Senior Medical Director, Product Development, Cardiovascular - Boston, MA, United States - Genentech

Description

The PositionRoche's Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.

Due to new projects in the cardiovascular therapeutic area, Roche is seeking an experienced cardiovascular drug developer to join the Nephrology, Rheumatology, and Cardiovascular late stage product development group.

This position will have the opportunity to drive and contribute to the overall direction for the cardiovascular therapeutic area, including interactions with research and early development.

The Senior Medical Director leads development of the Clinical Development (CD) strategy and plan and is responsible for ensuring effective and efficient execution for the assigned molecule(s)/indication(s).

Senior Medical Clinical Directors may have direct reports.

Senior Medical Directors are expected to demonstrate mastery of the core Medical Clinical Director role, perform their responsibilities mostly independently, and effectively lead multiple projects.

EXPERIENCE AND QUALIFICATIONS:

Academic/Scientific/Clinical:
M.D. or M.B.B.S.

Required; Board Certified CardiologistRelevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required6 or more years pharma/biotech experience; minimum of 3 years industry clinical development experience is strongly preferred.

Academic/teaching background is a plusExtensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance Experience publishing results of a clinical trial in a peer-reviewed journal is requiredExtensive pharma/biotech industry experience Extensive experience designing and conducting clinical trials (i.e. multiple trials)

Experience authoring a global clinical development plan is requiredAdvanced understanding of Phase II – III drug development Knowledge and understanding of Phase I & IV drug development is preferredComprehensive understanding of product and safety profilesExperience designing and leading cardiovascular outcome studies is highly preferredRegulatory:

Advanced understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is required.

Experience leading a HA interaction and submitting an NDA/BLA/MAA to HAs in the US and/or Europe is preferred.

Prior people management experience is preferredUp to 30% global travelKey Skills and BehaviorsEthics:
Has impeccable ethics.

Demonstrates, or proven ability to demonstrate, Roche ValuesAttention to detail:
Outstanding attention to detailIs regarded as an expert in his/her field, is highly respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful resultsHas consistently excelled as a cross-functional project team leader

Business Acumen:
Has in-depth knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.

Leads development of disease strategies and plans Organization:

Can prioritize multiple tasks and goals on time, on target, and within budgetInterpersonal skills: Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Writing: Outstanding written communication skillsPresentation skills: Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points.

Confident and competent when interacting with others internally and externally:
stays focused and on-point, is able to raise problems or challenges in a productive and mature manner

Negotiation Skills:
Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results

Decision Making:
Proven track record of effective decision-making. Makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy.

Able to make trade-off decisions and determine priorities and goalsFinancial acumen: Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources.

Capable of understanding complex analyses and planning for product valuations and project budgetsMentoring:
Aptitude or proven ability to mentor colleagues and foster their successful career development


SPECIFIC DUTIES AND RESPONSIBILITIES:

CDP Strategy and PlanningLeads or delegates development and implementation of the CD plan for assigned molecule(s)/indication(s)Gathers and analyzes data and information necessary to create the CD plan Responsible and/or accountable to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs Works with and/or oversees other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD planStays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s) As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignmentCollaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.

Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance.

Includes reviewing and providing late stage input into Phase I and II protocols Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies, including providing CD input for MA study protocol development.

Consults to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s) Provides, clinical science input into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP) CDP ExecutionLeads or oversees others in design, development, and execution of clinical studiesCollaborates with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materialsMay guide and advise others in the identification and selection of appropriate external investigators and sitesLeads the development and implementation of communications strategies to support ongoing and concluded studies.

Includes investigator meetings and KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materialsAccountable and/or responsible to ensure investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study Responsible for development and delivery of key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities.

Includes presenting at advisory boards and other relevant external forums representing Roche Acts as CD lead or supervises development of study analytics and data management plansLeads or supervises ongoing reviews of medical/safety dataCollaborates with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve suchCollaborates with relevant team members to ensure timely, completion of interim study reportingCollaborates with relevant team members and clinical operations to close-out clinical studies, secure data and complete study reportingResponsible and/or accountable to ensure correct medical/scientific data interpretation for interim and final study reportingLeads ongoing data generation to address unmet medical needs and identify new or extended CD studies for the assigned program or other programs Accountable to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target Acts as a medical monitor for assigned studies or delegates this responsibility appropriatelyCross-Functional Team LeadershipParticipates in and/or leads the relevant Clinical Science Team (CST) Leads and/or represents CD in sub-teams (e.g.

Study Management Teams) relevant to assigned molecule(s)/indication(s) and is responsible for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution Accountable for training new CST members May also, as appropriate, support relevant sub-teams in assigning and training new team membersParticipates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources Where assigned/appointed, expected to represent CD on core teams, e.g., Lifecycle Team (LCT).

Ability to act as the Global Development Leader (GDL) as needed and may be considered for permanent GDL positions when appropriateRegulatory ActivitiesLeads development of briefing packages by providing clinical science information and input Leads development of responses to HA questions by providing clinical science information and input Leads health authority (HA) interactionsTakes a lead role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.

Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.

People ManagementAs needed or otherwise appropriate, assists with CD recruitment, training, and/or coaching of new or less experienced CD staff members Where applicable, manages direct reports and is, in such instances, accountable for hiring, training, developing and retaining talent on his/her staff.

Consistently complies with all governing employment laws, regulations and company People & Culture (HR) policies & procedures Local/Global CommunitiesServes a significant role in the local site community, promotes discussion in the community, Clinical science representative on site-wide initiatives.

Visible in the global PDC community, e.g. contributing to All Staff meetings/offsite meetingsDisease/Therapeutic AreaContributes clinical science input into the relevant therapeutic/disease area scientific strategy.

Helps research and other PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals.

As appropriate/needed, performs clinical assessments on relevant drug discovery projectsLocation:
Boston, MA (USA), San Francisco, CA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us.

Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Job SummaryJob number:

Date posted :
Profession: Research & DevelopmentEmployment type: Full time