Careers at Loxo

About Loxo Oncology: Loxo Oncology is dedicated to developing highly selective medicines for patients with genetically defined cancers. We base our approach on two scientific trends: the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.

Some people develop cancers that are caused by a single inappropriate DNA change, known as “oncogenic drivers.” When a genetic test identifies a patient with an oncogenic driver, there should be a personalized medicine to address this error in the DNA that is leading to the cancer. At Loxo Oncology, we are developing a pipeline of highly selective drugs that inhibit oncogenic drivers in cancer.

/Loxô/ is a term from Greek mythology that refers to the trajectory of an arrow, a fitting metaphor for our approach to developing precise, targeted therapies against genetically defined cancers.

Accounts Payable Coordinator, Temporary

Location:

Stamford, CT

Reports To:

AP Analyst

Position Summary

Based in Stamford, CT, the Accounts Payable (AP) Coordinator position is full-time, temporary role that reports to the AP Supervisor. This position will ensure that invoices, purchase orders, payments, and other company expenses are processed accurately and timely, and that excellent relationships are maintained with our vendors and functional internal leads. This individual must possess great attention to detail, meticulous organization skills, and a strong desire and ability to work within a dynamic, fast-paced environment with the expectations of the role consistently growing and expanding.

Roles and Responsibilities of the Position*

Responsible for reviewing and transferring invoices from invoice mailbox to cloud storage.
Record invoices and credits into AP system module.
Compares incoming invoicing against contracts and purchase orders to ensure accuracy.
Respond to rush requests with a sense of urgency as needed.
Reviews invoice calculations, timesheets, expenses, sales tax etc.
Ensures payments are made in a timely fashion.
Identify and document non-compliant invoices.
Resolve invoice discrepancies directly with vendors and maintaining good vendor relations.
Provide general ledger account coding for all invoices.
Assist with 1099 process and vendor maintenance.
Distribute invoices to approvers for payment authorization.
Assist with current AP workflow and provide input to ensure process is increasingly efficient.
Vendor maintenance support including adding and updating information and cleaning of data.
Ensure W9 or W8BEN for is received for all vendors.
Prepare weekly domestic international wires.
Process weekly payment cycle.
Maintain excellent communication and relationships with key stakeholders.
Assist with quarterly accruals.
Follow SOX internal controls and established processes.
Ad hoc reporting and related projects, as requested.

Required Qualifications and Background

5+ years in accounts payable or relevant finance experience within a SOX controlled environment.
Biotech, startup, or pharmaceutical experience a plus.
Experience with any SaaS (cloud based) accounting systems a plus.
Degree in accounting a plus.
Experience and ability to work in fast-paced environment.
Excellent interpersonal and communication skills (written and oral).
Strong organizational skills with amazing attention to detail.
Strong IT acumen with ability to work across multiple platforms and paperless AP environments.

Physical Demands / Travel

The physical demands of this position are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Administrative Assistant, Contractor

Location:

South San Francisco, CA

Reports To:

Executive Assistant

Position Summary

This position provides administrative and secretarial/receptionist support for the South San Francisco office, the Executive Assistant and staff. In addition to typing, filing and scheduling this position performs duties such as coordination of meetings and conferences, obtaining supplies, coordinating direct mailings and working on special projects. Other duties include answering non-routine correspondence and assembling highly confidential and sensitive information. This position interacts with a diverse group of important external callers and visitors as well as internal contacts at all levels of the organization. Independent judgment is required to plan, prioritize and organize a diversified workload and recommend improvements in office practices or procedures.

Roles and Responsibilities of the Position*

Must be able to work from 8:30am-5pm Mondays through Fridays.
Schedules and organizes complex activities such as meetings, travel, conferences and department activities.
Acts as receptionist for company and greets outside visitors as needed.
Establishes, develops, maintains and updates filing system for the Vice President and the department. Retrieves information from files when needed. Establishes, develops, maintains and updates library of trade journals and magazines.
Organizes and prioritizes large volumes of information and calls.
Sorts and distributes mail. Drafts written responses or replies by phone or e-mail when necessary. Responds to regularly occurring requests for information.
Answers phones as needed. Takes messages or fields/answers all routine and non-routine questions. Works in cooperation with other assistants to cover phones.
Works both independently and within a team on a range of ongoing and on-off special projects. Acts as project manager for special projects, as needed, which may include: planning and coordinating multiple presentations and disseminating information.

Required Qualifications and Background

B.A. degree preferred with at least 3+ years of administrative support in smaller companies.
Professional demeanor and appearance and an excellent written and verbal communicator.
Detail oriented and well organized.
Able to work within a fast-paced environment adept at juggling multiple tasks and priorities.
Good and thoughtful listener.
Willing collaborator.
Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this position are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

Apply Now

Associate Director, Chemical Manufacturing Controls

Location:

Boulder, CO

Reports To:

Senior Director CMC

Position Summary

The Associate Director, Chemical Manufacturing Controls (CMC) is responsible for leading and coordinating research and manufacturing operations at contract manufacturing organization (CMOs). The incumbent is responsible for ensuring that current GMP standards are implemented for the production and the control of manufactured drug substance and/or drug products.

Roles and Responsibilities of the Position*

Manage day to day activities at drug substance and/or drug product CMOs. Directly interacts with contract site management (may include being on site at CMO).
Proactively manages risks/capability and develops mitigation plans. Identifies and communicates risks and issues that impact quality, compliance, project timelines, resource requirements, finance or the overall business relationship.
Prepares RFPs and tech packages for the procurement of starting materials and GMP drug substance and drug product manufacturing campaigns.
Reviews and approves, as required, CMO documentation, including:
- Analytical process development and stability protocols, methods and reports.
- Technical review of CMO change documentation.
- Technical review of draft and executed drug substance and drug product batch records.
Works with QA to prepare drug substance and drug product specifications and assists in the design of drug substance and drug product stability studies.
Writes and reviews CMC sections of regulatory documentation.
Participates in audits of current and potential CMOs as technical CMC representative.
Assists contract discovery organizations with technical support.

Required Qualifications and Background

Proven experience in execution/management of GMP manufacturing activities.
Prior CMC/manufacturing experience/responsibilities including management of Contract Manufacturing Organization.
MS or Ph.D. degree in Organic Chemistry with 10+ years of related experience in the pharmaceutical sector.
Proficiency in MSOffice, Outlook and database applications, including knowledge of various desktop applications.
Strong oral and written skills with proficiency in English.
Excellent organizational skills.
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Ability to multi-task effectively and prioritize assignments from multiple sources.

Physical Demands / Travel

This position’s physical demands are consistent with working within a lab setting; some light lifting may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

Must be able to work with chemicals in lab setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each of the responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

Clinical Research Associate

Department:

Clinical Operations

Location:

Stamford, CT

Reports To:

Associate Director or Director, Clinical Operations

Position Summary

The Clinical Research Associate, in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

Roles and Responsibilities of the Position*

Project Management:

Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
Use performance metrics and quality indicators to assist the Clinical Trial Manager in driving study execution.
Participate in monitoring visit report review process to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
Support Health Authority inspections and CQA audits as required.
Ensure full compliance (completeness and accuracy) of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
Provide proactive identification of potential risks and develop and implement actions to avoid or mitigate.
Develop and maintain collaborative relationships with internal and external partners/stakeholders.

Study Planning and Conduct:

Collaborate with vendors and Loxo CTM’s regarding study specific issues and follow through to resolution.
Assist in the creation and review of study documents, including but not limited to the Protocol, Protocol Synopsis, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.
Participate in vendor specification development and management/oversight.
Assist with management of TMF set-up, ongoing quality review, and final reconciliation.
Assist with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
Actively contribute to study meetings including presenting as a subject matter expert, generating, finalizing and distributing study team agendas and recording meeting minutes as needed.
Contribute to development/coordination of study training and study training materials for study team, investigational sites, and vendors.
Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Assist with investigator meeting coordination and planning.

Required Qualifications and Background

Degree in a relevant discipline with experience in the Clinical Trial environment required.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Ability to multi-task effectively and prioritize assignments from multiple sources.
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments.
Knowledge of study tools including electronic system skills such as CTMS / EDC/ IRT/eTMF.
Knowledge of drug development process.
Proactively shares information, ideas, input, and/or expertise with team members.
Demonstrates concern for high quality outcomes.
Responds flexibly to changing business demands and opportunities, proactively looks for ways to contribute.
Basic understanding of project management desired.
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
Strong oral and written skills with proficiency in English.
Excellent organizational skills

Physical Demands / Travel

This position may require up to 25% travel. Some of the travel may be international.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in the field and in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

Apply Now

Clinical Scientist

Location:

Stamford, CT, South San Francisco, CA

Reports To:

Senior Director, Clinical Development & Medical Affairs

Position Summary

This position offers the opportunity to participate in the entire spectrum of the drug development process. Loxo designs drugs “from the ground up” by selecting a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. This role is integral in moving this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. The Clinical Scientist will participate directly in improving the lives of people fighting their cancers.

Roles and Responsibilities of the Position*

In tandem with the Medical Director this role designs, implements and executes Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as the position interacts with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

Loxo is a small company highly focused on clinical and regulatory execution. As a key member of the team, the Clinical Scientist will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This individual must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.

Required Qualifications and Background

PhD, PharmD or M.D.
The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years medical/clinical scientist experience in oncology. At least 5 years clinical research experience preferred, particularly in drug development in oncology.
Clinical trial expertise with experience in oncology with drug development highly desirable.
Must possess a strong background in clinical trials in an academic or industry setting.
Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
Travel up to 20%, may include international travel

In summary, qualities sought include: intrinsic motivation, excellent communication and organizational skills; a passion for biomedicine and for patients; broad prior experience in drug development; and a comfort and desire to learn new skills.

Physical Demands / Travel

This position requires approximately 20% travel, which will fluctuate as business imperatives change.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in the field, occasionally in a lab and within a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

Apply Now

Clinical Trial Manager

Department:

Clinical Operations and Project Management

Location:

Stamford, CT or South San Francisco, CA

Reports To:

Director Clinical Operations

Position Summary

The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

Roles and Responsibilities of the Position*

Required Qualifications and Background

BA/BS in related field.
Minimum 8 years clinical drug development experience.
Experience in personnel management.
Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
Experience in managing oncology clinical trials (international preferred).
Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
Ability to work within a team, including leadership skills.
Ability to organize and prioritize multiple tasks.
Excellent communication and interpersonal skills.
Attention to detail, organization, and problem-solving skills.
Proficient in MS Office.

Physical Demands / Travel

This position requires approximately 25% domestic and international travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical field and office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

Apply Now

Director / Senior Director, Commercial Operations

Location:

Stamford, CT

Reports To:

Executive Director, Commercial

Position Summary

Reporting to the Executive Director, Commercial, The Director / Senior Director, Commercial Operations will build a best-in-class biotech operations department to support the launch of several exciting new oncology drugs. The Director / Senior Director will be responsible for a wide variety of projects across the commercial and medical organizations to include functioning as the business lead for operational implementation of field facing systems and incentive compensation.

Roles and Responsibilities of the Position*

Required Qualifications and Background

Bachelor’s Degree in Business/Marketing, Accounting, Computer Science or related field—MBA preferred.
Minimum of seven years of biotech/pharmaceutical operations management experience, including sales operations.
Experience hiring high-performing operations team members and establishing the infrastructure needed to ensure readiness for a first commercial drug launch.
Strong knowledge of pharmaceutical sales data and systems including Veeva CRM.
Experience with the launch of new sales organizations and products and the development and implementation of field force deployment strategies.
Extensive experience with the development and implementation of national incentive compensation plans.
Skilled at communicating complex concepts to senior leaders/field colleagues.
Strong analytical skills with the capability to appropriately define issues, questions and data needs.
Experience managing third-party providers.
Demonstrated skills in interdependent team leadership. Highly developed decision-making and leadership skills.
Proven ability to direct multiple projects effectively.
Proficient with Microsoft Office.

Physical Demands / Travel

This role requires approximately 20% travel. Otherwise the demands of this role are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in the field and in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

Apply Now

Director, Commercial Analytics

Location:

Stamford, CT

Reports To:

Executive Director, Commercial

Position Summary

Reporting to the Executive Director, Commercial, the Director, Commercial Analytics will build a best-in-class biotech data management, analytics, and forecasting function to support the launch of several exciting new oncology drugs. The Director will work across key commercial functions to acquire, integrate, and manage data and to deliver analytical support and KPI reporting to help guide business decisions and support go-to market strategies.

Roles and Responsibilities of the Position*

These may include, but are not limited to:

Required Qualifications and Background

BA/BS required with a minimum of 7+ years of pharmaceutical/biotech experience in increasing roles of responsibility; advanced degree highly desirable.
Extensive knowledge of and experience in commercial analytics (including forecasting and sales analytics) and master data management is required.
Experience in oncology and/or rare disease required; experience managing and analyzing specialty pharmacy data feeds required.
Must have experience executing pharmaceutical incentive compensation programs.
Experience managing primary market research plans, projects, and vendors preferred.
Previous experience supporting marketing, sales, medical affairs and strategic planning functions.
Proven experience evaluating and selecting secondary data and market research vendors, as well as business intelligence tools required.
Ability to convert analytical findings to market insights so that they are clear and concise to any audience is necessary.
Strong spreadsheet/database analytical skills and advanced Excel and PowerPoint required.
Ability to lead and mobilize cross-functional working groups and project teams.
Excellent analytical, writing and presentation skills are essential.
Ability to prioritize and oversee multiple projects in a fast-paced, fluid environment.
Must be highly organized, detail-oriented and results-driven.
Must be proficient in Microsoft Office suite.

Physical Demands / Travel

Ability to travel domestically and internationally as the position requires.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in the field and in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

Apply Now

Director, National Accounts

Location:

Stamford, CT or Remote

Reports To:

Executive Director, Market Access

Position Summary

The Director, National Accounts, reporting to the Executive Director, Market Access, will be responsible for developing relationships with leading national, regional, and local payers as well as channel decision-makers. This individual will develop and manage their accounts to attain key objectives for the Loxo Oncology product portfolio. The Director, National Accounts will implement short and long-term strategic initiatives to ensure appropriate coverage, coding, and payment within their managed market accounts.

Roles and Responsibilities of the Position*

Required Qualifications and Background

A minimum of 5 years’ experience managing national and major regional payer accounts (Commercial, Medicare, and Medicaid) and leading successful contract negotiations.
Experience in managing key customers in the Managed Care, Oncology GPO and Specialty arena. Must have account relationships established.
Oncology or specialty care pharmaceutical product experience is required.
Bachelor’s degree is preferred and/or equivalent work experience.
Sales or sales management experience highly desirable.
Demonstrated knowledge of payer decision-making for policy, coverage, coding and patient access to existing and new products.
Ability to create and present strategic business plan to senior level managers both internally and to customers.
Strong management, organizational, communication, negotiation, and business development skills.
Demonstrated ability to manage budget and resources.
Team player who can successfully collaborate with other account team members and across all commercial and field team members.
Demonstrated effectiveness operating in a field-based position with proven ability to work independently, adhere to specific timelines, deliver on administrative responsibilities, and execute business planning and initiatives.
Knowledge and ability to perform all company business in accordance with all regulations (e.g. EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc) and company policies and procedures. Report noted/observed violations immediately to management. Demonstrate high ethical and professional standards with all business contacts to maintain the company’s excellent reputation within the medical and pharmaceutical community.
Proficiency in MSOffice, Outlook and database applications, including knowledge of various desktop applications.
Experience in Cognos/Report writing toolset required.

Physical Demands / Travel

This position requires up to 70% travel (50-60% field, 5-10% corporate office based).

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in the field and in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

Apply Now

Head of Compliance

Location:

Stamford, CT

Reports To:

CEO

Position Summary

Loxo Oncology is seeking to establish a world-class compliance program. We seek an individual to help build and establish the corporate compliance function to enhance the company’s strong culture of compliance. Reporting directly to the Chief Executive Officer, the Head of Compliance will work collaboratively and strategically with our leadership to drive a culture of ethics, integrity and compliance across the Loxo organization. This position will have the opportunity to partner with the corporate leadership team on both the strategic and operational direction of business, and provide guidance on opportunities and challenges that may be forecasted.

Our compliance function will be accountable for establishing, monitoring and continuously improving Loxo’s Compliance Program. This will include defining compliance standards via policies and procedures, compliance training and communications, auditing and monitoring, facilitating internal reporting, conducting compliance-related investigations, and informing Executive Leadership and the Board of Directors of compliance matters.

Roles and Responsibilities of the Position*

Evaluate and establish company policies, SOPs, guidelines, and associated internal communication and training plans related to key areas of risk relevant to global pharmaceutical companies.
Design and deliver compliance-related training, including new hire training, code of business conduct and ethics training, and policy-related training.
Design and manage the company’s compliance with state and federal aggregate spend reporting and disclosure laws requiring specific compliance program elements, including implementation of the appropriate systems.
Design and perform compliance monitoring activities to prevent, monitor and detect compliance-related issues.
Oversee company trading policy and administer trading review process.
Develop and execute risk assessments and reviews of compliance risk areas to determine need for improvement.
Counsel and provide leadership with business partners on compliance and compliance process issues.
Perform or collaborate in performing investigations of potential compliance issues.
Work closely with executive leadership to ensure appropriate risk management.
Oversee compliance hotline.
Periodically review and update the code of business conduct and ethics to ensure continuing relevance in providing guidance to management and employees.
Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications.

Required Qualifications and Background

Candidates should have strong academic credentials as well as 6 to 15 years of experience in a law or consulting firm setting advising or counseling pharma or biotech clients, or in an in-house pharma or biotech setting.
Knowledge of laws and regulations relating to prescription pharmaceuticals.
Outstanding written communication skills, with an ability to cogently and succinctly communicate complicated legal and compliance principles in a straightforward, understandable manner.
Strong presentation, influencing and collaboration skills.
Ability to communicate with all levels of management and employees, both in writing and verbally.
Possess sound, practical judgment in the interpretation and application of relevant laws, regulations, industry standards and company policies.
Excellent project management skills with the ability to organize and manage multiple priorities while meeting deadlines.
Self-motivated and able to work with minimal supervision; able to exercise sound judgment in resolving matters of high complexity and escalating matters appropriately.
Strong analytical and critical thinking as well as demonstrated accuracy and attention to detail.
Ability to handle multiple tasks in a fast-paced environment.
Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
Demonstrated strong commitment to and model of compliance, ethics and accountability.

Additional Preferred Qualifications

Experience drafting and implementing policies for a life sciences company.
Experience working across multiple countries.

Physical Demands / Travel

The demands of this position are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee performing the essential functions of this job.

Apply Now

Head of Drug Safety

Location:

Stamford, CT

Reports To:

TBD

Position Summary

The Head of Drug Safety is responsible for managing the safety surveillance program for investigational and post marketed products. The Head of Drug Safety is responsible for managing technical functions at a strategic level, playing a major role in shaping cohesive pharmacovigilance strategies through effective optimization and integration of operational and safety systems functions. This individual is responsible for the maintenance of structural organization within the department, as well as the technical and managerial coordination of its groups and staff.

Roles and Responsibilities of the Position*

Ensures standard processes and procedures for all aspects of pharmacovigilance including adverse event case handling, aggregate reporting and ensuring compliance with global and local regulatory requirements.
Demonstrates and applies advanced knowledge of safety concepts, per ICH, US and international guidelines and Good Pharmacovigilance Practice (GPvP).
Collaborates with safety systems associates ensuring Argus support of safety reporting, audits and inspections, aggregate reports, and signal detection.
Collaborates with internal and external stakeholders, including: Medical Affairs, Clinical, Regulatory, Quality Assurance, Marketing Partners, and CROs.
Responsible for the oversight of SOPs development and management plans/procedures needed for the Safety Group to execute its responsibilities.
Accountable for effective management of departmental resources, expenses and budget.
Supervises Operational and Safely Systems Personnel in the Drug Safety Department.
Provides expert pharmacovigilance guidance and leadership both internally and externally.
Responsible for oversight of quality, standards and training of personnel.
Responds appropriately to rapidly changing safety regulatory environment with minimal oversight.
Responsible for the oversight of regulatory queries concerning adverse event documentation.
Creates a talent management plan to address individual performance needs as well as establishes a succession plan for the team.
Ensures effective performance management process is in place and specific development plans implemented for each team member.

Required Qualifications and Background

M.D. or Doctorate level degree in health sciences is required.
Clinical experience as a Pharm.D. or M.D. required, including significant pharmaceutical industry safety surveillance with clinical expertise in Oncology.
Minimum of seven to ten years of progressive experience in Drug Safety in a biotechnology or pharmaceutical company required.
Prior experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance required.
Advanced knowledge of safety concepts, per ICH, US and international guidelines and Good Pharmacovigilance Practice (GPvP) required.
Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
Expertise in the use of MedDRA is required.
Strong operational skills as demonstrated by leading previous projects or functions and or equivalent in training and education in areas such as Lean Six Sigma or MBA preferred.
Must possess strong ability to communicate and integrate their work activities with co-workers, and to effectively organize and present ideas and results.
Must be proficient in MS Office Suite.
Expert knowledge of relational database applications (including Argus or other safety database).
Solid knowledge of safely database operations and functions.
Strong ability to prioritize tasks and keen attention to detail.
Excellent writing, communication, presentation, and interpersonal skills.
Demonstrated leadership and project management skills.
Ability to be both enterprising and resourceful.
Proven ability to work on multiple projects in a fast-paced environment.

Physical Demands / Travel

The physical demands of this position are consistent with light office duties. The role may require up to 15% domestic and international travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

Apply Now