The Role:
We are seeking a Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong pharmaceutical, clinical or scientific backgrounds who must have excellent communication skills. The MSL is responsible for identifying, developing, and managing relationships with current and future Healthcare Providers(HCPs) in academic and community practices.
This position is a remote, field-based position with significant travel required across assigned region.
What You’ll Do:
What You’ll Bring:
See more jobs at Deciphera Pharmaceuticals
Medical Science Liaison, Medical Solutions Lead, South Central Region
The Role:
We are seeking a senior level, experienced Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong clinical and/or scientific backgrounds who must have excellent communication skills. The MSL is responsible for identifying, developing, and managing relationships with current and future Healthcare Providers (HCPs) in academic and community practices. This person will have mentorship and oversight responsibilities within the MSL structure for an assigned portion of the U.S
This position is a remote, field-based position with significant in-person travel required across your assigned region, as well as ride-alongs with other US MSLs in their assigned regions. Role will also include virtual engagement with customers across the US
What You’ll Do:
In addition to the MSL responsibilities outlined above (~70% of role), this expanded role, who will serve as Medical Solutions Lead, will also have additional responsibilities, as designated and assigned by the Sr. Director, MSLs, which may include:
What You’ll Bring:
See more jobs at Deciphera Pharmaceuticals
The Role:
We are seeking a Medical Science Liaison (MSL), field-based scientific/clinical expert that will report to the Senior Director, MSLs within the Medical Affairs (MA) department. The MSL is a highly trained professional with strong pharmaceutical, clinical or scientific backgrounds who must have excellent communication skills. The MSL is responsible for identifying, developing, and managing relationships with current and future Healthcare Providers(HCPs) in academic and community practices.
This position is a remote, field-based position with significant travel required across assigned region.
What You’ll Do:
What You’ll Bring:
See more jobs at Deciphera Pharmaceuticals
The Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable).
What You’ll Do:
Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner
Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s). Review incoming adverse events to determine action required
Provide oversight and review of vendor case processing and submission activities by external vendor, including the review and monitoring of compliance through various monitoring reports and other oversight activities. Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database
Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor
Lead Deciphera Pharmaceuticals PV Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner. Manage SAE / SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements)
Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from Deciphera Pharmaceutical clinical trials
Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance to data requests. Performing and contributing to safety monitoring and signal detection activities for products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks. Perform ad hoc analyses as required
Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements
Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity. Communicates with partner companies and vendors regarding processing and timely exchange of safety data. Distributes aggregate reports as required and assists with reconciliation activities.
Develop and maintain Medical Safety and Pharmacovigilance related documents including Safety Management Plans, SOPs and Work Instructions, and Safety Data Exchange Agreements.
Lead preparation of safety-related plans with partners and CROs
Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Deciphera practices and procedures.
Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc.
Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed
Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities
Assist with the ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
Support the development of Deciphera Pharmaceutical PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
Adhere to company policies and applicable regulations including reporting of adverse events to regulatory agencies
Other duties as assigned
What You'll Bring:
Education: Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
6+ years of direct pharmacovigilance work experience in the pharmaceutical industry
Experience with Argus Safety database is a must
Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
ICSR submission experience is highly preferred
Knowledge of MedDRA and WHO Drug dictionaries
Experience with overseeing and managing vendors
Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data
Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. Must be able to work on multiple projects simultaneously
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
Proficient in standard computer software (Word, Excel and Power point presentations)
Previous experience and formal training with safety database programs including configuration and validation activities is
See more jobs at Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is seeking a Clinical Supply Chain (Senior) Manager to join our growing team. This individual will consistently demonstrate our PATHS Values and also manage day-to-day clinical supply chain activities to support Deciphera’s clinical programs. This involves translating clinical study information into a demand plan, managing clinical trial material inventory at third-party vendors, and maintaining essential documents. The Clinical Supply Chain (Senior) Manager serves as the primary supply chain lead for assigned clinical programs.
The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise. Strong cross-functional team leadership and project management skills are essential requirements.
This is an individual contributor role which will report to the Associate Director, Clinical Supply Chain, and be located in the Waltham, MA office or remote.
What You'll Do:
What You'll Bring:
See more jobs at Deciphera Pharmaceuticals
Associate Director, Market Access – International, France/Italy Cluster
The role of Associate Director Market Access – International is to develop and lead execution of Market Access Strategies for the defined scope of countries, in line with International Market Access Strategy for all current and future products that Deciphera plans to place in the market. As such, the main goal of this role is to secure and maintain patient access to existing and future Deciphera products in Europe focusing on France and Italy and potentially additional regional or international responsibilities.
The Associate Director Market Access International reports to the Head of Market Access International and works closely with Global, Regional and Local cross functional stakeholders (e.g.., medical, commercial, regulatory) to ensure successful implementation of the pricing & reimbursement processes in the individual countries as well as successful implementation of international market access strategy.
Key Responsibilities:
What You’ll Bring:
See more jobs at Deciphera Pharmaceuticals
Essential Duties and Responsibilities:
Deciphera is seeking a Director, Field Access (DFA) to join our US Market Access Team. The DFA is a strategic customer facing leader with the core responsibility to ensure coverage and create access for Deciphera’s oncology therapies with national and regional payer accounts, specialty pharmacies, specialty distributors, and oncology GPOs.
The DFA will develop and maintain key customer relationships, execute account plans for targeted national payers, an oncology GPO, and will coordinate case management with the sales team and internal partners. The DFA may serve as the primary point of contact for channel partners.
The DFA will collaborate with the patient support services center, Territory Managers, and Regional Business Directors to ensure minimal barriers to product access for patients and providers.
Key Responsibilities:
See more jobs at Deciphera Pharmaceuticals