See Yourself at Telix
The Strategic Accounts Director is responsible for leading strategic business development to improve healthcare through diagnostic and therapeutic Oncology solutions that improve clinical outcomes. This role requires strategic leadership in high profile accounts. This is an exciting opportunity to network and build executive relationships, develop, and execute strategic plans and business partnerships. Drive a coherent strategy and optimize the use of resources to cover the market potential including strengthening current strategic relationships, build new strategic relationships, lead account and project management activities, coordinate Telix resources, and develop quarterly and yearly sales operating plans designed to exceed corporate goals. Monitor and analyze achievements against forecasts and expected success indicators.
Key Accountabilities
Analyze, develop, negotiate, and execute strategic contracts to gain market share
Develop strategic relationships and partnerships
Leverages project management expertise to guide the efforts and coordinate resources to creatively integrate and provide solutions to maximize market potential
Identify and develop new business opportunities
Create an environment of collaboration, uniting cross functional teams around common goals for our strategically important partnerships
Develop, execute, and lead rolling multi-year multi-faceted strategies
Ensure all financial matrix and performance exceed corporate goals
Motivate third party commercial activities to promote Telix products
Develop an in-depth knowledge including key competitors, terminology, technology, trends, challenges through network relationships and other sources to continuously increase market knowledge, and proactively initiate change to address changing market condition
Education and Experience
Bachelor's degree or degree of higher education in a healthcare field required; Master's degree preferred
10+ years of account management required; IDN experience preferred
Experience in Nuclear Medicine, Oncology or Urology, Strategic Account Management preferred
Knowledge of the US Integrated Delivery Networks, Academic Institutions, and GPO's
Ability to motivate cross-functional teams
Knowledge on Salesforce.com is a plus
Travel up to 50%
Accomplished leader with executive management experience
Project management leadership
Contract development, negotiation, and implementation
Proven comprehension in developing and driving strategic plans from concept to revenue generation
Experience working with third party partnerships
Proficiency in coordinating activities across multiple functional areas and multiple companies
Key Capabilities
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$118k-188k yearly est. Auto-Apply 6d ago
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Senior Medical Science Liaison - Southeast
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Sr. MSL serves as the field-based clinical and medical expert responsible for appropriately engaging in medical and scientific exchange and gaining insights in support of Telix Pharmaceuticals' products, research areas, and disease state of interest. The Sr. MSL will develop and maintain long-term, credible, peer-to-peer professional relationships with medical experts in the fields of oncology, urologists, radiologists, and nuclear medicine and other medical disciplines related to the diagnosis and/or management of patients within the Company products. Through scientific exchange, the Sr. MSL will communicate and advance the scientific platform aligned with the overall medical communications and Medical Affairs strategies.
*Candidates must reside in KY, TN, MS, AL, GA, FL, or PR
Key Accountabilities:
Identify and forge professional peer-to-peer relationships with National, Regional, and Local key opinion leaders
Align and execute field activities in support of Medical Affairs Strategic plan
Identify and communicate research gaps, opportunities, and relevant field intelligence to inform medical strategy
Accelerate recruitment efforts and enhance subject retention at targeted clinical trial sites
Leverage expertise to enhance and broaden knowledge among internal and external stakeholders
Attend medical/scientific meetings to represent Medical Affairs with KOLs and other HCPs, strengthen individual expertise/proficiency as well as capture, integrate, and summarize information of strategic interest
Appropriately facilitate submission of Medical Education grants and Investigator-Initiated Research
Support cross-functional colleagues (e.g. commercial, marketing, clinical operations), in appropriate activities
Actively participate in relevant team meetings, organizational activities, and HQ-driven medical affairs and clinical research activities (e.g. advisory boards, publication planning, investigator meetings)
Leveraging unique skill sets, assume lead responsibility for project work identified by Medical Affairs leadership and/or organizational priorities
Maintain a high level of team knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of Telix policies and procedures. Ensure all MSL activities, including external interactions, are conducted in accordance with Telix objectives, compliance policies and procedures as well as with legal and ethical standards
Education and Experience:
Advanced scientific, healthcare, or medical degree (PharmD, PhD, MD, RN) required
5+ years MSL experience
Experience in radiopharmaceuticals in prostate cancer is an advantage
Thorough understanding of relevant policies guiding the Pharmaceutical Industry
Experience/expertise in interpretation of scientific data, market research, and competitive intelligence tools.
Proficient in Microsoft Office Suite
Proven track record of delivering results that meet or exceed targeted objectives
Demonstrated ability to build productive collaborations with medical experts
Excellent verbal and written communication skills
Strong multi-tasking, time-management, organization and interpersonal skills, business acumen, and high level of emotional intelligence
Detailed knowledge of regulations and practices related to industry interactions with healthcare professionals.
Ability to take initiative and work both independently and in a team environment
Ability to quickly understand
Valid driver's license.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
Attention to Detail: Have a strong attention to detail and be able to pick up errors before they become issues whilst also maintaining a helicopter view and be able to prioritise
$58k-153k yearly est. Auto-Apply 26d ago
Service Sales Representative
Cross Company 4.1
Evansville, IN job
Purpose: The Service Sales Representative's mission is to develop new business within a defined territory. Service Sales Representative will communicate to customers and prospects the different aspects and capabilities of Cross and how it applies to their measurement needs. Service Sales Representatives are the primary field liaison between our customers and Cross and the primary business development resource for our company. This is an outside sales role designed for self motivated individuals who can work independently and with a team.
Measurables:
* New Service Business attained
* Growth of Assigned Service Territories
* Number of quotes created and percentage of quotes closed
* The creation of leads and the development of transitioning a lead to a customer
* Annual performance reviews
* Feedback from customers, prospects, and peers.
Activities and Responsibilities:
* Visit territory customers and prospects to:
* Develop and build the business that Cross does with that customer or prospect.
* Create opportunities to meet with customers and prospects and win their business.
* Identify the explicit needs of those customers that Cross can meet and identify the relative value of fulfilling those needs and determining the most effective way for Cross to meet that need.
* Develop presentations and communicate Cross' capabilities and how that adds value to them and their organization.
* Respond to customer's requests for quotes by submitting quotations to customers for measurement services, or turn the particular project over to the appropriate Applications Specialist, Inside Sales person, or Service Manager.
* Train the customer/prospect on the best, most effective way for them to interface with Cross to meet their needs.
* Gather feedback from customers on how Cross can improve what we do and communicate that feedback to the appropriate internal team member(s).
* Internal to Cross:
* Complete and submit all reporting, including quote logs, territory development plans, commission reports, etc on time and accurately.
* Participate in Sales and Service team meetings playing the role of team leader where assigned.
* Report to management market trends, competitive intelligence, and changes to customer's businesses that affect Cross
Position Requirements:
* Bachelor's degree in business or a related field preferred.
* 5-8 years of outside sales experience.
* Presentation, written and personal communication skills
* A focus on high quality outcomes and business profit
* Exceptional quantitative and analytical skills and PC proficiency
* The ability to think creatively, take initiative, multitask and manage projects under pressure
* An unwavering persistence, commitment, passion and enthusiasm for this work.
Compensation:
* Cross provides a competitive base salary as well as a commission structure that reflects effort and results.
* Cross provides the training and tools needed to succeed so that there is no out of pocket work related expenses.
Provided are:
* Company credit card
* Company shirts, jackets, and safety shoes
* Company computer
* Company smart phone
* Vehicle Stipend and mileage reimbursement
Benefits:
* Medical benefits live after 30 days
* 401K
* Employee Stock Ownership Plan
* 3 weeks accrued PTO
* volunteer days
* paid holidays
Experiential Representative, Golf | Indiana, Kentucky & Ohio
Contract Duration: February 2026 - July 2026
At Wilson, we are here to empower every human to live like an athlete. Passion. Creativity. Integrity. Teamwork. Ambition. Innovation. These are the qualities that have made Wilson Sporting Goods Co. the number one sports equipment brand in the world. We come together to win, grow, and celebrate. We all play for Team Wilson. We all have a role to play within our organization and are working towards the same goal. One team, one dream.
We believe that being an athlete isn't something you do, it's who you are. It's a universal code of conduct, a way of seeing the world and how you show up every day. We seek out diverse voices and welcome all perspectives. Our team is composed of individuals with unique backgrounds, points of view and experiences. These perspectives create a rich and diverse culture in which we learn from one another through empathy and inclusion.
Evolving the sports world and being the best partner for players, athletes, and our community is no small task. We are continually looking to add enthusiastic, ambitious, team-first individuals who desire to make a difference -and who love to help others win. Together, we will create a better world through sport. Join us.
What You'll Do
We are currently seeking a seasonal Experiential Representative to join our golf sales team. We're looking for a passionate golfer located in Indiana, Kentucky & Ohio to work full-time from Mid-February 2026 through July 2026.
The Experiential Rep will play a key role in executing grassroots initiatives for Wilson Golf. This person will work with the Regional Sales Manager, Territory Manager, and National Account Manager to achieve company sales, marketing, and distribution objectives in selected golf epicenters.
Specific responsibilities include, but are not limited to:
Work with Wilson Territory Managers to achieve company sales objectives through consumer events, fittings, marketing, and cultivating new & existing customer relationships
Work full 5 days a week, Tuesday-Saturday during agreed start and finish dates of employment
Plan, conduct, and report on fitting & trial events in Wilson's selected golf epicenters
Visit key accounts after event days and provide customer service related to merchandising, product and fitting training and building relationships
Develop partnerships with key and green grass accounts by engaging & training store staff
Provide accurate reporting metrics including sell through sales on an event-by-event basis
Build consumer relations through fitting appointments & on-site e-mail collection
Responsible for refreshing POP and marketing needs
Act as the main contact for providing images & consumer insights for social media
Partner closely with the in-store sales team to drive consumer sales and deliver an exceptional customer experience
Support and execute in-store events designed to increase product awareness, engagement, and sell-through
Assist with day-to-day activites, including product demonstrations, customer interactions, merchandising support, and general floor operations to ensure sales goals are met
What We're Looking For
We are looking for someone with a minumum 01 year of strong experience in golf sales and club fitting/building.
Other qualifications include:
Knowledge and interest in golf, as a means of developing authentic deliverables against a focused sports audience
Strong communication skills to effectively present information and work with cross-functional teams
Strong social skills necessary to network with the public and identify the untapped fitting customers for Wilson Golf
Demonstrated ability to influence, educate and sell the Wilson message to the golf consumer
Self-starter with demonstrated ability to work autonomously and take on a variety of tasks
Solid attention to detail with strong organization and project management skills
Ability to manage time working independently while balancing the need to be a team player that understands the value of a collaborative approach
Strong financial understanding with ability to manage budgets and control inventory
Willingness to create and drive change (entrepreneurial spirit)
Proven ability to work under pressure, prioritize and meet multiple deadlines
What We'll Provide
This fixed-term position pays $20-$22 per hour plus the opportunity to earn bonuses based on sales and new accounts. Mileage and overnights will also be covered.
Wilson Sporting Goods Co. is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, gender expression, protected veteran status, disability, or any other legally protected characteristics.
$20-22 hourly Auto-Apply 3d ago
Global Clinical Lead (Clinical Scientist)
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Global Clinical Lead will be accountable for the end-to-end clinical development of novel imaging agents within the FAP program, ensuring that clinical strategy is grounded in robust scientific rationale and aligned with commercial objectives. This includes the design and execution of clinical studies that generate high-quality data to support regulatory submissions, market access, and adoption by healthcare professionals, patient advocacy groups, payors, and strategic partners.
Working within a highly collaborative, matrixed environment, the Global Clinical Lead will partner closely with Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, and Commercial teams. The role requires a deep understanding of the competitive landscape and the ability to translate scientific insights into actionable development plans that accelerate the path to commercialization.
Key Accountabilities:
Lead Clinical Strategy Development: Define and drive the clinical development plans for Fibroblast Activation Protein (FAP) imaging assets, ensuring alignment with Telix's broader asset strategy and commercial objectives.
Cross-Functional Collaboration: Partner closely with Global Program Heads, Regulatory Affairs, Medical Affairs, and Translational Medicine to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of diverse stakeholders.
Clinical Study Design and Execution: Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
Clinical Documentation Leadership: Lead the creation and review of essential clinical documentation-including informed consent forms, imaging charters, study manuals, and regulatory dossiers-in collaboration with medical writers and cross-functional teams.
Regulatory and Scientific Contributions: Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs).
Data Integrity and Analysis: Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle.
Stakeholder Communication: Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights.
External Engagement and Thought Leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility.
Education and Experience:
Medical degree (MD) or doctoral degree (PhD) in a relevant scientific discipline is required.
Therapeutic Area Expertise: Demonstrated experience in oncologyor nuclear medicine is required, with a strong understanding of the clinical and scientific landscape.
Clinical Development Experience: 5 years of industry experiencein clinical development, with a proven track record of leading clinical programs through early-phase development. Experience in early-stage clinical trial design and execution is strongly preferred.
Regulatory Knowledge: Solid understanding of global clinical trial methodology, regulatory frameworks, and submission processes. Experience preparing and submitting regulatory documents (e.g., INDs, CTAs) and engaging with health authorities (e.g., FDA, EMA) is preferred.
Leadership and Project Management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs from concept through execution.
Strategic and Scientific Acumen: Strong knowledge of clinical trial design, data interpretation, and the ability to translate scientific insights into strategic development plans.
Key Capabilities:
Willingness to travel domestically and internationally, as needed
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
See Yourself at Telix
The CTS serves as the field-based clinical and is responsible for appropriately engaging with HCP's for optimizing clinical workflow integration of imaging within Telix theranostic pipeline including onboarding sites for Illuccix, prelaunch and post launch preparedness for TLX250-CDx and TLX101-CDx. The CTS will develop and maintain long-term, credible, peer-to-peer professional relationships with HCPs and medical experts in the fields of oncology, urologists, radiologists, and nuclear medicine and other medical disciplines related to the Company products. Through scientific exchange, the CTS will communicate and advance the portfolio aligned with the overall medical communications and Medical Affairs strategies.
**This role requires 75% travel and that candidates reside in the territory: NY, VT, NH, ME, PA, CT, MA, D.C.
Key Accountabilities:
The CTS will aid in new site onboarding, helping the site optimize settings and protocols to increase proper use of Telix radiopharmaceuticals in commercial setting and clinical trial setup.
Align and execute field activities in support of Medical Affairs Strategic plan
Identify and communicate research gaps, opportunities, and relevant field intelligence to inform medical strategy
Identify opportunities for medical team to present education and publications on disease state, real world experience and clinical trials.
Leverage expertise to enhance and broaden knowledge among internal and external stakeholders
Attend medical/scientific meetings to represent Medical Affairs by strengthen individual expertise/proficiency as well as capture, integrate, and summarize information of strategic interest
Appropriately support submission of Medical Education grants and Investigator-Initiated Research
Provide product training and presentations to internal and external stakeholders to ensure accurate communication and utilization of Telix products.
Support cross-functional colleagues (e.g., commercial, marketing, clinical operations), in appropriate activities
Support new site onboarding to ensure successful first and subsequent scanning
Actively participate in relevant team meetings, organizational activities, and HQ-driven medical affairs activities
Leveraging unique skill sets, assume lead responsibility for project work identified by Medical Affairs leadership and/or organizational priorities
Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and data with radiopharmaceuticals.
Maintain a high level of team knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of Telix policies and procedures. Ensure all CTS activities, including external interactions, are conducted in accordance with Telix objectives, compliance policies and procedures as well as with legal and ethical standards.
Maintain current clinical and professional certifications.
Collect and communicate competitive intelligence and insights through KOL interactions, and medical meetings.
Education and Experience:
BS or MS degree in scientific discipline (preferred Radiology or similar) or equivalent experience required
Certification by Nuclear Medicine Technology Certification Board (NMTCB) or the American Registry of Radiologic Technologist (ARRT) required
5 years of experience with advanced oncologic PET scanning and optimization required
Experience in radiopharmaceuticals required, prostate cancer preferred
Thorough understanding of relevant policies guiding the Pharmaceutical Industry
Experience/expertise in interpretation of scientific data, market research, and competitive intelligence tools
Proficient in Microsoft Office Suite
Proven track record of delivering results that meet or exceed targeted objectives.
Excellent verbal and written communication skills
Strong multi-tasking, time-management, organization and interpersonal skills, business acumen, and high level of emotional intelligence
Detailed knowledge of regulations and practices related to industry interactions with healthcare professionals.
Ability to take initiative and work both independently and in a team environment
Ability to quickly understand complex disease areas, treatments, and clinical development plans, healthcare landscape, hospitals, healthcare professionals, and patient journey
Valid driver's license.
Local, regional, and national travel up to 75%
Must live within close proximity to major airport
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$41k-54k yearly est. Auto-Apply 60d+ ago
Calibration Technician
Cross Company 4.1
Evansville, IN job
Responsible for performing quality calibrations adhering to corporate quality standards and procedures. Essential Functions: * Calibration encompassing the following core disciplines: Temperature, Pressure, Flow, Vibration, Mass, Electrical, Electronics, Time, Frequency, Radio Frequency, Torque, Force and Dimension. Additional training will be provided post-hire as needed.
* Prepare for all on-sites as assigned by Lead Tech or Service Manager; this includes reviewing equipment lists, procedures, specifications, and ensuring proper standards are selected for work assigned.
* Person must ensure he/she has calibration stickers, PMD work orders, worksheets, tags, cleaning supplies, directions, customer contact information and survey cards; downloading customer information to an on-site laptop may be required.
* Person must ensure all company issued tools and property are in proper working order and in calibration.
* Perform clerical work associated with calibration activities including certificates of calibration. Must provide the original data worksheet for final inspection by Quality.
* Perform quality inspection of calibrated equipment as approved by the Quality Manager.
* All certificates for equipment calibrated on-site and in house shall be completed in a timely manner (within 48 hours of job completion.)
* Keep in good order all tools and equipment, practice good housekeeping
* Maintain a safety and customer service mindset at all times
* Consistently maintain good work attendance and productive work ethic.
* Will perform other duties as assigned by the Service Manager
Minimum Requirements/Qualifications:
* A strong understanding of a wide variety of precision measurement equipment, to include the care and use of Instrumentation, Gages, and Precision Measurement Equipment; calibration program management, and Measurement Principles.
* Be proficient in gage management software
* Be computer proficient in all Microsoft Office applications
* Have a strong understanding of computer system peripherals and communication configurations
* Demonstrate excellent interpersonal and customer service skills
* Have excellent written and oral communication skills, both internally and externally
* Demonstrate self motivation, initiative, honesty, integrity, and attention to detail
* Have a valid driver's license and clean driving record
* Associates Degree in a technical discipline preferred; Instrumentation, Industrial, Mechanical, or Electronics Engineering, for example. Navy or Marine Corp GCAMS / ACTS , AF PMEL, or Army MOS - 94H Test Measurement & Diagnostic Equipment Support Specialist
Core Competencies
* Commitment to Excellence - Check your work
* Customer Relationship Management - communicate with customers to deliver better service
* Methodical Approach - troubleshooting
* Team Building
Physical Demands:
Stands greater than four hours at a time
May require walking 2 - 4 miles during an 8 hour period
Stoops and bends below knee level 2 - 4 times an hour
Lifts and carries less than 50 pounds but greater than 25 pounds repetitively
Climbs stairs more than four times in an eight hour shift
Pushes / pulls objects greater than 25 pounds
Reaches out
Reaches overhead
Repetitively uses feet
Repetitively uses hands (computer keyboard)
Grips with hands
$28k-32k yearly est. 37d ago
Global Development Lead
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Global Development Lead will lead a cross-functional matrix product team developing novel therapeutic radiopharmaceuticals in oncology. The role is accountable and responsible for creating, executing, and managing comprehensive drug development plans to advance compounds through early and late-stages to marketing authorization. Candidates must demonstrate strong scientific & technical leadership and the ability to lead and influence without authority. The ideal candidate will have prior experience leading project teams with external collaboration partners for oncology assets, preferably radiopharmaceuticals or other complex molecules.
Key Accountabilities:
Lead and collaborate in a cross-functional team environment to develop and commercialize radiopharmaceutical products.
Define (or participate in defining) and own joint program objectives.
Ensure documentation and execution of robust product development strategies and plans to achieve program milestones and value inflection points.
Navigate and lead teams through decisions, issues, risks, and mitigations.
Build team culture and identity to rally teams around the program vision, patients, and objectives
Oversight of Project Manager to ensure application of project management best practice, with the objective of progressing the Telix product portfolio through development within project timelines and budget.
Act as the primary point of contact for the programs and ensure that good communication is maintained both with
Internal product teams and with external product partners.
Complete oversight of the successful delivery of product development plans and product approvals, more specifically:
Maintenance of up-to-date documentation of product positioning and target product profile.
Progress tracking of all activities against the development plan and notification of potential delays and/or other changes.
Documentation and tracking of the Program budget; working with Finance and the project manager to ensure contracts and costs are recorded in an accurate and timely manner.
Work with senior management to assess product development risks and compile risk mitigation and scenario plans
Conducting regular reviews to ensure appropriate Program documentation is in place and to monitor project progress, scope, timelines and budget.
Ensuring all Program Team members and the Executive are kept informed of project status, costs and risks.
Supporting Project Managers in preparing periodic reports to internal stakeholders, including senior management, on the status and progress of the Program.
Ensure compliance with contractual obligations, regulatory requirements, and delivery of corporate objectives.
Preparing timely and accurate reports for Management.
Maintaining current awareness of Program-related scientific, clinical and commercial functional knowledge.
Education and Experience:
Bachelor's degree required; Master's or PhD strongly preferred
10+ years' pharmaceutical/biotechnology industry experience including direct experience in oncology drug development required
5+ years' project and budget management experience required
Experience leading teams in global partnerships or co-development agreements is strongly preferred
Prior experience working with radioconjugates or antibody drug conjugates (ADC) is strongly preferred
Experienced in therapeutic oncology drug development
Understanding of the regulatory environment in the US, EU and APAC
Experience working as part of, and leading, cross-functional teams
Key Capabilities:
Inclusive mindset
: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation
: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence
: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented
: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior
: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability
: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills
: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration
: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience:
Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning
: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$97k-134k yearly est. Auto-Apply 54d ago
VP, Medical Affairs Americas
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
In collaboration with executive Americas (US, Canada, and LATAM) leadership and cross-functional global matrix leadership teams, this person will define medical affairs' strategy and goals. They will oversee operations, budget and tactical execution, while maintaining Medical Affairs excellence, policies and procedures. He/she will advance collaborations with key opinion leaders and establish and execute strategic plans for scientific engagement with health care practitioners, research groups, and centers of excellence.
The VP, Medical Affairs - Americas leads strategy and tactical execution across assets and manages a team of Medical Directors with direct reports (field medical liaisons and clinical theranostic specialists). They are accountable for clinical trial recruitment strategies to support on time development Ph1-Ph4 registrational trials, expanded access programs, and lifecycle management. They are an expert across the Telix portfolio and are considered a SME.
Finally, they will work closely with internal department stakeholders including clinical development, clinical operations, marketing, market access, global medical communications, pharmacovigilance, and the commercial department to provide Medical Affairs input to product development and launch strategies across lead assets for Americas regions (US, Canada, LATAM).
Key Accountabilities
Lead Medical Affairs strategy and execution across Americas (US, Canada, LATAM) aligned and to support commercial/marketing departments and corporate objectives within clinical pipeline and commercial launches.
Responsible to ensure Illuccix, Zircaix, and Pixclara launches through clinical mindshare, regional publication data gap needs, robust IIT strategy and execution end to end, reader training development and implementation success, medical information request follow up and support regional standard response letters within the respective region.
Stay abreast across current guidelines, key publications to drive clinical efficacy positioning, competitive intelligence training across Medical Affairs team for consistent communication.
Strong communication plan and oversight around initiatives to internal and external stakeholders.
Responsible for the clinical strategy and support Marketing materials development, sales training, and Medical Review in Veeva for internal and external facing stakeholders within the respective region.
Lead scientific engagement strategy with key opinion leaders (KOLs), healthcare providers, professional societies, and delivery of medical education and scientific communication
Develop metrics for KOL engagement by guidelines, institutions, subspecialty across various regions, ability to shift and make decisions and inform cross functional strategies that are data driven.
Strong publication and congress strategy and execution. Podium strategy includes properly preparing speakers prior to podium.
Support the expansion of theranostic clinical practice through evidence generation, data gap identification and dissemination, and collaborative partnerships, opportunities, and relevant field intelligence to inform medical/clinical strategy and cross functional stakeholders.
Identify data gaps for payors, HCP unmet need, guidelines, societies, lead publication strategy and timelines in collaboration with med comms
Accelerate recruitment efforts and enhance subject retention at targeted clinical trial sites and support lifecycle management.
Responsible for clinical trial recruitment strategies to accelerate on time trial milestones. Work closely with clinops to identify gaps with sites and patient accrual. Develop metrics to inform and stay on target.
Drive medical/scientific meetings, site engagement meetings. Lead advisory boards in colloboration with development needs. Support Investigator meetings with high collaboration and coordination with clinops. Capture, integrate, inform cross-functional strategies for lifecycle management
Lead Investigator-Initiated Research strategy and matrix alignment needs across development, regulatory, clinical, and marketing.
Expert knowledge of Telix pivotal trial designs, IB, and ability to review and inform as a Medical lead on protocol design from MA perspective of where the field is moving and KOL feedback, adding value to clinical relevance.
Maintain a high-performance team with tactical execution, clear strategy, and operational excellence.
Metric for performance coaching and metrics around team performance, team meetings
Accountable for team SME training and expectations across portfolio, literature, key trials, and competitive intelligence. Including abreast of Telix investor presentations and competitors. Develop SME plan, expectations and metrics for team SME
Maintain a high level of team knowledge of and appropriately implement current local pharmaceutical regulation and ensure implementation of Telix policies and procedures. Ensure all MSL activities, including external interactions, are conducted in accordance with Telix objectives, compliance policies and procedures as well as with legal and ethical standards.
Education and Experience
Advanced scientific, healthcare, or medical degree (ex: PharmD, PhD, MD) required.
10+ years' experience in biotech, pharma or related areas required.
5+ years in a leadership role required.
Expertise in Prostate, Renal, and Neuro-Oncology radiopharmaceuticals strongly preferred.
Demonstrated success in fostering close partnerships across functions and diplomacy.
Ability to travel of 50-75% regionally. International travel may be requested.
Comprehensive knowledge of in-depth medical affairs activities including key pivotal trials and medical landscape of prostate, renal, and neuro-oncology.
Experience in a pharmaceutical environment with strong knowledge of relevant compliance and regulatory environment.
Proven track record in the areas of medical strategy, product launches, lifecycle strategy, data generation gaps, and thought leader engagement.
Experience with package insert development, trial designs of EAP and Registries.
Ability to lead, inspire and influence a US MA team, functioning in a matrix structure, through vision and strategy setting.
Self-reflective and aware of their own limitations, a great listener, open to feedback and self-improvement.
Demonstrated business acumen; excellent people management and leadership skills, able to manage complex technical organizations.
A proven ability to execute and get results through leading others whilst leading by example.
Demonstrated ability to build successful relationships and develop partnerships with key business partners and investigators.
Strategic thinking and innovative mindset.
Strong interpersonal and communication skills, forging relationships with various internal and external stakeholders.
Strong multi-tasking, highly detailed oriented and organizational skills with great consistency is a must.
Excellent written and verbal communication, organization, and cross-functional collaboration skills.
$103k-154k yearly est. Auto-Apply 60d+ ago
Key Account Specialist (Food Broker)
Affinity Group 4.0
Indianapolis, IN job
Key Account Specialist (Food Broker)
Affinity Group is seeking a sales-driven, business development influencer to be our next Key Account Specialist to spearhead growth in our Indiana market. This is a great opportunity for a passionate professional with an entrepreneurial spirit. This position will be reporting to the Market Manager.
Who We Are:
Great Place to Work Certified | Your Bridge to Success | Why Our People Love Affinity Group
Affinity Group is one of the fastest-growing food sales and marketing agencies, with a national presence throughout North America. We represent some of the most recognizable and well-regarded food brands in the industry, and bring decades of expertise and a consultative system that is tailored for a localized approach. Supported by the corporate sales support team, you'll be part of a team that drives brand awareness and increases market demand for our clients.
Perks & Benefits:
Health, vision, and dental insurance
Life insurance and disability benefits
401(k) retirement plan
Paid time off and company holidays
Employee discounts (National Purchasing Partners)
Competitive pay + bonus potential
What You'll Do:
Develop and execute plans to boost brand awareness and generate sales
Influence decision-makers in the foodservice industry, from restaurant owners to culinarians
Participate in food shows
Deliver impactful sales presentations and consultations to drive market sales growth
Manage sales pipeline and ensure CRM data integrity
What to expect:
The typical work week: Monday through Friday
During the food trade show season, the position requires the ability to stand for extended periods, with the ability to safely lift case goods (up to 50 lbs.)
Travel (Driving): Position requires daily motor vehicle travel to assigned locations. The candidate must possess an active Driver's License and a clean driving record
Qualifications:
Preferably 3-5 years in foodservice sales or operations; culinary experience is a plus!
Strong ability to connect with professionals at all levels
Creativity in recommending menu ideas and a deep love for the culinary world
A driven, proactive approach to client relationships
Bonus Points For:
An associate or bachelor's degree
Experience with CRM systems
The Affinity Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
All employment is decided on the basis of qualifications, merit, and business need.
$31k-39k yearly est. Auto-Apply 12d ago
Medical Writer
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development.
This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.
Key Accountabilities:
Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments.
Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly.
Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
Collaborate with project teams to respond to heath authority questions and requests.
Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline.
Education and Experience:
Bachelor of Science a science or related field required; Advance degree preferred
5+ years of experience in regulatory medical writing required
Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must.
Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy.
The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required.
Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting.
Experience and proficiency with document templates, document toolbars and proper version control.
Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$53k-77k yearly est. Auto-Apply 60d+ ago
Principal Scientist, Biologics
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
This role provides technical and analytical expertise for late phase biologics process development and commercial manufacturing activities for multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) ensuring manufacturing processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing projects in multiple technological areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) at external CDMO partners, as well as contributing to internal cross-functional collaborations to develop and execute clinical and commercial manufacturing.
The Principal Scientist, Biologics acts as the Biologics lead for a specific therapeutic program and should be comfortable communicating with cross-functional teams in formal settings and third-party meetings, be knowledgeable in several technical areas as well as their focus technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation), and manage their own workload to complete assignments autonomously with some feedback from senior-level colleagues and/or their manager for more complicated topics.
Key Accountabilities:
Leads development projects for multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) ensuring the appropriate process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation to produces clinical and/or commercial drug substance.
Authors, reviews, and approves external manufacturing operation documents such as SOPs, batch records, protocols, and reports for multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance.
Ensures appropriate compliance of multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
Authors and/or reviews source documents and CMC content related to several technology areas (e.g. cell culture, purification, formulation, or bioconjugation) to support IND, NDA, BLA and similar regulatory agency applications, especially in areas requiring more sophisticated acumen such as comparability and risk-based approach justifications.
Leads collaborations with external partners such as CDMOs to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, and manages timely deliverables.
Experience in the commercialization of several programs from last cycle process development including optimization, process characterization, robustness, reproducibility, through process validation (process definition/ lock, PPQ, & CPV).
Mentors Senior Scientists and other level Scientists on both technical topics as well as Telix values.
Education and Experience:
Science or engineering degree with minimum relevant experience as applicable: BS with 11+ years of experience, MS with 9+ years of experience, PhD with 8+ years of experience.
6+ years of experience in GMP, quality management system, and CMC compliance and regulation.
Demonstrated understanding and application of project management principles and tools.
Ability to work in cross-functional, virtual teams.
Travel expectation: 10 - 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments.
Key Capabilities:
Inclusive mindset
: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation
: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence
: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented
: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior
: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability
: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills
: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration
: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience:
Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning
: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$93k-131k yearly est. Auto-Apply 60d ago
Manager, Global Regulatory Affairs - CMC
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Manager, GRA - CMC is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. The Manager RA CMC will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.
Key Accountabilities:
Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.
Education and Experience:
Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
7+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills
$66k-110k yearly est. Auto-Apply 56d ago
VP, Global Clinical Operations
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Vice President, Global Clinical Operations (VP, GCO) is a senior leader responsible for leading Telix's global clinical operations strategy and execution across the company's diagnostic and therapeutic radiopharmaceutical portfolio. This role oversees all aspects of operational planning, program delivery, vendor and site management, and inspection readiness to ensure high-quality, compliant, efficient clinical trial execution across all clinical trial phases (Phase I-IV including expanded access and registries) are managed and executed in alignment with Telix's overall program goals, timelines, budgets, and quality expectations. The VP, GCO partners closely with Clinical Development, Medical Affairs, Regulatory Affairs, CMC, Manufacturing/Supply Chain, and Commercial to enable timely development of Telix's pipeline and support global registration efforts.
The individual ensures that Telix maintains excellence in clinical execution, operational governance, quality, patient safety, financial stewardship, and cross-functional alignment across all regions (North America, Europe, APAC, and Japan).
The VP, GCO is accountable for the adherence to Good Laboratory Practice (GLP), ICH guidelines, Good Clinical Practice (GCP), and local regulatory guidelines, laws, and relevant company Standard Operating Procedures (SOPs). The VP, GCO will play a crucial role in contributing to the achievement of Telix's strategic goals by providing senior leadership, management, and development of the Clinical Operations function to ensure efficient outcomes for the Company's clinical studies.
Key Accountabilities
Strategic:
Leadership and Operational Oversight: Provide leadership and direction to the Global Clinical Operations function, ensuring alignment with Telix's overall program goals and objectives. Develop and communicate the vision and goals for the department.
Operational Strategy: Develop and implement the operational strategy for Telix's Company-sponsored clinical trial implementation, execution, monitoring, analysis, data delivery, and clinical dossiers for regulatory submission. Drive process improvements and efficiencies to optimize the conduct of clinical trials. Lead operational risk assessment and mitigation strategies across the portfolio.
Team Management and Development: Lead and manage a team of Clinical Operations professionals and their respective teams and functional consultants of Clinical Operations, providing guidance, mentorship, and support. Establish SOPs, governance and metrics. Foster a culture of collaboration, innovation, and continuous improvement within the team.
CRO, Vendor & Performance Management: Lead the end-to-end selection, contracting, onboarding, and performance oversight of CROs (bandwidth of multiple trials) and critical vendors. Establish and maintain a formal CRO governance model including executive business reviews, KPIs, ongoing risk assessments, and performance scorecards. Ensure CRO accountability for quality deliverables, timelines, enrollment performance, TMF completeness, monitoring metrics, site engagement, and budget adherence. Drive escalation pathways and root cause analyses to address performance issues with urgency and transparency.
Site & Investigator Engagement: Build strong, collaborative relationships with global KOLs, investigators, selected sites. Oversee operational feasibility, site onboarding, study training, and investigator communication to optimize enrollment performance, and resourcing needs.
Tactical:
Trial Execution and Oversight: Oversee end-to-end execution of Telix-sponsored clinical trials, including feasibility and site selection strategy, contracting, study start-up, monitoring, data collection, database lock, and study close-out. Ensure studies are conducted in accordance with GLP, ICH guidelines, GCP, local regulatory guidelines, laws, and relevant Company SOPs. Monitor trial progress, identify risks, and implement mitigation strategies.
Stakeholder Collaboration: Collaborate closely with cross-functional Program teams, including regulatory affairs, medical affairs, research and innovation, manufacturing and other relevant functions, to ensure effective coordination and alignment in clinical trial activities. Foster strong relationships with external stakeholders, such as clinical research organizations (CROs) and investigational sites.
Inspection & Quality Excellence: Ensure the organization is standardized and consistently inspection-ready across all studies and vendors. Partner with Quality to oversee TMF health, monitoring oversight, protocol deviations, and corrective/preventative actions (CAPA). Lead operational responses and readiness for regulatory inspections (FDA, EMA, PMDA, MHRA, etc.).
Resource Allocation and Budgeting: Allocate resources effectively and efficiently to support the successful execution of clinical trials. Develop and manage the function's operating budget, ensuring optimal utilization of resources.
Risk Management: Identify and mitigate risks and issues that may impact trial timelines, budget, or quality. Implement risk management strategies and contingency plans to minimize potential disruptions.
Regulatory Compliance: Stay updated with the evolving regulatory landscape and ensure adherence to local and international regulatory requirements. Proactively address any compliance issues and drive continuous compliance improvement within the Clinical Operations function.
Leader of People:
Advocate for and instill within the Global Clinical Operations team the importance of Telix's values: Everyone counts; we strive to be extraordinary; we act with determination and integrity.
Demonstrate leadership for Telix's quality, governance, and compliance systems through active promotion of standards and procedures and ensure that team members are suitably trained and developed to perform roles effectively and safely.
Take an active interest in team members and their well-being, and endeavor to attract, develop and retain the best talent, to deliver Telix's current and future business objectives.
Position Requirements
Education:
Bachelor's degree required; Advanced degree in life sciences, pharmacy, nursing, or related field strongly preferred
Experience:
15+ years' experience in Clinical Operations experience in the pharmaceutical/biotech industry or equivalent experience including 7+ years in senior leadership roles required.
Experience in oncology required; radiopharmaceutical or imaging-based clinical studies strongly preferred.
Extensive experience in managing and leading teams, including experience in a leadership role within Clinical Operations.
Strong knowledge and understanding of region-relevant clinical trial regulations, guidelines, and industry standards, including GCP and applicable local regulations.
Proven track record of successfully leading the execution of clinical trials (Phase I-IV), generating and compiling the clinical components of a regulatory submission, managing multiple programs, and ensuring adherence to timelines, budgets, and quality expectations.
Expert in working with cross-functional teams and collaborating with other functions such as regulatory affairs, medical affairs, finance and research and development.
Broad experience with the development and implementation of clinical operational strategies, processes, and best practices.
Broad experience in risk management, compliance, and quality assurance within clinical operations.
Demonstrated ability to drive innovation, process improvement, and operational efficiencies within clinical trial execution.
Experience of interacting with regulatory agencies in preparation for, and during clinical audits.
Excellent negotiation, communication, and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders.
Self-motivated, goal-oriented, and able to work independently as well as collaboratively within cross-functional teams.
Willingness to travel domestically and internationally, as needed.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$47k-88k yearly est. Auto-Apply 31d ago
Director, Biologics
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The role of Director, Biologics will oversee process development and clinical production of radiolabeled monoclonal antibodies and conjugates within Telix's Global Operations organization. This leadership position is responsible for guiding late-phase development and commercialization strategy, managing a team of bioprocess and bioconjugation scientists and engineers, and ensuring readiness for scale-up and manufacturing. The role will play a critical part in advancing Telix's biologics programs through clinical development and toward commercial launch.
Key Accountabilities:
Provide direction for late phase process development, validation, and commercialization strategies including timeline, resource plans, and key evaluations. Oversee the process development and validation activities, ensuring alignment with corporate objectives.
Lead and motivate a team of bioprocess and bioconjugation scientists and engineers, fostering a culture of collaboration, compliance, and technical excellence. Demonstrate Telix values, leadership competencies, and industry methodologies, platforms, and best practices. Mentor team members on evaluation and execution for activities such as late-stage process development, process characterization, technology transfer including analytical methods, risk assessments, and validation.
Manage relationships with internal and external partners including CDMOs and consultants, ensuring project requirements and external partner capabilities align to support production, optimization, and scale-up. Responsible for scoping, negotiation, budgeting and contracting of external activities. Guide team members' support of clinical manufacturing activities such as production forecasts & planning, NPI & GMP readiness, and batch release.
Ensure Biologics deliverables comply with GMP requirements across multiple regions. Uphold GxP standards, especially documentation within our internal QMS and within external partner GMP manufacturing QMS including technical input to capture investigations, root cause analysis, and other quality events.
Engage directly in cross-functional program matrix teams by providing options analysis and program timeline input. Support & mentor team members ensuring execution to plan and timely notification of issues and risks. Contribute to the creation of process development, technology transfer, and validation plans within a CMC stage gate framework.
Ensure appropriate source documentation to support regulatory filings, as well as review Module 3 CMC content for IND/IMPD, BLA, & MAA, and other regulatory documents. Contribute key inputs to regulatory strategy for late-stage CMC topics, including areas requiring more sophisticated acumen such as comparability and risk-based justifications.
Participate in efforts for optimization of internal business processes including input on key CMC deliverables. Generate presentations, storyboards, and written documentation related to complex technical content for internal and external stakeholders.
Education and Experience:
Bachelor's degree plus 17 years of experience, or Masters degree or PhD plus 10 years of experience, in bioprocess development, validation, and commercialization.
5+ years in leadership, ideally managing global teams and external partners (e.g., CDMOs)
10 years of experience in GMP, quality management system, and CMC compliance and regulation.
Strong written and verbal communication skills are required.
Experience working with radiolabeled antibodies is preferred.
Experience of contributing to regulatory filings is preferred.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$72k-107k yearly est. Auto-Apply 54d ago
Finance Director - Therapeutics
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The key purpose of this role is to partner with the Clinical, Manufacturing and Development teams to manage the financial performance reporting, budget preparation and activity forecast, and ensure effective R&D project cost management to plan. The incumbent will achieve this through effective financial planning and assessment of anticipated costs and outlays and manage key reporting and tracking as well as ensure effective systems and reporting of the investment in the product portfolio. This role helps identify effective inputs, controls, reporting and systems with the Project Management Office (PMO) to ensure effective financial delivery to plan. The Finance Director, Therapeutics also helps support cyclical financial, accounting and corporate reporting for R&D projects and portfolio teams in line with Telix reporting cycles and deliverables.
Key Accountabilities
Effective financial management reporting and review of performance to plan for Telix's development pipeline of Therapeutic products.
Partner with key internal stakeholders to review financial performance to plan on key projects in the development pipeline.
Review reporting inputs and requirements to ensure effective tracking and project management tools in place.
Develop action plans accordingly to align projects costs to plan.
Preparation and planning of project budgets, forecast of activity, tracking of R&D expenditure, and capital investment in line with commercial agreements.
Partner with key internal stakeholders to prepare budget plans and activity forecasts for project needs through to sign off and implementation.
Ensure effective reporting systems and tools in place to anticipate and capture project activity and key reporting including cash forecasts, milestone payments and funding requirements.
Ensure financial outlay and performance in line with commercial agreement expectations and scope.
Cyclical reporting and review of financials and performance for month end, quarterly and annual review processes for project, financial, accounting and corporate reporting requirements.
Ensure effective period end reporting for financial and management accounting review - monthly, quarterly and annual reporting cycles.
Input and assistance preparing reporting and project reviews for Board and Executive review.
Input and support audit and compliance reporting and requirements for financial statutory accounts.
Partnering with the CEO - Therapeutics to model and prepare costing / financial analysis on strategic initiatives, commercial partner proposals, project amendments and future opportunities.
Partner with key stakeholders to undertake financial review and assessment of project scenarios, proposals and costing on key project initiatives.
Provide input and review of key commercial arrangements and project contracts through the product development lifecycle.
Ensure effective financial systems, processes, procurement assessment and support, internal controls and adherence to corporate policies and SOX.
Partner with PPM team and key partners to assess project reporting against organization requirements and implement key tools and systems to ensure effective tracking and reporting for PPM team and network partners.
Implement effective financial controls as appropriate to ensure performance to plan and Telix policy.
Ensure compliance with SOX requirements and adherence to internal control policies across financial reporting and project related financial activities
Implement and maintain SOX-compliant processes and internal controls, ensuring accurate and transparent financial reporting.
Ensure all financial data, including R&D expenditures and capital investments, is compliant with SOX and undergoes the appropriate level of review.
Collaborate with internal and external auditors to ensure proper SOX documentation, control testing, and compliance reviews.
Position Requirements
Qualifications:
Bachelors' degree in Finance or Commerce with post qualification professional accounting certification (CPA or CA) required
Strong demonstrated career experience in a global public organization.
Sound commercial acumen and financial management skills and experience, gathering and analyzing data, reports and presenting findings and recommendations to senior management and key stakeholders.
Previous demonstrated experience supporting large scale R&D projects with key internal stakeholders and external partner or network organisations. Understanding of project costing, capital and investment will be well regarded.
10+ years of experience in financial reporting to monthly, quarterly, and annual cycle requirements including corporate, compliance and audit requirements.
Experience in pharmaceuticals or biotechnology sectors will be highly regarded.
Preferred Attributes:
Experience in biotechnology or pharmaceutical sectors
Knowledge of ERP systems, particularly SAP
Ability to manage multiple projects and priorities in a fast-paced environment.
Detail-oriented with a commitment to accuracy and quality.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
$87k-129k yearly est. Auto-Apply 26d ago
Senior Manager, Global Regulatory Affairs - CMC
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Senior Manager, GRA - CMC is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. The Senior Manager RA CMC will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.
Key Accountabilities:
Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.
Education and Experience:
Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred.
9+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry.
Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks.
Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3.
Key Capabilities:
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills
$85k-119k yearly est. Auto-Apply 56d ago
Director, Upstream Product Marketing - Early Stage PSMA
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Director, Product Marketing - Upstream Early-Stage PSMA is a senior strategic leader responsible for shaping the future of Telix's PSMA imaging portfolio by driving the early-stage commercial strategy for next-generation diagnostic products. This role leads opportunity identification, commercial hypothesis development, and pre-PMC business case creation to ensure that early concepts are clinically meaningful, commercially viable, and aligned with Telix's long-term franchise strategy. As Director, you will partner closely with Global Development Leads (GDLs), Commercial Strategy & Operations, Medical Affairs, Business Development, and regional commercial teams to define target product profiles (TPPs), influence clinical plans, and guide the strategic direction of Telix's early PSMA innovation pipeline.
Key Accountabilities:
Strategic Opportunity Leadership & Early Commercial Strategy
Lead regional opportunity and identification for new PSMA imaging concepts aligned with Telix's long-term franchise and portfolio strategy.
Direct comprehensive market assessments to quantify unmet needs, commercial potential, and competitive advantage.
Own the development of early commercial strategy, articulating long-range positioning, market differentiation, and value creation pathways.
Define and guide Target Product Profiles (TPPs) in collaboration with GDLs and Medical Affairs to ensure development programs are grounded in customer and market needs.
Engage regional leaders to gather, analyze, and integrate early customer insights that shape development priorities and early-stage decision-making.
Business Case Ownership & PMC Influence
Lead the creation of high-quality, strategic business cases for early PSMA opportunities, including TAM/SAM models, adoption scenarios, and value assessments.
Collaborate with Commercial Strategy & Operations to develop and challenge early financial models, forecasts, and scenario planning.
Shape early pricing, access, and reimbursement assumptions to ensure commercial feasibility.
Present strategic recommendations to leadership, governing bodies, and PMC pre-review forums to influence go/no-go investment decisions.
Ensure early-stage programs are well-prepared for seamless transition into late-stage development.
Cross-Functional Leadership & Early Development Integration
Serve as the senior commercial lead for early-stage PSMA programs, ensuring commercial guidance is deeply integrated into clinical and regulatory strategies.
Partner with GDLs, Medical Affairs, and Clinical Development to influence protocol direction and evidence-generation priorities.
Lead alignment across regions, ensuring early-stage insights, voice-of-customer (VoC), and market requirements are consistently communicated and embedded in development planning.
Provide early strategic guidance to downstream marketing teams to facilitate long-term brand and launch planning
Market Intelligence, Pipeline Monitoring & Strategic Foresight
Provide competitive intelligence and foresight on emerging PSMA technologies, clinical trends, and pipeline dynamics.
Identify early opportunities and risks that could influence Telix's future positioning, lifecycle strategy, or partnership pathways.
Develop strategic dashboards and intelligence briefs for senior leadership to support portfolio decisions.
Collaborate with Corporate Strategy and BD on partnership evaluations, external innovation scans, and potential licensing opportunities.
Strategic Program Management & Portfolio Leadership
Lead cross-functional strategic initiatives and early-stage commercial workstreams, ensuring disciplined execution and timely delivery.
Manage governance routines, executive updates, and decision-making materials for early development and portfolio prioritization.
Provide commercial rigor, clear risk-benefit evaluation, and customer-driven rationale to support strategic prioritization across the pipeline.
Education and Experience:
Bachelor's degree in Marketing, Business, Life Sciences, or related field; MBA or advanced degree strongly preferred.
8-12+ years of relevant experience in pharmaceutical, biotech, diagnostics, business development, or strategic marketing.
Significant experience in upstream, early product strategy, or franchise-level portfolio planning-preferably in oncology, urology, or molecular imaging.
Strong analytical capabilities with demonstrated expertise in forecasting, TAM/SAM modeling, and business case development.
Proven ability to translate complex scientific, clinical, and market insights into actionable commercial strategy.
Demonstrated leadership and influence across matrixed organizations.
Exceptional communication skills, with the ability to present recommendations to senior and executive leadership.
Strong program leadership, prioritization, and decision-making skills in fast-paced environments.
Success Metrics
Delivery of strategic, evidence-based business cases that shape PMC decisions and portfolio direction.
Strong alignment between early-stage development plans and long-term commercial strategy.
Clear, data-driven opportunity assessments that strengthen portfolio prioritization.
Successful progression of early PSMA programs into late-stage development with validated commercial hypotheses.
Recognition as a trusted, strategic partner to GDLs, Medical, Commercial Strategy, and regional PX teams.
$97k-147k yearly est. Auto-Apply 32d ago
Key Account Specialist (Food Broker)
Affinity Group 4.0
Indianapolis, IN job
Job Description
Key Account Specialist (Food Broker)
Affinity Group is seeking a sales-driven, business development influencer to be our next Key Account Specialist to spearhead growth in our Indiana market. This is a great opportunity for a passionate professional with an entrepreneurial spirit. This position will be reporting to the Market Manager.
Who We Are:
Great Place to Work Certified | Your Bridge to Success | Why Our People Love Affinity Group
Affinity Group is one of the fastest-growing food sales and marketing agencies, with a national presence throughout North America. We represent some of the most recognizable and well-regarded food brands in the industry, and bring decades of expertise and a consultative system that is tailored for a localized approach. Supported by the corporate sales support team, you'll be part of a team that drives brand awareness and increases market demand for our clients.
Perks & Benefits:
Health, vision, and dental insurance
Life insurance and disability benefits
401(k) retirement plan
Paid time off and company holidays
Employee discounts (National Purchasing Partners)
Competitive pay + bonus potential
What You'll Do:
Develop and execute plans to boost brand awareness and generate sales
Influence decision-makers in the foodservice industry, from restaurant owners to culinarians
Participate in food shows
Deliver impactful sales presentations and consultations to drive market sales growth
Manage sales pipeline and ensure CRM data integrity
What to expect:
The typical work week: Monday through Friday
During the food trade show season, the position requires the ability to stand for extended periods, with the ability to safely lift case goods (up to 50 lbs.)
Travel (Driving): Position requires daily motor vehicle travel to assigned locations. The candidate must possess an active Driver's License and a clean driving record
Qualifications:
Preferably 3-5 years in foodservice sales or operations; culinary experience is a plus!
Strong ability to connect with professionals at all levels
Creativity in recommending menu ideas and a deep love for the culinary world
A driven, proactive approach to client relationships
Bonus Points For:
An associate or bachelor's degree
Experience with CRM systems
The Affinity Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
All employment is decided on the basis of qualifications, merit, and business need.
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$31k-39k yearly est. 13d ago
Senior Project Manager
Amer 4.2
Amer job in Fishers, IN
See Yourself at Telix
The Senior Project Manager will support development and commercial leadership in executing the strategic vision for a priority therapeutic program, ensuring alignment with PMO best practices broader business strategies. This role involves overseeing cross-functional teams to ensure the effective planning and execution of drug development initiatives. The position requires managing end-to-end a late-stage high-priority program, driving timely delivery and quality outcomes. The Senior Project Manager will collaborate closely with senior leadership to define and implement solutions, project strategies, budget management, and achieve objectives timely, while ensuring clear communication and alignment across stakeholders at multiple levels.
Key Accountabilities
Manage all aspects of the product development plan including activity planning, budgets, schedule adherence, resourcing, and milestone reporting.
Engage with senior leadership to define project strategies and objectives and provide leadership for complex, multi-faceted projects spanning multiple functional areas.
Support alignment of project goals with the company's strategic objectives.
Actively maintain internal Project Management software (SmartSheet), ensuring consistent accuracy in scheduling, risk assessment, and team data integrity.
Work with Project Team to develop, maintain, and report all project schedule information and baselines using standardized dashboard reporting.
Facilitate regular project update meetings with the Project Teams.
Quantify associated cost and schedule changes for submission to change management.
Contribute to integrated project teams across a matrixed organization.
Develop and manage key cross-functional reporting relationships to ensure project information traceability to other systems.
Proactively identify and mitigate risks to ensure smooth project progression. (This could be included if it is not covered under "risk assessment.")
Maintain ongoing communication with key stakeholders to ensure alignment and visibility on project progress and potential challenges.
Act as key internal contact for projects under your supervision.
Work collaboratively with department leadership to ensure all reporting is met.
Manage complex, late-stage, high-priority programs independently.
Coach, review, and delegate work for team members and/or other PMO staff.
Education and Experience
Education:
Bachelor's degree in science or life sciences discipline, or equivalent experience in the life science field.
6+ years of experience in the pharmaceutical/drug development/biotechnology industry experience including work on products in Ph3 execution and commercialization planning.
PMP certification is strongly preferred.
Experience:
5+ years of project management experience leading multiple projects concurrently, several functions, and across different stages of development.
5+ years of experience in financial management, including budget management and tracking, forecasting, and resource allocation.
Proficient in at least two key drug development functions, such as clinical operations, manufacturing development, regulatory affairs, or non-clinical development.
Demonstrated experience in managing and coordinating multiple tasks and functional areas within complex projects.
Skills and Competencies
Proven track record working in cross-functional teams, with the ability to both support and influence the strategic direction of drug development initiatives.
Advanced knowledge of project scheduling software and tools, with SmartSheet experience preferred.
Ability to ensure alignment between project execution and overarching business strategies.
Key Capabilities
Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
Continuous learning: Show a commitment to ongoing learning
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Amer Sports may also be known as or be related to Amer Sports and Amer Sports Company.