Director, Pharmacovigilance and Risk Management

Company: Deciphera Pharmaceuticals
Location: Waltham
Posted on: September 12, 2020

Job Description:

Director, Pharmacovigilance and Risk Management Waltham, MA /

Clinical Development & Operations – Clinical Development /

Deciphera Pharmaceuticals is a commercial biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates in clinical studies, QINLOCK is Deciphera’s first FDA-approved drug, a switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK, an oral oncolytic, is also approved in Canada and Australia for the treatment of fourth-line GIST.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

- Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.

- Accountability – for our performance and the way we work with coworkers and other stakeholders.

- Transparency – in our intent and actions to both internal and external stakeholders.

- Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.

- Stewardship – values and uses wisely the resources and investments provided to the company.

Our Science and Our Pipeline:

Deciphera is developing novel small molecule drug candidates to improve the lives of cancer patients by addressing key mechanisms of tumor and drug resistance that limit the effectiveness of many cancer therapies. Our pipeline of drug candidates is designed to stop cancers from growing and spreading by inhibiting mutant forms or over expression of a family of enzymes called kinase. Enabled by our proprietary kinase switch control inhibitor drug discovery platform, we have developed kinase switch control inhibitors that interact at a molecular level in a way that is distinct from other kinase inhibitors and are designed to generate higher and more durable rates of response.

We have developed a diverse pipeline of differentiated, wholly owned, orally administered, oncology drug candidates that includes, among others, our recently approved product, QINLOCK (ripretinib), a broad-spectrum KIT and PDGFRa kinase switch control inhibitor is approved for the treatment of fourth-line GIST. Our follow-on study of ripretinib, the INTRIGUE study, is a pivotal Phase 3 trial in second-line GIST. We also have two additional clinical-stage programs for drug candidates DCC-3014 and rebastinib, both immune-oncology (or immunokinase) inhibitors, targeting the kinases CSF1R and TIE2 respectively. Two research-stage programs are in the pipeline as well.

Position Summary:

The Director Pharmacovigilance and Risk Management serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for investigational and/or marketed product(s). The Director Pharmacovigilance and Risk Management is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Director Pharmacovigilance and Risk Management also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate.

The successful candidate will have demonstrated successful mastery of the above responsibilities in their work. Accountability and a sense of urgency in leading/managing projects is a key success factor for this role. Demonstrated ability to review and analyze clinical data, be able to make assessments and be able to communicate effectively both verbally and in writing.

Position will report to the Director/Senior Director of Pharmacovigilance

Key Responsibilities Serve as key analytic and safety support lead in close collaboration with the product safety physician/medical monitor

Responsible for signaling review and the coordination and documentation of all signal review activities with the product safety physician and product complaint staff. This includes performing signal investigations and drafting signal investigation reports.

Support submission activities related to safety and provide input/ review CTD modules e.g. 2.7.4, 2.5, integrated summary of safety (ISS)

Provide support in preparation of query responses from health authorities related to safety

Manage literature review plan for product(s)

Safety Committee preparation and documenting of meeting minutes

Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.

For investigational product(s): safety review of protocol and CRFs, safety content of IB, RSI, ICF, and as appropriate support DSMB activities. Assist with lab and AE data review, associated with clinical study reports.

Lead PBRER/PADER/DSUR strategy and timelines with key stakeholders and vendor.

Lead RMP strategy and support RMP updates and REMS reports as appropriate.

Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities.

Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.

Other tasks as assigned or required

Required Qualifications Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.

Advanced degree (PharmD, RN, MD, PhD, MPH, NP)

Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.

Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues

Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff.

Applies clinical judgment to interpret case information.

Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.

Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems

Keywords: Deciphera Pharmaceuticals, Waltham , Director, Pharmacovigilance and Risk Management, Other , Waltham, Massachusetts