Director, Clinical Affairs Job at Baxter (Skaneateles Falls)

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum: BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Director, Medical Affairs - Clinical Nutrition, Pharmacy Tools and IV Fluids

As the Senior Director Medical Affairs, Clinical Nutrition, Pharmacy Tools and I...

Location

United States , Deerfield

Salary:

252000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree, such as PharmD or PhD required
MD, DO, PA or other clinical specialty considered
Minimum of 10+ years of industry experience, with at least some experience in nutrition ideal
Ability to travel 20-25%, including internationally

Job Responsibility

Leading and guiding a Global Medical Affairs team
Accountable for medical affairs work required to support Clinical Nutrition, IV Fluids and Pharmacy Solutions
Responsible for representing the company with regulatory and legislative agencies
Provide expert opinion/due diligence support on business development opportunities
Develop and manage budgets within scope of responsibility
Provide leadership for and partner with HEOR/RWE for clinical evidence generation strategy
Support Global Patient Safety as a product and subject matter expert

What we offer

Medical and dental coverage
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Senior Director, Medical Affairs - Clinical Nutrition, Pharmacy Tools and IV Fluids

As the Senior Director Medical Affairs, Clinical Nutrition, Pharmacy Tools and I...

Location

United States , Deerfield

Salary:

252000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree, such as PharmD or PhD required
MD, DO, PA or other clinical specialty considered
Minimum of 10+ years of industry experience, with at least some experience in nutrition ideal
Ability to travel 20-25%, including internationally
Experience in medical affairs, evidence generation, KOL management, Investigator Initiated Research (IIR) study management, new product development, business development and understanding due diligence
Proven people management/leadership skills
Strong executive presence with excellent leadership, managerial and interpersonal skills
Highly developed business acumen and ability to deal well with ambiguity
Ability to communicate complex scientific/clinical issues in a concise and clear manner
Broad understanding of the regulatory and healthcare environment

Job Responsibility

Leading and guiding a Global Medical Affairs team
Accountable for medical affairs work required to support Clinical Nutrition, IV Fluids and Pharmacy Solutions
Responsible for representing the company with regulatory and legislative agencies
Provide expert opinion/due diligence support on business development opportunities
Develop and manage budgets within scope of responsibility
Provide leadership for and partner with HEOR/RWE for clinical evidence generation strategy
Support Global Patient Safety as a product and subject matter expert

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Director, Clinical and Safety Quality

The Clinical & Safety Quality Director is responsible for establishing, leading,...

Location

United Kingdom , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 10–12 years of experience in pharmaceutical or biotech environments
At least 5 years in Clinical Quality Assurance and/or Pharmacovigilance Quality roles
Direct experience supporting Phase II–IV clinical development programs
Hands-on experience with regulatory inspections and health authority interactions
Experience in global or multi regional clinical development organizations is strongly preferred
Strong expertise in ICH-GCP and GVP requirements applicable to Sponsors
Demonstrated experience in clinical and/or pharmacovigilance quality oversight in a pharmaceutical company environment
Solid knowledge of outsourced clinical development models and CRO/vendor oversight
Proven ability to lead inspections, audits, and complex quality issue resolution
Strategic mindset with the ability to balance compliance, risk management, and operational agility

Job Responsibility

Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations)
Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners
Lead the development, maintenance, and continuous improvement of Clinical and PV Quality Management Systems, including SOPs, standards, and governance processes
Plan and execute quality oversight activities, including: Clinical and PV audits (internal, vendor, affiliates, system, and study audits), Quality risk assessments, Vendor qualification and performance monitoring
Ensure inspection readiness and act as quality lead during regulatory inspections (EMA, FDA, MHRA, PMDA) related to clinical and safety activities
Oversee CAPA management, deviation handling, and root cause analysis related to clinical and safety quality issues
Provide quality input and decision support to clinical development teams, pharmacovigilance, regulatory affairs, and senior management
Promote a quality culture across clinical and safety organizations, supporting training, coaching, and awareness initiatives
Monitor regulatory intelligence and proactively adapt quality processes to evolving requirements (e.g. EU CTR, ICH E6(R3), digital trials)
Contribute to portfolio and program governance committees as quality subject matter expert

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Medical Director, Clinical Policy

The Medical Director, Clinical Policy provides clinical leadership and strategic...

Location

United States , Los Angeles

Salary:

206311.00 - 350729.00 USD / Year

L.A. Care Health Plan

Expiration Date

Until further notice

Requirements

Doctor of Medicine (M.D.)
At least 8 years of experience in managed care, clinical policy development, or utilization management leadership
Extensive post-medical degree experience in clinical practice
Significant experience in a clinical development, medical affairs, or management role within the biotech, pharmaceutical, or healthcare industry
Proven experience in a physician leadership role, including managing teams
Board Certified, preferably in a primary or medical specialty - Active, current and unrestricted California license
Current clinical license to practice or an administrative license to review Utilization Management (UM) cases

Job Responsibility

Provide executive clinical leadership in the development, review, approval, and ongoing oversight of clinical policies and coverage criteria
Ensure all clinical policies comply with applicable federal, state, and accreditation requirements
Monitor emerging medical technologies, procedures, evidence-based practices, and external benchmarks
Provide strategic oversight of benefit design and clinical architecture
Validate codes, rules, and clinical logic are appropriately aligned and consistently applied
Oversee authorization matrix strategy and governance
Provide clinical direction for prior authorization requirements
Oversee the Clinical Criteria Hierarchy
Guide the strategic development of pre-payment review approaches
Oversee service-level utilization tracking and analysis

What we offer

Paid Time Off (PTO)
Tuition Reimbursement
Retirement Plans
Medical, Dental and Vision
Wellness Program
Volunteer Time Off (VTO)

Fulltime

Medical Director, Clinical Development - Dermatology/Immunology

We are seeking a Medical Director to oversee clinical execution and medical moni...

Location

United States

Salary:

280000.00 - 325000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ industry experience as a medical monitor and/or medical director
Experience working on phase 2 and 3 clinical studies required
Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability to travel approximately 20% to All Team meetings, functional meetings, study-related activities, and medical conferences

Job Responsibility

Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
Support the design of trials and develop protocols and other relevant documents for individual studies
Support all the start-up activities related to the assigned dermatology clinical study
Oversee day-to-day clinical and medical execution of studies
Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
Partner with clinical operations on site selection, recruitment, and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

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