Senior Medical Director, Disease Area Lead
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
The Disease Lead-Hematology will lead the Hematology therapeutic area Team within Medical Affairs team to develop and execute the US Medical Affairs strategy for Hematology at Pharmacyclics.
Key responsibilities Include :
Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Patients, Payer, Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safe guarding patient safety (risk minimization activities /safety surveillance activities).
Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical/marketing activities (e.g.), generation/product launches) and market access.
Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.
In cooperation with medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned product/projects.
Coordinates training in collaboration with Scientific Communications, identifies training needs through the Brand Teams, and clinical development strategic initiatives in the context of medical affairs.
Supervise employees either directly or in a matrixed environment depending on role and level of responsibility.
Establishes and approves scientific and medical imperative, initiatives and objectives that are in alignment with the overall strategic priorities for medical affairs.
Participation in design and execution of clinical trial safety, product safety and risk management plans.
May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to Pharmacyclics conduct on clinical studies.
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE's& SAE's) issues, interpretation of statistical analyses for clinical significance, Private Investigator selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of Clinical development teams.
Drives medical affairs activities (e.g. advisory boards, training, disease initiatives) and generation of data supporting overall product scientific and business strategy.
May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory) as they relate to on-going medical affairs projects.
Act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
Keeps a breast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource in Oncology.
Represents Pharmacyclics at external meetings including investigator meetings, scientific association meetings, Medical/Clinical Advisory Boards.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
Serves as the scientific team interface for key clinical, safety and regulatory discussions.
Represent the medical function to alliance partner in working groups and other cross-functional team meetings as needed.
May assist in developing/mentoring junior medical affairs staff.
Assists with the scientific review, development, approval, execution and communication of medical publications and review and approve investigator supported clinical research proposals.
Collaborate with Medical Publications Director to support the development of a medically sound publication strategy and plan.
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements, Ph.D. or Pharm.D.) with relevant therapeutic specialty (Hematology/Oncology) experience .
Typically 10+ years of medical affairs experience in the pharmaceutical or Biotech industry.
Proven leadership skills in a cross-functional global team environment.
Prior management experience preferred
Ability to run clinical studies or medical affairs team independently with little supervision.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, publication process/requirements and experience in development strategy and the design of protocols.
Expert knowledge in a relevant therapeutic specialty (Hematology/Oncology).
Ability to interact externally and internally to support business strategy.
Must possess excellent oral and written English communication skills.
Must have basic understanding of Pharmacovigilance practices for Clinical Development programs.
Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives.