Associate Director, Medical Affairs

Title: Associate Director, Medical Affairs
Location: Cambridge, MA (100% Remote)
Duration: 6 Months+ Possible Extension

Manager Notes:
Hybrid preferred. But remote candidates can also be considered.
If Hybrid, expected to visit the office at least twice a week. No specific days, depends upon the requirement.
High likelihood of further extensions beyond the given end date.

Summary & Purpose of the Position

• Reporting to the Senior Director, Medical Affairs (Adult Cholestatic Diseases), the Associate Director, Medical Affairs, will support and oversee select medical affairs activities related to biliary atresia.
• This role will contribute to the U.S. medical strategy for elafibranor and the broader Medical Affairs plan for cholestatic diseases. Responsibilities include medical review of non-promotional and promotional content, information responses (in collaboration with Medical Information), scientific communications including poster presentations and publications (in conjunction with the Publication/Medical Communications team), advisory board planning, the design and medical monitoring of US-based clinical studies, and the review and approval of educational grants.
• The Associate Director works with the MSL team in developing and managing regional relationships with Thought leaders (TLs).
• This role will also be responsible for assessing investigator-sponsored study (ISS) requests in collaboration with our local and global Medical teams.
• The candidate will work closely with the Global Training & Capabilities Excellence team to ensure we provide relevant internal training to our teams.
• The Associate Director will also work closely with the US and Global Medical Information teams to ensure Medical Information Response documents are accurate. Key internal partners include all sub-functions within Medical Affairs, commercial team, and global medical cholestatic disease personnel.

Main Responsibilities & Technical Competencies

• Contribute to develop and implement medical strategies that align with organizational goals and objectives.
• Serve as subject matter expert (SME) SME, on medical and/or disease area and asset cross-functional committees, as appropriate.
• Support clinical research projects, including the design, execution, and analysis of clinical trials.
• Contribute to the development of content for external medical education programs and take lead on presentations where applicable.
• Contribute to and lead advisory board planning and execution activities as assigned.
• As a SME, the candidate will be responsible to train internal Medical and cross-functional partners on disease area and client product content
• Review and approval of promotional and medical materials in PRC and MRC, respectively as needed.
• Provide medical input and oversee budgets for clinical grants and medical education support activities, in coordination with the Grants Manager.
• In collaboration with the Medical Communications Director, lead the development high-quality scientific and educational materials (e.g. MSL slide decks, FAQs, medical fact sheets, advisory board content, etc.)
• Contribute to the U.S. scientific publication plan
• Attend relevant congresses to engage in scientific exchange and provide congress coverage
• Support the planning, execution and budget oversight of medical activities for cholestatic diseases
• Excellent verbal and written communication skills to effectively convey complex medical information to diverse audiences.
• Project Management: Strong project management skills to oversee multiple projects simultaneously and ensure timely completion.

Knowledge & Experience:
Knowledge & Experience (essential):

• 5+ years experience in the pharmaceutical industry, primarily within Medical Affairs, with additional exposure to clinical trials and/or research experience is a plus.
• Ability to interact with cross-functional teams

Knowledge & Experience (preferred):

• Experience in Rare Disease or Liver/GI is preferred
• Launching new product/indication
• Experience in presenting and publishing scientific information.

Education / Certifications (essential):

• Advanced degree in a scientific discipline (MD, DO, PhD, or PharmD preferred)

Other Useful Information
Key internal stakeholders: Medical Affairs, Medical Information, GMA, Commercial Teams, etc.
Key external contacts: Thought Leaders (TLs), KOLs, scientific societies & congresses, etc.

Behavioural Competencies Required:

Communicates Effectively:
Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view
Communicates transparently, "tells it how it is" while keeping the communication respectful
Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
Demonstrates gravitas Clear, structured, and respectful communication is essential for medical review, scientific exchange, and internal training.

Business Insights:
Makes decisions based on data, facts, and figures, and considers different perspectives and the patients' voice
Able to translate to objectives and setting the bar Understanding the medical and commercial landscape is key to aligning strategies and making informed decisions.

Collaborates:
Collaborates and communicates without boundaries, continuously removes organizational barriers
Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset The role requires cross-functional collaboration with internal and global teams, including Medical Information, MSLs, and Commercial.

Manage Complexity:
Identifies contradictory information/demands/inputs to effectively solve problems
Develops and evaluates alternative scenario and solutions
Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact The role involves navigating complex medical data, regulatory requirements, and strategic priorities.

Ensures Accountability:
Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects)
Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others
Follows through on commitment and makes sure others do the same Accountability is vital for managing grants, clinical studies, and ensuring quality in medical materials and communications.
Communicates transparently, "tells it how it is" while keeping the communication respectful
Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
Demonstrates gravitas Clear, structured, and respectful communication is essential for medical review, scientific exchange, and internal training.

Business Insights:
Makes decisions based on data, facts, and figures, and considers different perspectives and the patients' voice
Able to translate to objectives and setting the bar Understanding the medical and commercial landscape is key to aligning strategies and making informed decisions.

Collaborates:
Collaborates and communicates without boundaries, continuously removes organizational barriers
Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset The role requires cross-functional collaboration with internal and global teams, including Medical Information, MSLs, and Commercial.

Manage Complexity:
Identifies contradictory information/demands/inputs to effectively solve problems
Develops and evaluates alternative scenario and solutions
Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact The role involves navigating complex medical data, regulatory requirements, and strategic priorities.

Ensures Accountability:
Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects)
Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others
Follows through on commitment and makes sure others do the same Accountability is vital for managing grants, clinical studies, and ensuring quality in medical materials and communications.
Communicates transparently, "tells it how it is" while keeping the communication respectful
Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
Demonstrates gravitas Clear, structured, and respectful communication is essential for medical review, scientific exchange, and internal training

Business Insights:
Makes decisions based on data, facts, and figures, and considers different perspectives and the patients' voice
Able to translate to objectives and setting the bar Understanding the medical and commercial landscape is key to aligning strategies and making informed decisions.

Collaborates:
Collaborates and communicates without boundaries, continuously removes organizational barriers
Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset The role requires cross-functional collaboration with internal and global teams, including Medical Information, MSLs, and Commercial.

Manage Complexity:
Identifies contradictory information/demands/inputs to effectively solve problems
Develops and evaluates alternative scenario and solutions
Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact The role involves navigating complex medical data, regulatory requirements, and strategic priorities.

Ensures Accountability:
Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects)
Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others
Follows through on commitment and makes sure others do the same Accountability is vital for managing grants, clinical studies, and ensuring quality in medical materials and communications.