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Optimas Solutions

<div><div>Business Development Director</div><div>
Maltepe / Istanbul</div><div>
</div><div>
About Optimas:</div><div>
</div><div>
Optimas is a global distributor of integrated supply chain solutions, and engineering support focused on delivering fasteners, components, industrial and safety supplies to our diverse customers around the world. Our local, on-the-ground teams understand the nuances of every community we serve. This allows us to adapt with our customers and partners as needs evolve, leveraging our footprint to remain at your side while providing a highly personalized level of service and support no matter where you find yourself around the globe.</div><div>
To learn more, please visit our website http://www.optimas.com/</div><div>
</div><div>
 Position overview:</div><div>
</div><div>
Optimas is looking for a self-starter, dynamic and determined Business Development Director who will be responsible of developing the market in the region according to the company&rsquo;s business strategies. This position will also develop potential key accounts to achieve target business growth, according to company&rsquo;s business strategies.</div><div>
</div><div>
This position requires up to 50% travel, reports directly to the General Manager - Turkey, and plays a key role in contributing to the success of the entire organization. If you are a committed professional and a fearless learner who thrives in a dynamic and challenging environment, we encourage you to join us!</div><div>
</div><div>
Main responsibilities:</div><ul><li>
Develop potential key accounts to achieve target business plans,</li><li>
Promote and sell Optimas&rsquo; total value proposition (products, engineering &amp; logistics),</li><li>
Build good strategic relationships with all related functions internally and externally for projects realization and acceleration,</li><li>
Develop existing &amp; new customers to their full potential,</li><li>
Be aware of market changes and competitors&rsquo; activities and report periodically,</li><li>
Make sales presentations and solicit RFQs in time,</li><li>
Work closely with the global Program Manager/Architect,</li><li>
Contract review and signing and E&amp;O discussion &amp; resolutions periodically,</li><li>
Present sales/key customer report monthly,</li><li>
Create and realize business development plan and sales/market forecast,</li><li>
Analyze business performance of key accounts and formulate strategies and action plans to improve GP and profitability,</li><li>
Assure overall customer satisfactions,</li><li>
Other responsibilities assigned by superiors.</li></ul><div>
Skills and Qualifications:</div><div>
</div><div>
The ideal candidate must have the following competencies:</div><ul><li>
B.S. in Industrial Engineering, Mechanical Engineering or any other relevant academic background,</li><li>
Over 5 years of relevant working experience,</li><li>
Experience in the fastener or C class components industry and in a multinational company is preferred,</li><li>
Excellent English communication skills &ndash; written and spoken [Must],</li><li>
Experience in project management and reporting in complex multidisciplinary projects,</li><li>
Project management skills and experience in implementing projects within decentralized organizations,</li><li>
Have high degree of integrity, ethics, motivation, energy and enthusiasm,</li><li>
Strong interpersonal skills, communication and negotiation skills,</li><li>
Strong analytical and problem solving skills.</li></ul><div>
</div><div>
Optimas is strongly committed to creating and preserving equal opportunities for all employees and applicants. Optimas makes all employment decisions &ndash; including recruitment, hiring, compensation, training, promotion, transfer, discipline, termination, and other personnel matters &ndash; based on merit, and without regard to race, color, ancestry, religion, sex, national origin, age, disability, genetic information, veteran status, marital status, sexual orientation, or other legally protected characteristics or conduct. Optimas&rsquo; strong commitment to equal opportunity requires commitment by each individual employee. Compliance with the letter and spirit of this policy is required by all employees. Violations of this policy should be immediately reported to your Supervisor, Human Resources or the Legal Department.</div></div>

Business Development Director

<div>
 
 
 Aon is in the business of better decisions
 
 
 
 At Aon, we shape decisions for the better to protect and enrich the lives of people around the world.
 
 
 As an organization, we are united through trust as one inclusive, diverse team, and we are passionate about helping our colleagues and clients succeed.
 
 
 Aon provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status. Aon is committed to a diverse workforce and is an affirmative action employer.
 
 
 
 
 
 
 We are looking for a Business Development Associate Director for our Growth Strategies and Marketing Department.
 
 
 
 
 
 
 
 Skills And Experience That Will Lead To Success
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Business, Economics or relevant field,
 </li>
 <li>
 Proven experience in insurance market,
 </li>
 <li>
 good command of English both written and spoken is an asset,
 </li>
 <li>
 Efficiently work under pressure and deadlines to complete assigned task,
 </li>
 <li>
 Ability to work independently and as part of a team in a fast-paced and dynamic environment,
 </li>
 <li>
 Problem solving skills, goal orientation and proactivity,
 </li>
 <li>
 Above-average negotiation skills,
 </li>
 <li>
 Driving license B.
 </li>
 </ul>
 
 
 
 
 
 Job Description
 
 
 <ul>
 <li>
 Creating strategies to successfully reach new business opportunities
 </li>
 <li>
 Building relationships with new clients, understanding their needs and developing quotes to address these needs
 </li>
 <li>
 Attending conferences and events to build relationships with industry partners and stayind up to date with new trends
 </li>
 <li>
 Creating sales forecasts and actively working towards reaching them
 </li>
 <li>
 Preparation of commercial presentations and management and updating of the contact database.
 </li>
 <li>
 Possessing a strong understanding of the company&rsquo;s products, the competition in the industry and positioning
 </li>
 </ul>
 
 
 
 
 
 How We Support Our Colleagues
 
 
 
 In addition to our comprehensive benefits package, we encourage a diverse workforce. Plus, our agile, inclusive environment allows you to manage your wellbeing and work/life balance, ensuring you can be your best self at Aon.
 
 
 Furthermore, all colleagues enjoy two &ldquo;Global Wellbeing Days&rdquo; each year, encouraging you to take time to focus on yourself.
 
 
 We offer a variety of working style solutions, but we also recognise that flexibility goes beyond just the place of work... and we are all for it. We call this Smart Working!
 
 
 Our continuous learning culture encourages and equips you to learn, share and grow, helping you achieve your fullest potential. As a result, at Aon, you are more connected, more relevant, and more valued.
 
 
 
 
 
 
 
 
 
 #LI-BY1
 
 
 
 2565584
 
</div>

Business Development Associate Director

Aksa Power Generation

<div>
 
 
 ABOUT AKSA POWER GENERATION
 
 
 
 Aksa Power Generation is one of the most valuable manufacturers of power generation systems in the world, which is a subsidiary of Kazanci Holding.
 
 
 
 
 
 AKSA is operating in manufacturing, technology development, marketing, and distribution fields in power generation and energy systems. Selling to 178 countries, the range of the company includes diesel generators, portable generators, marine generators, natural gas generators, control panels, soundproofed canopies, and lighting towers. The production zones are located in Turkiye, in China (the world&rsquo;s largest power generator plant), in the USA, and in Spain (with the Dagartech trademark), also have a trade and assembly center in the Netherlands to serve our European clients.
 
 
 
 
 
 
 ABOUT THE POSITION
 
 
 
 AKSA Power Generation is looking for an
 
 International Sales Director
 
 who has strong experience in that process for our
 
 Kavacik HQ Office
 
 to be responsible for the HQ Office Export Sales Team and our some overseas operations.
 
 
 
 
 
 
 WHAT MUST YOU HAVE (GENERAL QUALIFICATIONS)
 
 
 <ul>
 <li>
 Resident in Istanbul with no obstacle to work at our Kavacik HQ Office.
 </li>
 <li>
 University degree in Engineering Faculties will be a priority
 </li>
 <li>
 Be able to have a minimum of 20 years of experience in total business life
 </li>
 <li>
 Min 10 years of last experience in similar positions
 </li>
 <li>
 Experience in production companies is a plus.
 </li>
 <li>
 Excellent command of written and spoken English,
 </li>
 <li>
 Second foreign language is a plus (Chinese, Spanish, or French languages are preferable)
 </li>
 <li>
 Strong analytical approach and leadership qualifications
 </li>
 <li>
 Be able to do international travels more than once a month,
 </li>
 <li>
 Excellent communication and reporting skills,
 </li>
 <li>
 No military obligation for male candidates.
 </li>
 </ul>
 
 
 
 
 
 WHAT WILL YOU DO (JOB DESCRIPTIONS)
 
 
 <ul>
 <li>
 Responsible for managing the export sales team based at Kavacik HQ Office and the consolidation of sales teams located at our international offices and representations.
 </li>
 <li>
 To collect and analyze information about the market and potential customers to guide business development.
 </li>
 <li>
 Be able to prepare annual sales budgets for assigned product groups and manage the team in line with company targets.
 </li>
 <li>
 To develop sales strategies to increase profitability and ensure sustainable growth.
 </li>
 <li>
 Managing activities to expand the customer portfolio and strengthen relationships with existing clients.
 </li>
 <li>
 To conduct market research and competitor analysis to support entry into new country markets with the right products and strategies.
 </li>
 <li>
 To follow up and report market data, profitability, and industry trends to management.
 </li>
 <li>
 To improve the performance and efficiency of all teams and offices under responsibility.
 </li>
 <li>
 Be able to ensure effective communication and coordination between international offices and HQ.
 </li>
 <li>
 Leading the team with clear business plans and projects to achieve global sales targets.
 </li>
 <li>
 Tracking monthly performance to ensure annual goals are met.
 </li>
 <li>
 To participate in international fairs and business trips to build new customer networks and follow the competition.
 </li>
 <li>
 Developing new sales strategies and campaigns based on market needs and opportunities.
 </li>
 <li>
 Supporting the professional growth of team members through coaching and training.
 </li>
 </ul>
</div>

International Sales Director

Monster Energy

<div>
 
 
 About Monster Energy:
 
 
 
 Forget about blending in. That's not our style. We're the risk-takers, the trailblazers, the game-changers. We're not perfect, and we don't pretend to be. We're raw, unfiltered, and a bit unconventional. But our drive is unrivaled, just like our athletes. The power is in your hands to define what success looks like and where you want to take your career. It's not just about what we do, but about who we become along the way. We are much more than a brand here. We are a way of life, a mindset. Join us.
 
 
 
 
 
 
 A day in the life:
 
 
 
 As the Region Director, you'll take the reins on the region's Profit and Loss (P&amp;L) with a dynamic strategy and powerhouse execution. Dive into business planning, crafting and powering up the implementation process. Team up and rock it out with the General Managers of our Distribution Partners (DP) for maximum impact and success!
 
 
 
 
 
 
 The impact you'll make:
 
 
 <ul>
 <li>
 Identify market opportunities and insights to drive continuous growth. Design and support the communication of commercial calendar via identified business opportunities. Develop specific, measurable, actionable priorities, targets, and programs, tailoring company strategy and direction to the local realities, together with the local internal and distribution partner teams. Design and support the execution related initiatives in order to ensure reaching company volume, profit, growth targets. Build market, channel strategy and support the execution of commercial initiatives for profitable market, channel growth.
 </li>
 <li>
 Partner with the teams and the distribution partner's leaders to design and align success in all key channels; design and plan the most outstanding in-store activation programs, partnering with marketing and trade marketing teams to sell the brand proposition, leveraging the best international and local properties.
 </li>
 <li>
 Align volume goals (market, channel, mix, phasing) and key elements of the country P&amp;L and manage accuracy of the forecasted of volume and spend. Develop the right value chains with the distribution partners, and have the right list price by channel to reach the agreed shelf pricing strategy and offer the adequate margin to the different customers, wholesaler. Align internally the other elements of the P&amp;L and help local team to track internally and DP finance teams that spend are in line with budget. Budget the right trade spending to ensure maximal distribution and presence of the brand (line-up, listing, slotting) and promotional investments to achieve the agreed promotional strategy and maximize the number of displays/secondary placements.
 </li>
 <li>
 Build brand roll out planning through designing, planning and aligning regarding all cross functional aspects and KPIs. Work closely with internal departments on short to medium term demand planning (Month, Quarter) and work with marketing and DP on long term forecasting.
 </li>
 <li>
 Define Revenue Management strategy in Business Planning period and work with commercial and finance planning team. Prepare action plans for mix management by size and channel and selling stories to explain the reason for price transitions, design commercial arguments for retailer margin movements.
 </li>
 <li>
 Set channel strategies and execution standards in order to support capturing incremental volume and profit for each market and channel. Analyze sales performance against annual targets and review effectiveness, implementation of the different agreed programs and activities.
 </li>
 <li>
 Master Nielsen reports and databases to understand category, brand, SKUs, channels and competitor performances and make relevant recommendations. Define the right promotional plans (discount, pricing, frequency) to secure the right number of displays, grow sales while maintaining profitability.
 </li>
 <li>
 Review and analyze sales to distribution partners, customers and consumers to identify trends, drivers, risks and opportunities. Understand DP sales information (e.g. SAP) to monitor their performance with customers or coverage of their sales force. Monitor and track sales to DP and inventories to communicate solid forecast and make recommendation to further accelerate sales.
 </li>
 <li>
 Actively support the co-ordination, setting up of timelines and deliverables to the region and individual countries. Able to take decision and operate as the vital link across all necessary departments both internally and DPs to ensure that all necessary tasks are completed, and objectives are achieved.
 </li>
 </ul>
 
 
 
 
 
 Who you are:
 
 
 <ul>
 <li>
 Prefer a Bachelor's Degree in the field of Business Administration, Sales, Marketing, Finance or related field of study.
 </li>
 <li>
 Additional Experience Desired: More than 20 years of experience in Sales, Marketing in beverage or CPG (Consumer Packed Goods)
 </li>
 <li>
 Additional Experience Desired: More than 20 years of experience in New Product Development management.
 </li>
 <li>
 Computer Skills Desired: Advanced user Microsoft Office
 </li>
 <li>
 Additional Knowledge or Skills to be Successful in this role: English proficiency is preferred.
 </li>
 </ul>
 
 
 
 
 
 * Please submit your application with an English resume for faster processing.
 
 
</div>

Region Director

Hitachi Energy

<div>Description
The opportunity
We are seeking a results-driven Global Business Development Lead to drive growth across key sales dimensions&mdash;accounts, channels, geographies, and segments. This role will be instrumental in balancing demand and supply globally by ensuring transparent allocation processes, enhancing pipeline execution, and developing agile sourcing strategies in collaboration with regional Hubs. The ideal candidate will combine strong analytical capabilities with cross-functional leadership to support our global business ambitions. This role will be reporting directly to the Global Product Group &ndash; Distribution and Traction Transformers Manager and functionally to the Business Unit Head of Marketing &amp; Sales -BU Transformers
How you&rsquo;ll make an impact<ul><li>
Drive sales acceleration across the 4D of sales: accounts, channels, geographies, and segments.</li><li>
Define and implement structured follow-up plans with Hubs using SFDC monitoring for large opportunities.</li></ul><ul><li>
Proactively drive allocation discussions to ensure early alignment and be flexible to revisit and revise allocation rules as needed to reflect evolving business needs.</li><li>
Ensure allocation rules are clearly communicated and understood by all stakeholders.</li><li>
Develop and deploy a Power BI tool based on the allocation file, including lead time visibility to support the bidding team globally.</li></ul><ul><li>
Monitor and follow up on GAM/KAM/channel/market pipeline development.</li><li>
Ensure execution aligns with GTS targets, budget expectations, and strategic ambitions.</li></ul><ul><li>
Collaborate with Hubs to develop flexible and transparent sourcing strategies.</li><li>
Lead strategic capacity planning across Hubs for key customers (e.g., DtC hyperscalers, large DSOs, OEMs).</li></ul><ul><li>
Identify and develop opportunities in target segments and white spots anddrive business development performance in these target segments.</li><li>
Support strategic growth initiatives and market expansion efforts.</li></ul><ul><li>
Ability to foster trust, transparency and collaboration across the organization.</li><li>
Ability to perform effectively under pressure, maintaining focus and delivering results in fast-paced environment.</li><li>
Strong conflict management skills, with a constructive and solution-oriented approach to resolving interpersonal or organizational tensions.</li><li>
Quick and confident decision-making, especially in time-sensitive or high-impact situations.</li><li>
Demonstrating adaptability, emotional intelligence, and a proactive mindset when facing challenges or resistance.</li></ul>
Your background<ul><li>
Degree in Engineering or Business Administration</li><li>
15 + years of experience in product marketing and sales, ideally within the relevant product portfolio</li><li>
Proven track record in strategic leadership roles within international corporate environments</li><li>
Strong experience in global business, including cross-cultural, legal, and contractual aspects</li><li>
Deep understanding of the marketplace, demand and supply dynamics, and customer needs</li><li>
Line management experience</li><li>
Ability to coordinate and leverage corporate resources effectively</li><li>
Excellent leadership, communication, and stakeholder management skills with intercultural sensitivity</li><li>
Customer-focused, results-driven, and experienced in driving profitable growth</li><li>
Fluent in English; additional languages are an advantage</li></ul><h2 class="jobSectionHeader">
Qualified individuals with a disability may request a reasonable accommodation if you are unable or limited in your ability to use or access the Hitachi Energy career site as a result of your disability. You may request reasonable accommodations by completing a general inquiry form on our website. Please include your contact information and specific details about your required accommodation to support you during the job application process.</h2><h2 class="jobSectionHeader">
This is solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.</h2></div>

Global Business Development Lead GPG DT

IQVIA

<div>Job Overview
The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs.
The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:
Essential Functions
Functions as project team member:
<ul><li>Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
</li><li>Ensures medical activities run according to GCP and operate with highest efficiency.
</li><li>Establishes and maintains a network of medical/scientific consultants, etc.
</li><li>Supervises and manages Medical Director activities.
</li></ul>Clinical Activities:
<ul><li>Interacts with clients regarding drug development programs, study design and protocol.
</li><li>Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
</li><li>Interacts in team approach to develop statistical and data management sections of the protocol.
</li><li>Reviews the final protocol for clinical, safety and efficacy variables.
</li><li>Provides project team training on protocol and/or therapeutic areas.
</li><li>Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
</li><li>Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations.
</li><li>Presents protocol and/or safety reporting information at investigator meetings.
</li><li>Develops project medical monitoring plans as requested.
</li><li>Provides on call coverage for protocol queries and site support.
</li><li>Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
</li></ul>Safety Monitoring and SAE Reporting Activities:
<ul><li>Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
</li><li>Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
</li><li>Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data.
</li><li>In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).
</li><li>Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
</li></ul>Data Activities:
<ul><li>Provides medical review of eCRFs for clinical accuracy.
</li><li>Provides medical review of data analysis plan.
</li><li>Reviews safety fields at case freeze for reconciliation (if needed).
</li><li>Works with data group to reconcile SAE events as needed.
</li><li>Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
</li><li>Reviews data tables, listings, and figures.
</li><li>Reviews and/or writes portions of final clinical study report.
</li></ul>DSMB/Adjudication Committee Activities:
<ul><li>May assist sponsor in choosing committee members.
</li><li>May serve as a non-voting member to convene and organize proceedings.
</li><li>May develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
</li><li>May determine data flow with sponsor to ensure reporting accuracy.
</li><li>Can ensure DSMB feedback is given to sites for IRBs.
</li><li>All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor.
</li></ul>Business Development Activities:
<ul><li>Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development.
</li><li>Supports business development activities with proposal development and sales presentations.
</li><li>Participates in feasibility discussions relating to specific project proposals.
</li></ul>Special Projects:
<ul><li>Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
</li><li>Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities.
</li><li>Participate in a variety of team quality improvement efforts as necessary.
</li><li>Perform other related duties as assigned or requested by the Chief Medical Officer.
</li></ul>Qualifications
<ul><li>Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
</li><li>10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development.
</li><li>3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience.
</li><li>Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
</li><li>Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
</li><li>Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
</li><li>Excellent oral and written communications skills as well as interpersonal skills are essential.
</li></ul>Oncology / Hematology
<ul><li>Current or prior license to practice medicine; board certification/eligibility ideal (Preference)
</li><li>Board Certified / Board Eligible: Oncology (Required)
</li></ul>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</div>

Medical Director - Oncology , Home- Based

<div>Job Overview
The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs.
The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:
Essential Functions
Functions as project team member:
<ul><li>Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
</li><li>Ensures medical activities run according to GCP and operate with highest efficiency.
</li><li>Establishes and maintains a network of medical/scientific consultants, etc.
</li><li>Supervises and manages Medical Director activities.
</li></ul>Clinical Activities:
<ul><li>Interacts with clients regarding drug development programs, study design and protocol.
</li><li>Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
</li><li>Interacts in team approach to develop statistical and data management sections of the protocol.
</li><li>Reviews the final protocol for clinical, safety and efficacy variables.
</li><li>Provides project team training on protocol and/or therapeutic areas.
</li><li>Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
</li><li>Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations.
</li><li>Presents protocol and/or safety reporting information at investigator meetings.
</li><li>Develops project medical monitoring plans as requested.
</li><li>Assist the team and sites in responding to protocol-related or study-related or medical questions.
</li><li>Assist site staff with urgent and non-urgent safety events, and provide recommendations in accordance with the protocol.
</li><li>Provides on call coverage for protocol queries and site support.
</li><li>Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
</li></ul>Safety Monitoring and SAE Reporting Activities:
<ul><li>Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
</li><li>Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
</li><li>Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data.
</li><li>In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).
</li><li>Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
</li></ul>Data Activities:
<ul><li>Provides medical review of eCRFs for clinical accuracy.
</li><li>Provides medical review of data analysis plan.
</li><li>Reviews safety fields at case freeze for reconciliation (if needed).
</li><li>Works with data group to reconcile SAE events as needed.
</li><li>Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
</li><li>Reviews data tables, listings, and figures.
</li><li>Reviews and/or writes portions of final clinical study report.
</li></ul>DSMB/Adjudication Committee Activities:
<ul><li>May assist sponsor in choosing committee members.
</li><li>May serve as a non-voting member to convene and organize proceedings.
</li><li>May develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
</li><li>May determine data flow with sponsor to ensure reporting accuracy.
</li><li>Can ensure DSMB feedback is given to sites for IRBs.
</li><li>All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor.
</li></ul>Business Development Activities:
<ul><li>Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development.
</li><li>Supports business development activities with proposal development and sales presentations.
</li><li>Participates in feasibility discussions relating to specific project proposals.
</li></ul>Special Projects:
<ul><li>Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
</li><li>Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities.
</li><li>Participate in a variety of team quality improvement efforts as necessary.
</li><li>Perform other related duties as assigned or requested by the Chief Medical Officer.
</li></ul>Qualifications
<ul><li>Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
</li><li>10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development.
</li><li>3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience.
</li><li>Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
</li><li>Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
</li><li>Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
</li><li>Excellent oral and written communications skills as well as interpersonal skills are essential.
</li></ul>Oncology / Hematology
<ul><li>Current or prior license to practice medicine; board certification/eligibility ideal (Preference)
</li><li>Board Certified / Board Eligible: Hematology (Required)
</li><li><h2 class="jobSectionHeader">Applicants must have experience in at least one of the following areas: Hematology (Non-Malignant) , Hematological Malignancies , Pediatric Hematology / Adult Hematology
</h2></li></ul>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</div>

Medical Director - Hematology , Home- Based

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