Director, US Medical Affairs Strategy – Nephrology

located – Whippany, NJ

Responsibilities *****

 

• Active participation and effective interaction with Global teams to ensure appropriate US direction of the company’s research and marketing efforts relative to the US environment as well as responsible for the design, planning and execution of an overall medical strategy including creating, organizing and leading Advisory Boards.

• Provide support and medical expertise to US cross-functional teams within the Business Unit regarding development of educational materials, monitoring of published literature, addressing and resolving international, regional and local issues related to products under their responsibility and provide input to company documents to ensure scientific accuracy as well as implement the Medical Affairs Brand Plan, communication and publication programs with approved budgets

• Support completion of annual NDA reports for respective brands through evaluation of clinical data and literature and provide USMA input in the preparation of key medical documents for INDs and NDAs. This includes ensuring appropriate USMA input in interactions with the FDA and providing appropriate medical leadership for any interactions.

• Chairs the scientific review meetings of investigator initiated and Phase IV studies and be answerable medically for the clinical studies under their direction as well as directing the design, conduct, analysis and reporting of Phase IV US clinical trials. This also includes providing key strategic US input for clinical development plans (Phase I – IV) and reviewing and co-approving clinical study protocols.

• Participate in the Grant Review and Advisory Committees

• Explore and evaluate new product ideas to assist in identifying new marketing opportunities and perform medical evaluations and due diligence on pharmaceutical products for in-licensing in the US

• Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations in order to develop and maintain productive contacts

• Provide feedback with the respective line manager in the recruitment, development and performance management of appropriate team members (including cross-functional partners) as well as managing performance and development planning of all direct reports including adhesion to all training and compliance policies.

• Drives the medical affairs planning process with respect to educational goals, investigator sponsored trials, foundations, professional organizations and thought leader activities

• Will assess educational programming, ensuring that the educational needs of the healthcare professional are met through appropriate alignment with the strategy.

• Oversees the IST program and unsolicited grant request process to ensure alignment with the medical affairs strategies and gap analysis

• Manages CME partners to ensure that medical education activities are of the highest scientific rigor, educationally well designed and delivered in a timely, cost-efficient manner and in compliance with regulatory requirements

• Frontline interface with investigator sites for all ISS data per SOP in multiple specialized databases (IMPACT, dBox and STREAM) including study site information, study progress, manages payment milestones processing, and study medication shipment fulfillment.

• Develops monthly financial accruals and rolling forecasts; prepares and reports on ISS and Med Ed metrics for assigned TA(s).

• Incorporates medical brand plan in project management tool, assessing deadlines and budget. Allows for changes in course as the landscape changes, e.g. competition.

 

Requirements *****

 

• M.D. Degree or equivalent

• US Board certification and licensure (active) highly preferred.

• Preferred specialty training in nephrology or cardiology

 

• 5+ years of clinically relevant or independent research experience or equivalent OR 5+ years’ experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g., lead PI and consultant, FDA employee or advisor)

• Proven ability to identify and resolve complex problems

• A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics.

• Ability to collaborate with a variety of teams and personnel as well as a proven ability to interact effectively with key opinion leaders

• Highly developed ethics and integrity, with demonstrated ethical medical decision making skills

• Ability to work well on teams as well as ability to assume leadership of a team

• Strong negotiation and influencing skills

• Proven ability to implement successful clinical strategies and programs

• Effective communicator with strong oral and written communications skills

• Demonstrated success in leading both internal and cross functional project teams including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities.

• Proven ability to achieve timely approval of dossiers and regulatory submissions and to be able to develop highly successful clinical strategies and programs

• Candidate should have a thorough understanding of ACCME, PhRMA and OIG guidelines

• Knowledge of educational instructional design, needs assessments, outcomes assessment, and clinical trial design; scientific analytical skills

• The incumbent must be able to represent company when traveling to medical and scientific conferences. Must establish professional relationships with vendors, clinical investigators, opinion leaders, consultants, clinical research organizations, professional societies, etc.