Associate Director, Project Management Clinical Development på Phadia AB i
Phadia AB · Sweden
Associate Director, Project Management Clinical Development
Thermo Fisher Scientific is looking for an experienced clinical project management leader to oversee complex, international clinical research projects.
You may ...
Thermo Fisher Scientific is looking for an experienced clinical project management leader to oversee complex, international clinical research projects.
You may work as a Project Lead, provide strategic project oversight, manage and develop colleagues, or combine elements of these responsibilities according to business needs. You will be accountable for delivering projects to agreed standards of quality, time and cost while maintaining strong relationships with customers and cross-functional teams.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. In this role, your leadership will help customers progress promising medicines through clinical development and bring potentially life-changing therapies to patients.
Main responsibilities
You will:
Lead complex clinical projects involving multiple services, countries or regions.
Act as the principal contact for customers and manage expectations throughout the project.
Take responsibility for project quality, timelines, budgets, forecasts and resources.
Identify and manage risks, issues and changes to project scope.
Lead and motivate international, cross-functional project teams.
Ensure projects comply with company procedures, regulatory requirements and ICH-GCP standards.
Support proposal development, customer strategy and business growth opportunities.
Coach and develop project leaders and other colleagues.
Where applicable, manage employees, including recruitment, objective setting, performance management and career development.
Build trusted relationships with senior customers, internal leaders and key stakeholders.
Skills and experience
You should have:
A bachelor’s degree, relevant vocational qualification or equivalent practical experience.
Experience comparable to at least 10 years in clinical development, clinical research or a related field.
At least five years of management or significant leadership responsibility.
Strong knowledge of clinical development and relevant regulatory requirements.
Expert understanding of cross-functional project management, including time, quality and cost.
Experience managing budgets, forecasts, resources and contractual changes.
Excellent communication, presentation, negotiation and relationship-building skills.
The ability to lead, coach and motivate international teams.
Strong judgement, problem-solving and strategic thinking skills.
Confidence working in complex, changing or ambiguous situations.
Competence using Microsoft Office and relevant clinical project management systems.
A combination of suitable education, training and directly related experience may also be considered.
Working environment
This is a permanent, remote role based in Sweden. The position may also involve occasional work in office, laboratory or clinical environments, depending on project requirements.
Why join Thermo Fisher Scientific?
You will have the opportunity to lead important work, develop global talent and build a career with meaningful impact.
Role
Associate Director, Project Management Clinical Development
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover
and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare
disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments
currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered
in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Summary of Job:
The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and
continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North
America. The role leads the planning, development, review, and implementation of scientific materials and educational programs
that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific
information.
Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating
scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives,
and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to
ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates
cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned
with organizational priorities and compliant with applicable policies and regulatory requirements.
Essential Functions:
* Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical
congresses for U.S. Medical Affairs.
* Provide content and editorial support for regional publications and scientific presentations.
* Ensure regional publication priorities are represented in the global publication plan and support localization of global
publication activities to meet regional needs.
* Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with
regional medical strategy.
* Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific
communications deliverables.
* Support external expert engagement and steering committee activities, including coordination of content review and approval
workflows.
* Support scientific and medical operations, including advisory board planning and execution, medical information initiatives,
and Medical Science Liaison (MSL) training.
* Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed,
ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced.
* Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory
requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards.
* Perform additional duties and special projects as assigned.
Job Requirements:
Education
Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD,
PhD, DNP, or equivalent) required.
Experience
* Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or
Scientific Communications.
* Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions.
* Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory
boards, scientific symposia, medical education programs, publications, and congress deliverables.
* Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and
vendors to deliver high-quality scientific materials.
* Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical
development and medical congresses.
* Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology
environment.
* Rare Disease experience is strongly preferred.
Technical Skills
* Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International
Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements.
* Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information
to diverse internal and external audiences and facilitate cross-functional collaboration.
* Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint.
* Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting
scientific content development, review, approval, and distribution.
* Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate
complex scientific information into clear, accurate, audience-appropriate materials.
* Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data
visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements.
* Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver
high-quality work within established timelines.
Non-Technical Skills
Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a
fast-paced environment. Strong written and oral communication skills. Ability to work well in cross-functional teams (across
geography and culture) with a group of people with diverse skill sets and personalities. Team player, flexible and adaptable.
Ability to build good working relationships, both inside and outside the organization. Self-starter. Must possess integrity and
be innovative in how they work on a day-by-day basis. Has a passion for personal learning and development to be able to grow with
the company. Cultural sensitivity and ability to develop consensus within a multinational organization.
Physical Demands: Normal office environment with prolonged sitting and extensive computer work
Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional
weekend travel may be required.
The anticipated salary for this position will be $180,000 to $196,900. The actual salary offered for this role at commencement of
employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications,
education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational
needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a
comprehensive range of benefits including:
* 401K with company match
* Annual Bonus Program (Sales Bonus for Sales Jobs)
* Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
* Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
* HSA & FSA Programs
* Well-Being and Work/Life Programs
* Life & Disability Insurance
* Concierge Services
* Long Term Incentive Program (subject to job level and performance)
* Pet Insurance
* Tuition Assistance
* Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates
hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and
interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without
regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran
status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin,
Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing
kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com.
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include
setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise
needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data
Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller,
which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of
America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you
are located outside of the United States, your personal data will be transferred to the United States once you submit it through
this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by
regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application
for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal
data, to request that your personal data be rectified or erased, and to request that processing of your personal data be
restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have
any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
RECRUITMENT & STAFFING AGENCIES
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not
forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to
unsolicited resumes.
#LI-JC1
Join Us in Tackling Autoimmune Disease at Its Root
At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a
first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream
autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.
When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care.
Why Work at Vor?
Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple
autoimmune diseases.
Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial
strategy, and beyond.
Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across
lupus, IgA nephropathy, and Sjögren’s syndrome.
Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.
Who we are looking for:
Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune programs. The ideal candidate will
initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on
clinical operations strategy and related initiatives. The successful candidate will report to the Vice President, Clinical
Operations. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the
overall development programs and related studies to ensure the successful execution of assigned projects.
Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an
understanding of clinical drug development and clinical trials operations are essential.
Key areas of responsibilities:
* Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on
quality, including making recommendations and decisions regarding operational strategies to support study and/or program
objectives
* Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs
* Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan
* Support the selection, oversight, and management of CROs and other vendors
* Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
* Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure,
regulatory documents, clinical study reports, and other documents and plans as appropriate
* Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations
* Assist in forecasting clinical trial material and ancillary supplies
* Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with
operational standards and procedures
* Ensure timely review of protocol deviations and assess the impact on study data
* Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key
Opinion Leaders
* Perform and document study level Sponsor Oversight of outsourced clinical activities
* Communicate study status, cost, and issues to ensure timely decision-making by senior management
* Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to
clinical trial conduct
* Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma
* Support program level deliverables/activities at the discretion of the Head of Clinical Operations
* Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical
operations and functional area expertise
* Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company
SOPs and ensure all appropriate documents are filed
* Participate and respond to Quality Assurance and/or regulatory authority inspection audits
* Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in
conjunction with CRO and appropriate internal stakeholders
* Manage the clinical trial budget and provide financial reporting and projections to Finance
* Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and
Outsourcing as necessary
Qualifications:
* BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred
* Minimum of 8 years of experience in clinical research with at least 5 years of managing trials in the biotech/pharma industry
and/or prior CRO experience
* Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or
Myasthenia Gravis experience preferred
* Experience working on late-stage studies (Phase II, III)
* Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail
* Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet
deadlines, and proven effectiveness in a fast-moving and growing biotech environment
* Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials
* Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required
* Ability/willingness to travel as required
* Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech
or pharmaceutical industry
The salary range for this position is expected to be between $195,000 and $220,000 per year. Individual pay may vary based on
multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and
work location.
At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous
parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in
your well-being so you can thrive at work and beyond.
As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite
you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual
orientation, gender identity, national origin, veteran or disability status.
Please visit our website at https://www.vorbio.com/ for more information.
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer
therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the
design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes
varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a
clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are
also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Peer-to-Peer and Congress Marketing Lead will drive the strategy and execution of HCP engagement initiatives, including
peer-to-peer (P2P) programs and congress presence, in support of the U.S. launch of varegacestat. This role is responsible
for delivering high-impact educational programs, leveraging third-party engagements to generate actionable insights, and leading
integrated congress strategies to build company and brand awareness. Reporting to the U.S. Brand Lead, this position requires a
strategic marketer with strong scientific acumen, deep understanding of HCP engagement, and the ability to operate effectively in
a fast-paced biotech launch environment.
Responsibilities
Peer-to-Peer Strategy and Execution
* Lead the development and execution of the P2P strategy aligned to brand objectives and launch priorities.
* Design and manage speaker bureau programs, including content development, speaker training, performance tracking, and
partnership with the sales team to ensure execution excellence.
* Identify and execute P2P education opportunities (e.g., product theaters, satellite programs) to expand reach and enhance
impact through innovative formats.
* Own end-to-end execution of advisory boards, including objective setting, logistics, content development, stakeholder
alignment, and synthesis of actionable insights.
* Implement and manage third-party programs and external engagements to systematically gather HCP insights and inform brand
strategy.
* Develop HCP-facing derivative materials to support in-office and local program delivery.
Congress Strategy and Execution
* Own end-to-end congress strategy for key national and regional meetings.
* Lead the development of corporate booth strategy, design, and content for major medical congresses, ensuring alignment with
corporate and brand objectives.
* Develop field-facing congress tools and materials to support sales-led regional and local conferences.
* Establish and cultivate strategic partnerships with key national societies, identifying opportunities to enhance presence and
drive brand awareness.
* Drive integrated pre-, during-, and post-congress engagement strategies to maximize reach, insight generation, and return on
investment.
Qualifications
* Bachelor’s degree required; advanced degree (e.g., PharmD, MBA) preferred.
* A minimum of 5+ years of experience in pharmaceutical, biotech, or healthcare marketing, or equivalent; oncology experience
preferred.
* Oncology launch experience required.
* Proven track record in speaker bureau management, peer-to-peer program and advisory board execution, and congress planning.
* Strong understanding of MLR/PRC processes, claims substantiation, and OPDP regulations.
* Demonstrated ability to thrive in a fast-paced biotech environment.
* Ability to travel ≥30%, including occasional weekends.
Knowledge and Skills
* Deep understanding of HCP engagement strategies, including live, virtual, and hybrid formats.
* Strong analytical and problem-solving skills, with the ability to leverage market research and performance data to inform
decisions and optimize impact.
* Strong project management and operational execution skills; able to manage multiple workstreams and launch-critical deadlines
in a fast-paced environment.
* Excellent communication, storytelling, and presentation skills—able to simplify complex clinical information for varied
audiences.
* Experience managing agencies/vendors, budgets, and complex project plans with strong operational rigor and attention to
detail.
Washington State Pay Range - Senior Manager: $174,757 - $218,717
Washington State Pay Range - Associate Director: $185,400 - $232,037
Washington State Pay Range
$174,757—$232,037 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for
all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster
[https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk] | Right to Work Poster (English)
[https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e] | Right to Work Poster (Spanish)
[https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u].
