Senior Manager/Associate Director, Medical Information, Medical Affairs
Deciphera Pharmaceuticals
 Waltham, MA
Company Summary:
Deciphera Pharmaceuticals
is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.

We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
·       providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
·       a diverse and multi-disciplinary workforce
·       dedicated and talented people who are passionate about achieving excellence in all they do
·       a work environment that allows you to balance your priorities
·       above all else, a commitment to the patients we serve

Deciphera Pharmaceuticals is searching for a highly motivated, insightful, and resourceful individual to join the newly formed Medical Affairs team.

Reporting directly to the Global Medical Affairs Excellence Director, this highly visible role will have the rare opportunity to help build the Medical Affairs function from the ground up as we prepare to launch Deciphera’s first commercial therapy.

The Senior Manager/Associate Director, Medical Information, Medical Affairs will sustain and promote Deciphera's professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by delivering high quality responses to unsolicited requests for information. The Senior Manager/Associate Director, Medical Affairs is responsible for providing accurate, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally.

This role is also responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and patient outcomes associated with assigned Deciphera products and disease states. As necessary, this individual may support broader activities within Medical Affairs. The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.

Key Responsibilities

  • Develops and maintains current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Deciphera products and disease states.
  • Delivers high-quality, balanced and timely written or verbal medical and scientific information upon the request of health care professionals and consumers.
  • Researches the appropriate sources of data/information to provide a quick, accurate and thorough response.
  • Leads the development (research, outline, compose, review) and maintenance of standard and custom medical information responses in various formats to address vast array of inquiries.
  • Assists in the review, fact-checking of data points, assessment of appropriateness of references cited in materials submitted to the Promotional and Medical Review Committees
  • May represent Medical comments in the Promotional and Medical Review Committees
  • Provides direction to third party contact center as it relates to: Compliance with workflow procedures and standards; Inquiries requiring escalation or customization; Corrections resulting from quality control / case review activities; New hire or ongoing therapeutic area/product training, as applicable.
  • Proactively distributes important product and / or medical information to internal stakeholders as necessary in support of product changes, safety issues and other sentinel events. 
  • Supports Deciphera’s medical information booth activities both during preparation for and during professional scientific meetings / medical congresses.
  • Supports the generation of therapeutic area metrics and analytics; maintains in-depth understanding of historic trends and insights of inquiries received.
  • Maintains up-to-date medical information and knowledge management systems / repositories.
  • Understands and effectively applies and complies with appropriate ethical, legal and regulatory standards, including those for responding to unsolicited requests for information, on / off label inquiries, and product promotion.
  • Assists in the development and delivery of various presentations to internal colleagues (e.g., medical information inquiry metrics and customer insights; training of commercial and medical field teams on medical information procedures; medical booth training at medical congresses) 
  • As applicable, reports any product quality complaints and adverse events to Quality Assurance / Drug Safety per corporate policies.
  • As applicable, supports various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; vendor oversight; etc.
  • As applicable, provides support to broader activities in Medical Affairs. 

Required Qualifications

  • Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) required with 3 years of medical information or medical communications experience in the pharmaceutical/biotech industry 
  • Demonstrated success in negotiating and influencing stakeholders
  • Understands drug development, US (FDA) and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints 
  • Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters and abstracts
  • Strong written and verbal communication skills 
  • Proficient in literature searching skills
  • Proficiency with Microsoft Office Suite 
  • Detail-oriented + Self-motivated to drive for results
  • Excellent organizational, time management and prioritization skills
  • Ability to travel to meetings / conferences (domestic and international) approximately 20% of the time

Preferred Qualifications

  • Experience providing medical information/medical communication support within a Global function + 4+ years of medical information, medical review or medical communications experience in the pharmaceutical / biotech industry 
  • Completion of a post-PharmD Fellowship in the pharmaceutical/biotech industry 
  • Prior experience working with medical information systems/databases (e.g., IRMS) or promotional/medical review systems (e.g., Veeva PromoMats) 
  • Adept at learning new software / applications 
  • Training or past experience in assigned therapeutic area(s) or rare disease, hematology, oncology therapies
  • Experience working on product launches