Medical Manager, Early Pipeline

Job description

  Job facts

Job Title: Medical Manager, Early Pipeline (Neuroscience, Immunology, Ophthalmology)

Division: Medical & Regulatory Affairs

Department: Medical Strategy

Duration: 2 Full-Time Permanent + 1 one-year contract

Job Purpose:

As part of the Integrated strategy team, this Medical Manager will lead the medical strategic planning for early pipeline NMEs, establish strategic research partnerships & be the medical interface for early pipeline for new therapeutic areas for Roche. The focus of this role will be to:

·  Drive strategic initiatives in the early pipeline to meet the needs of patients, investigators and the broader medical health care ecosystem
·  Lead the medical strategic planning for early NMEs in close collaboration with Commercial and Clinical and bring scientific value to our investigators and the medical community by sharing insights that will help shape medical strategy for new therapeutic areas to Roche

Accountabilities:

1: Overall accountability for the medical strategic and tactical plan for MSLS

·  Identifies the healthcare professional and patient needs in assigned disease area(s) and characterizes implications to medical strategy
·  Identifies and prioritizes local medical gaps/hurdles
·  Identifies strategic opportunities and synergies across therapeutic areas, where applicable
·  Defines and prioritizes local medical strategies, including scenario and contingency plans
·  Aligns medical strategic plan with other functions' strategic plans (e.g. access, global, etc)
·  Defines local medical tactical plan and MSL POA (including an appropriate mix of insight generation, knowledge exchange, evidence generation, and internal expertise, according to life cycle)
·  Drive the execution of medical tactical plans through leadership of cross-functional medical team
·  Monitors execution of tactical plan and MSL POA against defined KPIs
·  Consistently evaluates, evolves and adapts medical plans as appropriate
·  Lead/participate as a member of local integrated cross functional teams and core medical teams
·  Participate & contribute to medical strategy within global and regional medical teams, where applicable
·  Provides MSL resourcing inputs based on the MSL tactical plan to inform field medical resource planning

2. Medical Science & Therapeutic Area Expert for Internal and External Stakeholders

·  Acts as a disease area expert (including: Roche products, competitors/other treatments, diagnostics) for:
·  internal Roche cross-functional stakeholders
·  diverse external stakeholders (e.g. HCPs, patients, payers, regulators, etc as required)
·  Leads scientific components of cross-functional projects and initiatives (e.g. clinical summaries for market access or Canadian therapeutic landscape overviews for regulatory bodies as required)
·  Acts and is regarded as a medical and scientific expert for assigned disease area(s) by external HCP peers
·  Stays up to date with scientific, medical, and technical advances in assigned disease area(s)
·  Translates scientific data into relevant insights - Draw appropriate conclusions of relevancy and understand implications

3. Evidence Generation Activities

·  Leads the development of evidence generation (EG) plan across the lifecycle of assigned therapeutic area(s)/product(s) through the identification and prioritization of the local evidence needs and gaps to determine the most effective EG strategies in collaboration with the EG team
·  Provide strategic input into the affiliate research portfolio by strategizing an optimal integration of phase III/IV clinical studies (in collaboration with Country Clinical Operations), investigator-initiated studies, real-world data studies, and innovative evidence solutions
·  Provide information and insights about global studies and relevant new products/indications to other local affiliate functions
·  Participate in clinical study design and execution (incl. liaising with scientific study groups for supported studies)
·  Builds external stakeholders collaboration and academic network (i.e. collaborative groups and academic organizations)
·  Understands and applies principles of statistics to data analysis
·  Ensures appropriate disclosure/transparency related to evidence generation and study conduct according to SOPs and GCP.

4. Scientific Communications

·  Accountable for all insight gathering activities performed to inform medical strategy. Gathers insights from multiple stakeholders. Leads the development of insight gathering projects for

MSL

·  Accountable for the finalization of all insight gathering reports which includes an accurate analysis of these insights. Proactively shares relevant insights with Global and local internal stakeholders as appropriate,
·  Leads the process to identify and profile HCPs to inform medical HCP tiering to finalize TAE lists for all medical activities for their therapeutic area:
·  Lead the process of obtaining relevant advice for external stakeholders through advisory boards or MSL advice seeking and analyses and puts into action the recommendations
·  Integrates and applies insights from multiple experts/stakeholders to support the development of the medical strategy
·  Accountable for the development of the local scientific communications strategy which applies tailored approaches aligned with life cycle of brand/therapeutic area
·  Accountable for the content of all medical communications materials for their therapeutic area
·  Accountable for the medical review of non-promotional material
·  Accountable for publication strategy for assigned therapeutic area(s) and manages integrated scientific communications plan
·  Accountable to ensure the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes
·  Respond to unsolicited questions from HCPs in accordance to local laws, regulations and codes and Roche/GNE SOPs, facilitate their needs of up to date scientific data, including but not limited to publications of clinical trials, guidelines, by ensuring they have the best quality available information they require

5. Budget and Vendor Management

Budget Management

·  Accountable for annual planning, phasing and continuous monthly monitoring/reporting of the medical budget (including Phase IV). This involves managing and reporting on several cost elements as well as managing changes and identifying the need for action for activities in scope
·  Demonstrates and applies a good understanding of the Roche accounting principles, financial reporting systems, budgeting process and cycles
·  Maximizes utilization of budget/resources through prioritization of multiple activities
·  Identifies opportunities for cross-functional cooperation to maximize utilization of resources

Vendor Management

·  Ensures appropriate oversight of all aspects of vendor activities to ensure highest standards of delivery
·  Negotiates with vendors and perseveres when facing challenges
·  Optimizes business impact related to services provided by vendors
·  Follows all processes as per local procurement guidelines on selection, qualification and oversight

Qualifications:

• Minimum of Master's Degree with a Science background or extensive therapeutic experience

• Extensive therapeutic experience preferred but not required

• Minimum of 3 to 5 years of experience with knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations

• Experience in development and implementation of clinical trials

• Experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Experience in writing clinical publications and delivery of scientific presentations

• Relationships with external KOLs, other thought leaders, and external organizations is strongly preferred

• Strong communication, interpersonal and networking skills

• Exceptional negotiation skills, presentation skills and analytical Skills

• Results oriented

• ICH, GCP and local regulations

• Appreciates the diversity of working with multi-function teams

• Knowledge of drug discovery & commercialization processes.

• MS office literate

• Fluent English language knowledge, written and verbal

Qualified candidates are encouraged to submit a cover letter and resume by: June 7th 2019.

This position is not car eligible.

This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.

NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.