clinical development manager

Regeneron

<div><p>We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).<br>
</p><p></p><p>As a Senior Manager, a typical day may include the following:<br>
</p><p><br>
- Supports the cross-functional study team on the following activities, including but not limited to:
</p><p>- Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
</p><p>- Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts
</p><p>- Represents the clinical ECD&amp;ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
</p><p>- Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
</p><p>- Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator&rsquo;s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
</p><p>- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
</p><p>- Trains and support study team and CRO personnel regarding clinical aspects of trial
</p><p>- Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
</p><p>- Organizes steering committees, advisory boards, and data safety monitoring boards as required
</p><p>- Identifies program, trial or data risks, creates and implements mitigation strategies
</p><p>- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
</p><p>- Provides background literature searches in support of:
</p><p>- Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
</p><p>- POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy<br>
</p><p></p><p>This role may be for you if:<br>
</p><p><br>
- Effective communications (verbal &amp; written) and presentation skills are essential
</p><p>- Must be able to work productively in a fast-paced collaborative environment
</p><p>- Demonstrated/potential for critical thinking skills and sound decision-making<br>
</p><p></p><p>To be considered for this role, you must have a Bachelor&rsquo;s degree. Ph.D., PharmD. or Master&rsquo;s degree in biomedical subject. Additionally, we are seeking 8 years of clinical research/development experience
</p><p></p><div><div><div><div><div><div><div><p>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries&rsquo; specific benefits, please speak to your recruiter.
<br>
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron&rsquo;s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron&rsquo;s on-site policy and expectations for your role and your location.<br>
<br>
</p><p></p><p>Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
</p><p></p><p>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
</p><p></p><p>Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
</p><p></p><p><b>Salary Range (annually)
</b></p></div></div></div></div></div></div></div>$150,500.00 - $245,500.00</div>

Senior Manager, Clinical Scientist, Genetics Medicine

Bristol Myers Squibb

<div><b>Working with Us</b><br>
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 production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
<br>
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
<br>
<b>The Clinical Development Program Leader (Executive Director) sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
</b><ul><li>The Clinical Development Program Leader will set the clinical development strategy for assets or indications
</li><li>The Clinical Development Program Leader will directly supervise the work of multiple Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians unless otherwise indicated
</li><li>This role will include above disease / indication strategy work (i.e. supervising Broad Clinical Development teams across several Development teams, as well as Disease / Indication Strategy teams etc.)
</li><li>The role will be foundational in working with teams in R &amp; ED and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments
</li><li>The role will supervise the development of differentiated and strategic Clinical Development Physicians (CDPs) for multiple transition assets and support a broad program of work from phase I expansion through to registrational execution
</li><li>The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership
</li><li>The role will report directly to the Head of Clinical Development and will deputize as required, and will be a core member of the Therapeutic Area clinical development executive leadership team
</li></ul><b>Key Responsibilities</b><br>
<br>
<b>Strategy and Execution</b><ul><li>
Create and communicate a vision for designing, conducting and executing innovative clinical development plans
</li><li>This leader will supervise the development, monitoring, analysis and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings
</li><li>Will contribute to overall strategy for specific disease / indications while ensuring a franchise overall portfolio view
</li><li>Provide strategic insights into the clinical development plans
</li><li>Lead search and evaluation activities on business development due diligence efforts, and advice to our strategic transactions group
</li><li>Key Member of Therapeutic Area Clinical Development Leadership Team and chairing forum as required
</li><li>Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis
</li><li>Will build a franchise reputation that attracts innovators to bring their ideas to BMS
</li></ul><b>Drug Development Experience</b><ul><li>
Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management</li></ul><b>
Leadership and Matrix Management</b><ul><li>
Lead and develop a group of Clinical Development professionals (team of up to 50 individuals both direct and indirect) whose therapeutic area focus is in a specific disease area / indication and will ensure scientific and technical excellence of clinical development programs and deliverables</li><li>
This individual will recruit, develop and retain strong talent</li><li>
Mentoring of talent/staff</li><li>
Will establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture</li><li>
Will be responsible for developing a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement</li><li>
Will be responsible for oversight of team budget and headcount</li></ul><b>
Stakeholder Engagement and Communication</b><ul><li>
Will work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field</li><li>
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)</li></ul><b>
Governance Participation and Signature Authority</b><ul><li>
Governance participation ad hoc as designated</li><li>
PRC Chair ad hoc as needed</li><li>
Signature Authority for:</li></ul><ul><li>
CSRs</li><li>
Health Authority Briefings</li><li>
DMC Charters</li><li>
Unblinding Requests</li><li>
Health Authority Documents for Filings</li><li>
And other clinical accountable documents delegated as needed</li></ul><b>
Qualifications &amp; Experience</b><ul><li>
MD (PhD or other high level degree optional)</li></ul><b>
Experience Requirements:</b><ul><li>
The ideal candidate will be a clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong scientific background</li><li>
Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience.</li><li>
The successful candidate will understand early-stage drug development, extensive experience designing and conducting Phase I, II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval</li><li>
Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies</li><li>
Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy</li></ul><b>
Key Competency Requirements:
</b><ul><li>Proven track record in managing complex clinical programs leading to regulatory submissions</li><li>
Deep understanding of Biology, targets and translational science</li><li>
Extensive experience of work with health authorities at all levels</li><li>
Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials</li><li>
Proven ability to execute the BMS R&amp;D People Strategy, and lead and develop a matrix team</li><li>
The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory</li><li>
The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment</li><li>
In addition, the candidate must be skilled at interacting externally, and at speaking engagements</li><li>
Must be skilled at attracting, developing, and retaining skilled professionals</li></ul><b>
Travel Required</b><ul><li>
Domestic and International travel may be required.</li></ul>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
<br>
<br>
<b>Compensation Overview:</b><br>
<br>
$340,870 - $413,051<br>
<br>
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
<br>
<br>
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
<br>
<br>
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
<br>
<br>
<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
<br>
<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
<br>
<br>
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
<br>
<br>
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
<br>
<br>
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.<br>
<br>
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
<br>
<br>
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</div>

Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Canyon Home Care and Hospice

<div><div><div>Location: Colorado and Arizona (Travel Required)</div></div><div><div>
Job Type: Full-Time</div></div><div><div>
Position Summary:</div></div><div><div>
The Regional Clinical Manager is responsible for providing clinical oversight, mentorship, and operational support to the Clinical Directors and nursing teams across all home health and hospice branches in Colorado and Arizona. This role ensures clinical excellence, regulatory compliance, and quality improvement initiatives across the state. The Regional Clinical Manager works collaboratively with the Home Office Clinical Team, Clinical Directors and branch leadership to drive best practices in patient care, staff training, and performance improvement.</div></div><div><div>
Key Responsibilities:</div></div><div><div>
Clinical Leadership &amp; Oversight:</div></div><ul><li><div>
Provide statewide clinical oversight for home health and hospice services, ensuring consistent quality of care across all locations.</div></li><li><div>
Partner with Clinical Directors to implement and maintain clinical best practices, policies, and procedures.</div></li><li><div>
Conduct onsite and virtual visits to support teams in managing complex patient cases, addressing compliance issues, and improving clinical outcomes.</div></li><li><div>
Lead quality assurance and performance improvement (QAPI) initiatives, ensuring high patient satisfaction and regulatory compliance.</div></li><li><div>
Oversee clinical documentation audits, providing coaching and feedback to improve accuracy, efficiency, and compliance.</div></li></ul><div><div>
Support &amp; Development of Clinical Directors:</div></div><ul><li><div>
Serve as a mentor and advisor to Clinical Directors, helping them navigate leadership challenges and improve their effectiveness.</div></li><li><div>
Assist in training and onboarding new Clinical Directors and nursing leaders to ensure consistency in clinical operations.</div></li><li><div>
Facilitate monthly Clinical Director meetings to review metrics, discuss challenges, and align goals across branches.</div></li><li><div>
Provide hands-on support for TPE (Targeted Probe and Educate) audits, state and federal surveys, and compliance-related initiatives.</div></li></ul><div><div>
Staff Training &amp; Development:</div></div><ul><li><div>
Conduct statewide education and training programs for clinical staff, covering topics such as regulatory updates, documentation best practices, and symptom management.</div></li><li><div>
Lead skills labs, in-services, and case study reviews to enhance nursing competency.</div></li><li><div>
Support retention efforts by fostering a strong clinical culture, engagement, and professional development opportunities.</div></li></ul><div><div>
Regulatory Compliance &amp; Quality Improvement:</div></div><ul><li><div>
Ensure all clinical practices adhere to Medicare, Medicaid, and accreditation requirements for home health and hospice.</div></li><li><div>
Assist in preparing for surveys and audits, developing action plans to address deficiencies.</div></li><li><div>
Track key clinical performance indicators (KPIs) such as rehospitalization rates, infection rates, and documentation compliance, implementing improvement plans as needed.</div></li><li><div>
Work closely with interdisciplinary teams, including administrators, physicians, and quality leaders, to enhance patient care.</div></li></ul><div><div>
Operational &amp; Strategic Support:</div></div><ul><li><div>
Provide temporary leadership support to branches with vacancies in Clinical Director roles.</div></li><li><div>
Assist with problem-solving and troubleshooting operational challenges that impact clinical efficiency and quality.</div></li><li><div>
Collaborate with senior leadership to develop strategic initiatives that improve clinical outcomes and streamline operations.</div></li><li><div>
Travel across Colorado and Arizona to support branches, with a mix of onsite visits between locations. There will also be occasional travel to Utah for Home Office training and support.
</div></li></ul><div><div>Qualifications:</div></div><ul><li><div>
Active Registered Nurse (RN) license in Colorado and Arizona.</div></li><li><div>
Minimum 5 years of home health and hospice experience in a leadership or quality role (Clinical Director, Quality Manager, or similar).</div></li><li><div>
Strong knowledge of Medicare, Medicaid, and accreditation standards for home health and hospice.</div></li><li><div>
Demonstrated experience in mentoring, training, and developing clinical leaders.</div></li><li><div>
Proficiency in electronic medical records (EMR) systems (experience with MatrixCare a plus).</div></li><li><div>
Excellent leadership, communication, and problem-solving skills.</div></li><li><div>
Ability to travel extensively across the state (valid driver&rsquo;s license and reliable transportation required).</div></li></ul></div>

Regional Clinical Manager-Colorado and Arizona

<div><div><div>Location: Statewide, Idaho (Travel Required)</div></div><div><div>
Job Type: Full-Time</div></div><div><div>
Position Summary:</div></div><div><div>
The Regional Clinical Manager is responsible for providing clinical oversight, mentorship, and operational support to the Clinical Directors and nursing teams across all home health and hospice branches in Idaho. This role ensures clinical excellence, regulatory compliance, and quality improvement initiatives across the state. The Regional Clinical Manager works collaboratively with the Home Office Clinical Team, Clinical Directors and branch leadership to drive best practices in patient care, staff training, and performance improvement.</div></div><div><div>
Key Responsibilities:</div></div><div><div>
Clinical Leadership &amp; Oversight:</div></div><ul><li><div>
Provide statewide clinical oversight for home health and hospice services, ensuring consistent quality of care across all locations.</div></li><li><div>
Partner with Clinical Directors to implement and maintain clinical best practices, policies, and procedures.</div></li><li><div>
Conduct onsite and virtual visits to support teams in managing complex patient cases, addressing compliance issues, and improving clinical outcomes.</div></li><li><div>
Lead quality assurance and performance improvement (QAPI) initiatives, ensuring high patient satisfaction and regulatory compliance.</div></li><li><div>
Oversee clinical documentation audits, providing coaching and feedback to improve accuracy, efficiency, and compliance.</div></li></ul><div><div>
Support &amp; Development of Clinical Directors:</div></div><ul><li><div>
Serve as a mentor and advisor to Clinical Directors, helping them navigate leadership challenges and improve their effectiveness.</div></li><li><div>
Assist in training and onboarding new Clinical Directors and nursing leaders to ensure consistency in clinical operations.</div></li><li><div>
Facilitate monthly Clinical Director meetings to review metrics, discuss challenges, and align goals across branches.</div></li><li><div>
Provide hands-on support for TPE (Targeted Probe and Educate) audits, state and federal surveys, and compliance-related initiatives.</div></li></ul><div><div>
Staff Training &amp; Development:</div></div><ul><li><div>
Conduct statewide education and training programs for clinical staff, covering topics such as regulatory updates, documentation best practices, and symptom management.</div></li><li><div>
Lead skills labs, in-services, and case study reviews to enhance nursing competency.</div></li><li><div>
Support retention efforts by fostering a strong clinical culture, engagement, and professional development opportunities.</div></li></ul><div><div>
Regulatory Compliance &amp; Quality Improvement:</div></div><ul><li><div>
Ensure all clinical practices adhere to Medicare, Medicaid, and accreditation requirements for home health and hospice.</div></li><li><div>
Assist in preparing for surveys and audits, developing action plans to address deficiencies.</div></li><li><div>
Track key clinical performance indicators (KPIs) such as rehospitalization rates, infection rates, and documentation compliance, implementing improvement plans as needed.</div></li><li><div>
Work closely with interdisciplinary teams, including administrators, physicians, and quality leaders, to enhance patient care.</div></li></ul><div><div>
Operational &amp; Strategic Support:</div></div><ul><li><div>
Provide temporary leadership support to branches with vacancies in Clinical Director roles.</div></li><li><div>
Assist with problem-solving and troubleshooting operational challenges that impact clinical efficiency and quality.</div></li><li><div>
Collaborate with senior leadership to develop strategic initiatives that improve clinical outcomes and streamline operations.</div></li><li><div>
Travel across Idaho to support branches, with a mix of onsite visits between locations. There will also be occasional travel to Utah for Home Office training and support.
</div></li></ul><div><div>Qualifications:</div></div><ul><li><div>
Active Registered Nurse (RN) license in Idaho.</div></li><li><div>
Minimum 5 years of home health and hospice experience in a leadership or quality role (Clinical Director, Quality Manager, or similar).</div></li><li><div>
Strong knowledge of Medicare, Medicaid, and accreditation standards for home health and hospice.</div></li><li><div>
Demonstrated experience in mentoring, training, and developing clinical leaders.</div></li><li><div>
Proficiency in electronic medical records (EMR) systems (experience with MatrixCare a plus).</div></li><li><div>
Excellent leadership, communication, and problem-solving skills.</div></li><li><div>
Ability to travel extensively across the state (valid driver&rsquo;s license and reliable transportation required).</div></li></ul></div>

Regional Clinical Manager-Idaho

Search 10000+ Clinical development manager jobs near you this November. New roles added regularly across leading industries. Apply today.

10000 clinical development manager jobs NEAR_ME

Senior Manager, Clinical Scientist, Genetics Medicine

Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Regional Clinical Manager-Colorado and Arizona

Regional Clinical Manager-Idaho