Senior/Group Medical Director and Global Head of Product Dev
Company: Genentech
Location: San Francisco
Posted on: February 26, 2021
Job Description:
Senior/Group Medical Director and Global Head of Product
Development, Nephrology Roche's Clinical Development organization
is structured by therapeutic area and is responsible for developing
and executing the late development (Phase II - IIIA) clinical
strategies and plans that deliver medically-differentiated
therapies that provide meaningful improvement to patients. The PD
Group Medical Director leads and oversees one or more Clinical
Science Teams (CSTs) who are responsible for developing global
Clinical Development (CD) strategies and plans and ensuring
effective and efficient CD plan execution for one or more
molecules/indications. PD Group Medical Directors guide development
of and approve CD strategies, priorities, final interpretation and
completion of clinical study results. PD Group Medical Directors
interact with the highest levels of management and experts both
internally and externally; serving as an internal consultant to
Roche committees as well as representing the therapeutic area's CD
strategy, plans, objectives and interests to health authorities
(HAs) and prominent thought leaders. PD Group Medical Directors are
expected to provide critical insights and contributions to the
overall development and effectiveness of the assigned therapeutic
area(s), including therapeutic area scientific strategies and
plans. Cross-Functional Team Leadership
- Typically a standing member of the therapeutic area's CD
Leadership Team
- Leads one or more CSTs
- Represents CD for assigned portfolio at the highest
management/expert levels inside and outside Roche; includes
championing and sponsoring the work of his/her staff
- When assigned/appointed, acts as the Global Development Leader
(GDL). Where assigned/appointed, represents CD on core teams, e.g.,
Lifecycle Team (LCT)
- Oversees one or more CSTs for CD studies relevant to assigned
molecule(s)/indication(s) and guides direct reports to, in turn,
guide teams to ensure cross-functional integration, coordination
and alignment to enable effective and efficient CD plan
execution
- Ensures direct reports and their staff are actively and
appropriately aligning with sub-teams (e.g., Study Management
Teams), with which CSTs collaborate, to ensure on-time and
on-target results
- As needed, provides leadership guidance and direction in
ongoing enhancements/development of core and sub-team processes,
structures, systems, tools and other resources
- Works with manager and peers to identify and ensure the
appropriate infrastructure - clear roles and responsibilities,
learning and development, technology, other tools, vendor partners
and operating budgets
- Assigns direct reports their projects and programs and guides
direct reports in their assignment of projects and programs across
their staff
- Cascades strategic and other relevant goals and objectives as
well as expense budgets to direct reports
- Tracks departmental expenses budgets to ensure compliance with
agreed parameters
- Leads recruitment, hiring and training for his/her staff member
roles
- Provides direct reports with ongoing coaching, development and
leadership; includes holding regular staff and 1:1 meetings
- Oversees staff members' work to ensure on-time, on-target and
within-budget results
- Plays a leadership role in all formal and informal performance
management and career development activities for his/her staff
members
- Leads succession planning for key positions within his/her
staff; ensuring at all times a robust pipeline of talent to fill
future openings
- Actively participates in leadership and skill development
programs for continued professional development
- Initiates and develops cross-functional projects, programs or
other initiatives that can carry broad and important impact to
multiple Product Development objectives and activities
- Consistently complies with all governing employment laws,
regulations and company HR policies & procedures and ensures the
same across his/her staff Global Clinical Development Planning
- Stays 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). Ensures the same across his/her staff.
- Provides CD leadership guidance and direction regarding
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 assignment. Ensures the same across his/her staff
- Educates others internally and externally on relevant clinical
developments as these may implicate the assigned therapeutic area's
CD strategies, plans and programs
- --- Collaborates with a variety of internal and external
partners and stakeholders, such as HAs, clinical investigators,
clinicians, scientists and key opinion leaders (KOLs). Has
extensive interactions with these external parties, subject matter
experts and influencers. Supports his/her direct reports and/or
other CD staff members in their communications and interactions
with these external parties
- Works across Roche at all levels and with various groups and
functions, such as other groups in PD, research, business
development, manufacturing, commercial operations, legal, etc.;
providing ongoing leadership expertise and guidance on the assigned
therapeutic area's clinical strategy
- Plays a leadership role in providing clinical science input
into the relevant therapeutic 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 or delegates
clinical assessments on relevant drug discovery projects
- As needed, ensures his/her staff members support internal
partners in transitioning new drugs/indications into Phase IIIB or
publication studies. Expected to provide expert leadership CD
guidance, when needed, on Phase IIIB protocols
- Consults to, and/or assigns staff members to consult to, pharma
partnering on relevant acquisitions, joint ventures or other
strategic partnerships, as these potentially relate to the assigned
therapeutic/disease area(s). Serves on joint executive committees,
which include other Roche functions as well as external partner
personnel, and/or assigns such responsibilities to direct
reports
- Leads global CD strategy development for the assigned
portfolio. Acts as a regular reviewer/presenter to various internal
committees
- Acts as an expert advisor and consultant to various internal
committees, other Roche management and teams regarding CD
strategies, priorities, implementation and the like
- Leads global development of clinical science input into annual
and strategic Lifecycle Plans (LCPs) and the Integrated Development
Commercialization Plan (IDCP). Acts as an expert advisor to others
regarding CD strategic alignment with and implications for LCPs for
the assigned portfolio
- Oversees creation and implementation of global CD plans for all
molecule(s)/indication(s) and/or other programs across the assigned
portfolio:
- Accountable to ensure strategic and operational alignment of CD
plans with the relevant CD strategy, strategic and annual LCPs
- Guides CSTs in developing all CD plan components (e.g.,
analytics/data strategy, KOL development, publications strategy,
etc.)
- Reviews budget and other resource requirements necessary to
implement and execute CD plans. Provides leadership guidance and
direction to ensure the most appropriate and optimal use of
resources
- Supports direct reports, as needed, to ensure they gain
alignment with various internal partners/stakeholders on goals and
resource needs. Includes guiding direct reports and other team
leads
- As needed, or otherwise appropriate, supports direct reports
and/or other team members in their communications with HAs.
Accountable to ensure his/her team members ethically, effectively
and professionally represent the interests of Roche and patients.
Accountable to ensure matters are escalated, when needed, in a
timely manner to appropriate internal partners/stakeholders Global
Clinical Plan Development Implementation
- Accountable for the design, execution and medical/scientific
data interpretation of global clinical studies and programs across
the assigned portfolio:
- Manages across multiple, often large-scale and highly complex
projects
- Provides guidance to direct reports in the strategy, design and
implementation of clinical studies and other programs
- Reviews various items and activities and provides leadership
guidance and direction to ensure successful execution and
completion of clinical studies and other programs: study protocols,
incorporation of crossfunctional strategies and input into
programs, product safety profiles, etc.
- Oversees development of clinical sections of investigator
brochures, other external presentations, information and
materials
- As needed, guides others in the identification and selection of
appropriate external investigators and sites
- Guides others in patient registry design and development
(including strategies for patient registry recruitment)
- Advises direct reports and others on development of study
analytics and data management plans for their key, large-scale
studies
- Reviews and approves clinical components of presentations for
clinical trial investigator and other relevant meetings
- As needed, supports direct reports in conducting investigator
or other external presentations, meetings and other
communications
- Provides ongoing guidance to direct reports, cross-functional
teams, internal committees and company executives regarding the
overall strategy, implementation and prioritization of CD
activities across the assigned portfolio
- Regularly reviews medical/safety data
- Measures and monitors study progress against objectives and
plans, including any variances. Proactively guides other team
members on identifying, communicating and addressing any issues,
challenges and potential strategies to resolve such
- Reviews and approves various interim study reporting prior to
further dissemination
- Serves as a resource for issue management and resolution.
Anticipates issues and helps prevent and/or resolve these
- Oversees clinical study, database and study reporting
completion. Approves final study reporting prior to further
dissemination
- Accountable to ensure correct medical/scientific data
interpretation for interim and final study reporting
- Guides direct reports in their assimilation and translation of
safety and efficacy data for regulatory submissions
- Oversees clinical science input for completion and submission
of regulatory filings and other regulatory documentation. Advises
direct reports and other team members in their development of
clinical science information and input into regulatory submissions
and other regulatory processes. Includes guiding others, as
necessary, on development of labeling and packaging language,
etc.
- Keeps partners and stakeholders abreast of developments
relative to the work of CD and the assigned portfolio and ensures
same approach is consistently taken across his/her staff
- As needed, advises direct reports and other team members
regarding communications strategies to support existing and
concluded studies. Includes KOL interactions, advisory boards,
major medical meetings, congresses and other events, publications
and other materials used to communicate Roche's clinical view and
position on clinical development plans and study results for
molecules/indications across the assigned portfolio
- Develops and delivers key presentations, both internally and
externally, to convey the CD perspective and provide updates on
strategies, plans and other activities. Includes regularly acting
as an expert participant and contributor on advisory boards and
other relevant external forums representing Roche
- Drives ongoing data generation. Plays a lead role within the
assigned therapeutic area(s) to identify significant opportunities
for unmet medical needs
- Accountable to ensure that CD plans, objectives, and
deliverables are consistently accomplished on-time and
on-target
- Leads other special projects. Expected to proactively identify
opportunities to continuously improve CD processes and operations
and Roche's leadership position in CD
- Consistently complies with, and ensures the same among relevant
CST members, all governing laws, regulations, Roche Standard
Operating Procedures (SOPs) and other guidelines SELECTION
CRITERIA: Candidates for this position should hold the following
qualifications, have the following experience, and be able to
demonstrate the following abilities to be considered as a suitable
applicant. Please note that except where specified as "preferred,"
or as a "plus," all points listed below are considered minimum
requirements. QUALIFICATIONS & EXPERIENCE:
- M.D. with relevant medical experience in same/similar
therapeutic area required
- 10 or more years pharma/biotech industry experience OR is a
recognized expert in the field. A minimum of 4 years industry
experience is preferred
- 4 or more years' experience managing medical/clinical
staff
- 8 or more years' experience with clinical trials
- 2 or more years' experience submitting NDAs/BLAs to regulatory
authorities in Europe and/or the U.S.
- 4 or more years' experience authoring global clinical
development plans
- 4 or more years' experience publishing results of clinical drug
trials in referred journals
- In-depth understanding of Phase I - IV drug development
Multidisciplinary experience in the pharma/biotech industry is
strongly preferred (e.g., research, regulatory, clinical
operations, business development, commercial operations, etc.)
- Strong academic/teaching background is strongly preferred
- Broad experience in the principles and techniques of data
analysis, interpretation and clinical relevance (e.g., ISS, ISE,
competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- In-depth knowledge of medical aspects of GCP (Good Clinical
Practice), ICH (International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use), FDA, EMEA, NICE and other relevant guidelines and
regulations
- In-depth understanding of competitive activity in the
field
- Current or past leadership roles in major scientific and
advocacy organizations and standard-setting bodies is preferred
ABILITIES:
- Has impeccable ethics. Demonstrates, or proven abilities to
demonstrate, Roche Values
- Clinical leadership: is recognized as a subject matter expert
in his/her field (includes external recognition as an expert); able
to evaluate, interpret and present highly complex data for a series
of studies (prospective and retrospective); has made significant
contributions to an organization's drug development (whether for
Roche or another organization); has identified and created clinical
development strategies that have led to label-enabling product
definitions
- Has demonstrated outstanding leadership of multiple development
projects and teams
- Proven abilities to plan and resource multiple development
projects on short-, medium- and longer-term bases
- Outstanding organizational and time management skills; proven
abilities to manage multiple, often complex and sometimes
competing, objectives, goals and other priorities to effective and
efficient conclusion
- Strategic agility: has in-depth knowledge and broad experience
in the pharma/biotech industry and is able to bring this to bear in
accomplishing strategic goals and objectives
- Outstanding judgment and decision-making skills; past results
are indicative of consistently sound and effective business
decisions
- Considerable comfort around all levels of management; has
regularly demonstrated the managerial courage necessary to succeed
at higher-levels within the organization
- Outstanding interpersonal skills; proven track record of
building strong and sustainable relationships with internal &
external partners/stakeholders
- Strong influencing skills; proven abilities to get things done
without formal authority
- Strong negotiation skills; is highly adept at identifying
solutions that will meet the needs of all parties involved
- Strong communication & presentation skills; exhibits
professional maturity, confidence and competence. Knows how to
summarize and communicate the key points and business case for
others to effectively and expeditiously make important business
decisions
- Strong conflict management skills; proactively minimizes
situations where conflict may arise
- Strong conflict resolution skills; proven abilities to
effectively and expeditiously reach satisfactory resolution among
all involved parties
- Outstanding financial acumen: has a proven track record of
achieving qualitative and quantitative results across multiple,
often large- scale and complex clinical development projects
- Ability to travel globally ( Who We Are Genentech, a member of
the Roche group and founder of the biotechnology industry, is
dedicated to pursuing groundbreaking science to discover and
develop medicines for people with serious and life-threatening
diseases. To solve the world's most complex health challenges, we
ask bigger questions that challenge our industry and the boundaries
of science to transform society. Our transformational discoveries
include the first targeted antibody for cancer and the first
medicine for primary progressive multiple sclerosis. Diversity and
Inclusion (D&I) are critical to the success of our company and
our impact on society. We believe that by championing diversity of
background, thought and experience, we can foster a sense of
belonging and provide an environment where every employee feels
valued, included, and able to contribute their best for the
patients we serve. We're focused on attracting, retaining,
developing and advancing our people to their full potential by
rewarding bold ways of thinking and integrating inclusive behaviors
into every aspect of our work. The next step is yours. To apply
today, click on the "Apply for this job" button. Genentech is an
equal opportunity employer & prohibits unlawful discrimination
based on race, color, religion, gender, sexual orientation, gender
identity/expression, national origin/ancestry, age, disability,
marital & veteran status. For more information about equal
employment opportunity, visit our Genentech Careers page .
Keywords: Genentech, San Francisco , Senior/Group Medical Director and Global Head of Product Dev, Executive , San Francisco, California
Didn't find what you're looking for? Search again!