Medical Director, Clinical Development – Dermatology Job at Apogee Therapeutics

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

Director, Clinical Development – Dermatology/Immunology

We are seeking an experienced biotech industry Clinical Scientist for a Director...

Location

United States

Salary:

230000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in life science field (e.g., PhD, PharmD, or DVM)
Must have 5+ years of experience in research
2+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry preferred
Focus on dermatology, particularly experience in atopic dermatitis desired
Strong understanding of clinical trial design, execution, and data analysis
Analytical mindset and ability to interpret complex scientific data
Ability to manage multiple competing priorities with good planning, time management and prioritization skills
Strong communication, technical writing, and presentation skills
Proven ability to work in a cross-functional team environment
Solid knowledge of Good Clinical Practice (GCP) and ethical guidelines governing clinical research

Job Responsibility

Collaborate with cross-functional teams to develop clinical documents for dermatology-related trials
Contribute scientific input and implementation into the study design and execution
Monitor the clinical trials for both quality and safety
Analyze clinical trial data, interpret results, and provide scientific insights
Collaborate with data management and biostatistics to develop and validate data collection tools
Foster relationships with clinical investigators
Stay current with scientific literature and advancements in dermatology/immunology
Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams

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

R&D Director

Flen Health is looking for a dynamic and visionary R&D Director who combines str...

Location

Belgium , Kontich

Salary:

Not provided

Flen Health GmbH

Expiration Date

Until further notice

Requirements

Ph.D. in biopharmaceutical sciences, molecular biology, or a related discipline
Extensive experience in biopharmaceutical R&D, with a strong track record in wound healing and dermatology
Demonstrated hands-on expertise in functional genomics, structural and molecular biology, computational methods, and advanced skin and wound modelling
Proven success in leading and actively participating in teams and complex research projects
Strong publication and patent record in peer-reviewed journals, with direct contributions to scientific literature
Experience in securing and managing national and international research grants, including hands-on grant writing and project execution
Proven ability to lead international research consortia, delivering impactful outcomes through both strategic oversight and direct scientific involvement
Background in topical product development, with practical experience in formulation and testing

Job Responsibility

Provide both strategic direction and active, hands-on leadership to the R&D team, personally engaging in critical research activities and mentoring scientists at all levels
Lead by example in the discovery and development of new biopharmaceutical compounds, directly contributing expertise to projects targeting wound healing and skin inflammation
Build and strengthen the scientific evidence base for existing medical device products through direct involvement in experimental design, data analysis, and publication
Integrate disease insights with advanced pre-clinical methodologies, including functional genomics, structural and molecular biology, computational approaches, and both in vitro and in silico skin and wound models- by actively participating in experimental work and troubleshooting
Foster a culture of collaboration, innovation, and continuous improvement within the team by working side-by-side with team members and encouraging open scientific dialogue
Maintain a relentless focus on delivering value to patients and healthcare professionals ensuring that leadership decisions are grounded in practical, real-world impact
Establish and expand national and international research networks, leading projects and consortia that result in commercially viable innovative patents and products, including those supported by scientific grant programs

What we offer

Excellent working conditions
An innovative and inspiring work environment
Independent project work & responsibilities within a professional team
Career prospect
Learning and development opportunities
Flexible working ecosystem
Enthusiastic colleagues
Attractive remuneration package

Fulltime

Associate Director, Monitoring Oversight Management

We are seeking an Associator Director, Monitoring Oversight Management, to manag...

Location

United States

Salary:

180000.00 - 205000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
Minimum 5 years of experience leading a team of CRAs
Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
Experience working in Phase I – III clinical trials
Recent experience working on trials utilizing risk-based monitoring models
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct

Job Responsibility

Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials
Support contract Oversight CRAs globally
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs
Contribute to building a culture of team, site and patient centricity
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies
Leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality
Responsible for hiring in-house Oversight CRAs
Assist with creation, review and revision of departmental SOPs and policies
Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs
Assist with creation and delivery of department initiatives, improvement plans and/or training

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

R&D Director

We are looking for a dynamic and visionary R&D Director who combines strategic l...

Location

Belgium , Kontich

Salary:

Not provided

Flen Health GmbH

Expiration Date

Until further notice

Requirements

Ph.D. in biopharmaceutical sciences, molecular biology, or a related discipline
Extensive experience in biopharmaceutical R&D, with a strong track record in wound healing and dermatology
Demonstrated hands-on expertise in functional genomics, structural and molecular biology, computational methods, and advanced skin and wound modelling
Proven success in leading and actively participating in teams and complex research projects
Strong publication and patent record in peer-reviewed journals, with direct contributions to scientific literature
Experience in securing and managing national and international research grants, including hands-on grant writing and project execution
Proven ability to lead international research consortia, delivering impactful outcomes through both strategic oversight and direct scientific involvement
Background in topical product development, with practical experience in formulation and testing

Job Responsibility

Provide both strategic direction and active, hands-on leadership to the R&D team, personally engaging in critical research activities and mentoring scientists at all levels
Lead by example in the discovery and development of new biopharmaceutical compounds, directly contributing expertise to projects targeting wound healing and skin inflammation
Build and strengthen the scientific evidence base for existing medical device products through direct involvement in experimental design, data analysis, and publication
Integrate disease insights with advanced pre-clinical methodologies, including functional genomics, structural and molecular biology, computational approaches, and both in vitro and in silico skin and wound models- by actively participating in experimental work and troubleshooting
Foster a culture of collaboration, innovation, and continuous improvement within the team by working side-by-side with team members and encouraging open scientific dialogue
Maintain a relentless focus on delivering value to patients and healthcare professionals ensuring that leadership decisions are grounded in practical, real-world impact
Establish and expand national and international research networks, leading projects and consortia that result in commercially viable innovative patents and products, including those supported by scientific grant programs

What we offer

Excellent working conditions
An innovative and inspiring work environment
Independent project work & responsibilities within a professional team
Career prospect
Learning and development opportunities
Flexible working ecosystem
Enthusiastic colleagues
Attractive remuneration package

Fulltime

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Stimulating CPD sessions and programs including mentoring, medical leadership, and coaching
Teaching opportunities in our brand-new state of the art Medical Education Centre
Employee Excellence awards
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GCSE in Maths and English or equivalent
A desire to make a difference and progress in your career

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Free On-site parking
Free use of school facilities including onsite gym
Career progression opportunities
Term time only
Fully funded training and qualifications
Welcoming staff room with a ready supply of tea and biscuits

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Medical Director, Clinical Development – Dermatology

Job Description

Job Responsibility

Requirements

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