Medical Safety Director MD
Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 8, 2021
Portfolio Safety Scientists (PCS-Sci) provide safety science and
pharmacovigilance support to molecules across the Roche portfolio.
As a group, they are responsible for all aspects of safety
science/pharmacovigilance, with accountability being held by PCS
leadership or SSLs (Safety Strategy Program Leaders) depending on
The Portfolio Safety Scientists (PCS-Sci) supports early and
late phase development activities as a member of the safety team,
providing essential safety oversight and input into all aspects of
study management across the entire development and marketed
portfolio. In the post-market setting this may include signal
evaluation, safety related activities associated with new drug
applications/regulatory filings, benefit-risk assessment and safety
The Medical Safety Director is recognized to have strong
expertise in drug safety and will be expected to work with minimal
oversight and apply strong self-leadership. They will bring safety
expertise to interactions with internal stakeholders, Regulatory
Authorities and Data Monitoring Committees and must have the
ability to interact effectively in a multifunctional and
multicultural team setting. The job holder will be expected to
identify areas of development and complete the required
They may be assigned the role of "Safety Program Strategy Leader
(SSL)" for one or more molecules. The SSL is the lead safety
accountable for the molecule safety strategy.
Under the matrix leadership of the SSL and/or in collaboration
with PCS colleagues
- Develop and maintain an expert understanding of the safety
profile of the assigned product(s) as well as understanding of the
relevant strategic context (e.g., disease under study, safety
profile of competitors, mechanism of action)
- Responsible for signal detection and management activities
including, but not limited to STAR maintenance, ISMP maintenance.
Contribute to the review of safety assessments and drug safety
reports for signals or issues (inc, product quality) or in response
to Regulatory Authority requests
- Provide expert contribution to the development of the product
- Take independent responsibility for risk management activities
including preparation and maintenance of CCDS, labeling document
maintenance (including IB), risk communications, RMP, REMS
- Review of clinical protocols, study reports, Investigator's
Brochure (IB), informed consent form (ICF) and other related
documents to ensure alignment with the safety strategy and ensure
the appropriateness of risk management strategies and risk
- Take responsibility for safety science contributions to
regulatory authority submissions (Investigational New Drug/IND
applications, New Drug Applications/NDAs, Marketing Authorization
Applications/MAAs, Variations, Renewals, etc.)
- Responsible for the preparation and maintenance of safety
sections of the Company Core Data Sheet and/or Reference Safety
Information in the IB
- Participate in and provide input for Drug Monitoring Committees
(iDMC) or internal monitoring committee (IMC) meetings, as
- In partnership with the SSL, support presentation of important
safety issues to the Drug Safety Committee (DSC), Development
Review Committee (DRC) and other internal and external review and
governance committees as needed.
- May be expected to support non-molecule projects, due diligence
evaluations and other projects as needed.
- Perform specialized roles with PSS. These may include, but are
not limited to; functional business process owner, subject matter
expert, safety committee member.
- Responsible for coordination and collaboration with vendors
servicing Safety Science
Additional responsibilities, under the delegated accountability
of the SSL
- Contribute and/or lead the development of the safety components
of the Target Product Profile (TPP), key claims and other lifecycle
strategic planning documents (e.g., IDCP, CDP)
- Accountable for the safety components of study reports,
aggregate reports and high level regulatory documents
- Acquire and contribute knowledge of relevant drug class and/or
competitor safety issues. Lead development of the safety
surveillance strategy, identify potential clinical safety issues
and recommend appropriate safety monitoring measures
- Lead the development of scientific publications (abstracts,
posters, papers) for scientific meetings/journals and approve the
submissions from a safety perspective
- Enable/facilitate the transition of appropriate drug candidates
from EMS to LMMS
Responsibilities due to medical qualifications
The MSD will provide clinical medical expertise and
decision-making, in areas where this is specifically required to
support colleagues in PCS. Situations where qualified clinical
medical input may typically be sought could include, but are not
- Acting in a formal capacity as the assigned medically-qualified
approver/signatory for any relevant safety-related documents where
there may be a regulatory and/or legal requirement for an
assessment or approval to be provided by a person who holds formal
medical qualifications in a given area of clinical practice, or in
a given territory.
- Interpretation of emerging safety-relevant data, in the context
of experience gained whilst practicing in relevant areas of
- Defining types of safety question or safety issue, in the
context of a molecule/program, that may require specific clinical
medical safety assessments or decisions to be made.
- Performing medical practice impact assessments in the context
of product quality safety issues (e.g. as part of defined
activities outlined in PT-managed processes that require formal
assessment by medically qualified individuals).
- Determining the potential clinical medical impact of
non-clinical safety findings, and/or the interpretation of
potential product risks associated with such findings, in the
context of current external clinical practice.
- Providing advice and interpretation of whether/how risks may
impact the overall clinical risk-benefit balance of an asset, in
the context of typical clinical medical practice in the
territories/countries where the product/asset will be used.
- Making formal company medical assessments that may be required
from PDS, with regard to the suspected causal relationship between
reported events and treatment. For example, where this is required
in the context of the management of Individual Case Safety Reports
(ICSRs) requiring assessment.
- Review of clinical study development plans and/or study
protocols (and other relevant clinical trial documentation), to
ensure their design is appropriate to current clinical medical
practice. In addition, to ensure that the measures outlined in
plans/protocols to manage defined patient risks, are
appropriate/feasible to implement in the context of current
clinical medical practice, and can reasonably be expected to
achieve the clinical risk management aims that have been described
in relevant risk management plans.
Behaviours and responsibilities
- Demonstrates behaviors consistent with Roche values and
engenders confidence from senior management
- Actively emulate and role model the Roche values, culture
(mindset and behavior), Roche core competencies and PD/PDS strategy
and drive for similar performance across relevant team
- Understands how safety activities contribute to company
development and commercialization goals and takes measures to
maximize safety value to the organization
- Demonstrates independence and high competence in the conduct of
all safety science responsibilities
- Establish and maintain collaborative working relationships with
all key stakeholders, and internal and external customers and
ensure the same across relevant teams
- Consistently comply with all governing laws, regulations, QMS,
Roche standard operating procedures (SOPs) and other
- Develop and maintain knowledge of the pharmaceutical industry
and drug development, including a comprehensive knowledge of
pharmacovigilance activities and requirements
- Acts independently and with minimal supervision to manage
safety responsibilities on study teams and in activities supporting
- Trains and mentors more junior PCS scientists
- Proactively takes on responsibility for complex
- Takes on team leadership responsibility in order to manage and
complete medium and high priority projects
- Seen by peers and cross-functional colleagues as an expert in
many safety science activities
- Contributes to embedding the agreed organizational models, and
the necessary mindsets.
- Leading self and others, often influencing without authority,
to deliver outcomes.
- Brings critical, systematic thinking to shape current issues
and opportunities into meaningful, deliverable actions.
- Willing to challenge embedded behaviors/mindsets, in order to
bring new and agile approaches to ways of working, and/or to
improve quality and efficiency.
- Holds themselves and peers accountable for their behaviours and
Education, Skills and Experience
They must hold a formal medical qualifications (e.g. MD; MB BS;
MB ChB) and have post-graduate experience in one or more areas of
clinical medical practice including in medical
specialties/disciplines that are relevant to clinical safety and/or
to the therapy/disease areas in which the company develops and
They will preferably hold relevant Board Certification(s) or be
board eligible, and/or other relevant post-graduate medical
qualifications, in relevant areas of clinical medicine.
They will preferably have experience in clinical medical
practice and will typically possess 6 or more years of clinical
drug development experience in the biopharmaceutical industry or a
related sector (e.g. academia; CRO; etc). Preferably including at
least 3 years of experience in a clinical drug safety-related
- The ability to demonstrate a broad understanding of the
scientific aspects of safety, PV and clinical/patient risk
management (e.g. via demonstrable knowledge of the application of
GVP, GCP & CTR requirements) is essential.
- Demonstrated ability to lead and influence, with and without
authority, in a global matrix environment.
- Excellent written and verbal communication skills.
- Proven success in creating and sustaining strong relationships
with internal and external business partners across an organization
to create positive partnerships.
- Evidence of proactive, structured thinking with the ability to
rapidly respond to an evolving and complex environment.
- Apply complex data analysis / statistical methods to evaluate,
interpret and present scientific data with clarity
- Strong presentation skills, effective at summarizing and
presenting the key considerations and decision points
- Ability to effectively train others on departmental practices
- (For roles in China) Fluent in Mandarin and English
Keywords: Hoffmann-La Roche Ltd, South San Francisco , Medical Safety Director MD, Other , South San Francisco, California
Didn't find what you're looking for? Search again!