO Pediatrics has full time openings for School Physical Therapists for the 24/25 School Year · Join our Pediatric School Based Team, and use your passion for Speech Therapy to help make a difference in a child's life · School Physical Therapist position avai ...
-
Associate Director, Bioassay Development
1 week ago
AskBio Asklepios BioPharmaceutical, Inc. Raleigh, United StatesAssociate Director, Bioassay Development page is loaded · Associate Director, Bioassay Development · Apply · locations · Durham, NC · time type · Full time · posted on · Posted 6 Days Ago · job requisition id · R24-36 · Asklepios BioPharmaceutical, Inc. (AskBio) is a l ...
-
VP, GDNF Clinical Development
6 days ago
AskBio Asklepios BioPharmaceutical, Inc. Raleigh, United StatesVP, GDNF Clinical Development page is loaded · VP, GDNF Clinical Development · Apply · locations · Remote US · time type · Full time · posted on · Posted 6 Days Ago · job requisition id · R24-31 · Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage ...
-
Associate Director, Regulatory Operations
6 days ago
Asklepios Biopharmaceutical Raleigh, United StatesAssociate Director, Regulatory Operations page is loaded · Associate Director, Regulatory Operations · Apply · locations · US Remote NC · US Remote PA · time type · Full time · posted on · Posted 18 Days Ago · job requisition id · R24-69 · Asklepios BioPharmaceutical, ...
-
Associate Director, Regulatory Operations
6 days ago
AskBio Asklepios BioPharmaceutical, Inc. Raleigh, United StatesAssociate Director, Regulatory Operations page is loaded · Associate Director, Regulatory Operations · Apply · locations · US Remote NC · US Remote PA · time type · Full time · posted on · Posted 20 Days Ago · job requisition id · R24-69 · Asklepios BioPharmaceutical, ...
-
Clinical Area Manager
6 days ago
Electromed Raleigh, United StatesJob Description · Job Description · People Purpose: · Beyond Competitive · It is no longer ok to just be competitive regarding how we treat our people in everything we do. Our leadership team believes wholeheartedly we need to be beyond competitive and cultivate a culture of p ...
-
Clinical Area Manager
4 days ago
Electromed Inc. Raleigh, United StatesJob Description · Job DescriptionPeople Purpose: Beyond Competitive · It is no longer ok to just be competitive regarding how we treat our people in everything we do. Our leadership team believes wholeheartedly we need to be beyond competitive and cultivate a culture of proud, dr ...
-
Patient Services Coordinator
1 week ago
CORA Physical Therapy Raleigh, United StatesPatient Services Coordinator - Float · Ignite Your Career With CORA · As a Patient Services Coordinator at CORA, you'll be a vital part of our clinic support team by providing meaningful patient interactionsand exceptional customer service. You'll perform a wide range of admini ...
-
Duke Health Durham, United States Full timeThe Department of Neurology at Duke University School of Medicine seeks board eligible/board certified Neurologist with Neuromuscular fellowship training to join its expanding outpatient neurology practice in the rapidly growing Raleigh-Durham, NC area. Hired physician will see p ...
-
Nursing Assistant I + Clerical
1 week ago
UNC Health Care Chapel Hill, United StatesJob Description · Description · *This position qualifies for our Nursing Support Incentive Program. The Nursing Support Incentive Program includes $5,000 paid over a three (3) year commitment. Learn more about the program here: · Nursing Assistant I + Clerical (Clinical Support ...
-
Clinical Support Tech I
4 days ago
UNC Health Care Chapel Hill, United StatesJob Description · Description · Nursing Assistant I + Clerical (Clinical Support Tech I - Per Diem) needed for Neurosurgery / Neurology Acute Care Unit - 6 Neuroscience. This is a 32-bed unit that serves Neurosurgery and Neurology patients which includes a 7 bed Epilepsy Monitori ...
-
Clinical Assistant Professor
6 days ago
University of North Carolina at Chapel Hill Chapel Hill, United StatesA global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the art ...
-
peds neuro muscular program triage nurse
6 days ago
Duke University Durham, NC , USA, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke University Hospital · Pursue ...
VP, Clinical Development, Neuromuscular - Raleigh, United States - AskBio Asklepios BioPharmaceutical, Inc.
Description
VP, Clinical Development, Neuromuscular page is loadedVP, Clinical Development, Neuromuscular
Apply
locations
Remote US
time type
Full time
posted on
Posted Yesterday
job requisition id
R24-37
Asklepios BioPharmaceutical, Inc.
(AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD.
Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.At AskBio, we've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology.
Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure.
Our gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform.
Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.Our vision:
Pioneering science to create transformative molecular medicines.
Our mission:
Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
Advance innovative science by pushing boundaries.
Bring transformative therapeutics to patients in need.
Provide an environment for employees to reach their fullest
potential.
Our values:
Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
Embrace Responsibility. We are humbled by the enormity of our
mission. We
hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
The Role
The Vice President (VP), Neuromuscular Clinical Development,
reporting to the Head Clinical Development with a dotted line to the Integrated Product Team (IPT) Leader for AskBio's Neuromuscular programs,
will be responsible for developing and implementing the IPT's clinical development strategy for clinical programs spanning all stages of product development.
a core member of the global Clinical Development organization and Neuromuscular IPT, the
VP for Neuromuscular Clinical Development
will work with all members of the IPT including Scientific Chair, IPT Leader, Program Manager, and functional leads for Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC.
The incumbent will be responsible for establishing and overseeing global clinical development strategies in alignment with the company's mission and values that will support regulatory approval and commercial launches in multiple territories including the US, EU and UK.
He or she will build and manage a team of medical directors andprovide leadership as co-chair of the IPT's Clinical Sub-team in collaboration with their co-chair VP, Neuromuscular Clinical Operations. The Clinical Sub-team
provides oversight of clinical research activities, including development of core documents such as clinical development plans, investigator brochures, clinical trial protocols, statistical analysis plans, clinical study reports, and regulatory filings to meet program timelines.
As a senior leader of the Clinical Development organization, the VP for Neuromuscular Clinical Development is expected to provide insights and expertise to other IPTs and serve as a core member of the Protocol Review Committee at AskBio.
The VP, Neuromuscular Clinical Development will partner with AskBio's Safety and Pharmacovigilance teams to oversee medical monitoring and drug safety reporting, and will work closely with the Clinical Operations, Regulatory, Medical Affairs and Patient Advocacy teams on clinical study planning and resource management to execute global clinical studies.
Furthermore, he or she will be positioned to expand and support the company's global relationships with clinical sites, investigators, patient and community organizations, internal functional teams, and third-party vendors.
Responsibilities & AccountabilitiesProvide strategic clinical development leadership to AskBio's Neuromuscular IPT, working to secure cross-functional alignment via active and transparent discussions.
Recruit, lead, and mentor a team of development physicians and clinical scientists.
Partner with the IPT to source clinical, biostatistics and KOL support.
Contribute to development and execution of the clinical strategy, ensuring that the overall scientific and medical content of each clinical study is scientifically rigorous, cost-effective sound and designed for success.
Provide input to CDP development, in line with the Target Product Profile (TPP), for successful global regulatory approvals and market access.
Partner with IPT colleagues (including Clinical Operations, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC) and other functional leaders to design, execute and report clinical trials.
Partner with Clinical Operations to co-chair the Clinical IPT Subteam to provide medical oversight of study design and execution, assure timely initiation of studies, support recruitment and retention activities, and achieve program milestones on time and within budget.
Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Trial Protocols (CTPs), Investigator's Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs.
Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
Lead the Neuromuscular Clinical Development team during interactions regarding drug development, safety, marketing, regulatory filing, and other aspects of a Neuromuscular gene therapy product life cycle
As the medical expert, participate in interactions with external stakeholders (e.g., regulatory authorities, KOLs, Data Monitoring Committee (DMC), advisory boards, patient advocacy groups)
Work collaboratively to prepare and present abstracts, manuscripts and presentations for external meetings and publications.
May support technical due diligence in Business Development & Licensing (BD&L) activities.
About you
MD, DO or equivalent (based on the current World Directory of Medical Schools) is required; specialty training, patient care, and/or extensive drug development experience in neuromuscular diseases strongly preferred
At least 10 years of clinical development experience in an industry environment spanning clinical activities in Phases I through III/IV is required
Strong track record and demonstrated excellence in IND/NDA/BLA submissions and approvals
Advanced clinical training/knowledge or clinical research experience in a medical/scientific area, preferably aligned with AskBio's focused therapeutic areas (cardiovascular, CNS, neuromuscular, metabolic, and genetic disorders) is preferred
In-depth knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development process
Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders
Demonstrated strong leadership and effective communication skills with a documented record of delivering high quality
projects/submissions/trials
in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO is required
Firsthand experience in organizing and managing scientific or clinical advisory boards
Advanced knowledge in gene therapy, training or experience in neurosciences with the capability to innovate in clinical development study designs that provide robust clinical evidence to internal decision-makers and regulatory agencies is preferred
Experience in hiring, mentoring, and retaining clinical development/medical directors or scientists is a strong plus
Asklepios BioPharmaceutical, Inc.
(AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws.
All employment decisions are based on valid job‐related requirements.If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at or sending us an email at .
Agencies:
Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio
unless
the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement.
If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
Similar Jobs (2)VP, GDNF Clinical Development
locations
2 Locations
time type
Full time
posted on
Posted 6 Days Ago
Clinical Trial Manager - CNS
locations
Remote US
time type
Full time
posted on
Posted 30+ Days Ago
Asklepios BioPharmaceutical, Inc.
(AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD.
Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.At AskBio, we've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology.
Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure.
Our gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform.
Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.#J-18808-Ljbffr
VP, Clinical Development, Neuromuscular professionals in Raleigh
-
Nick Dudas (ndudas)
Analyst/Project Management
-
Stephanie Ladd
Senior Clinical Research Professional