PharmaEssentia
Senior Director, Medical Affairs
The Senior Director, Medical Affairs role will identify and integrate the unmet needs and perspectives of healthcare providers, payers, patients, and caregivers into product and franchise Medical Affairs strategies. You will be responsible for the strategic development and overall accountability and tactical execution of our flagship product ropeginterferon launch in polycythemia vera. You will collaborate cross-functionally as well as collaborate with external KOLs and decision-makers.
Key responsibilities include:
Lead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and execution
Develop, execute and collaborate a highly efficient, integrated US medical affairs / scientific strategy
Provide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategy
Scientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholders
Involvement in the planning, strategy, tactics, slide deck development, and training of the MSL team. Strong collaboration with the MSL director
Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle management
Provide relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Review and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and Commercial
Partner with stakeholders to develop and implement real world evidence generating strategies for assigned programs and provide subject matter expertise
Strategic Guidance / US PEC representation at corporate meetings & events
Launch Lead / MSL Lead
External Expert Engagement (Providers, Payers, Advocacy)
Support Clinical Development
Support identification and management of and build relationships with key stakeholders
Identify and review potential clinical study sites supporting Clinical Development in study-site engagement
The person :
Education : PhD or PharmD required; MD degree preferred
Qualifications and experience :
Minimum of 10 years of relevant working experience in the Pharmaceutical / Biotechnology industry
Minimum of 6 years of experience in Medical Affairs
Ability to articulate complex scientific and medical information in understandable business terms
Knowledgeable in regulatory guidelines and clinical terminology
Ability to work independently and with a team with strong writing, communication, and project management skills
Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource
Experience developing engagement and education tools
Clinical trial support experience
Travel required - up to 25%
Preferred requirements :
Experience in hematology / oncology and rare diseases
Benefits
Comprehensive medical coverage
Dental and vision coverage
Generous paid time-off
401(k) retirement plan with competitive company match
Medical & Dependent Care Flexible Spending Account
Up to $150 monthly cell phone reimbursement
Employee Assistance Program
Free parking
EEO Statement At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Key responsibilities include:
Lead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and execution
Develop, execute and collaborate a highly efficient, integrated US medical affairs / scientific strategy
Provide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategy
Scientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholders
Involvement in the planning, strategy, tactics, slide deck development, and training of the MSL team. Strong collaboration with the MSL director
Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle management
Provide relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Review and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and Commercial
Partner with stakeholders to develop and implement real world evidence generating strategies for assigned programs and provide subject matter expertise
Strategic Guidance / US PEC representation at corporate meetings & events
Launch Lead / MSL Lead
External Expert Engagement (Providers, Payers, Advocacy)
Support Clinical Development
Support identification and management of and build relationships with key stakeholders
Identify and review potential clinical study sites supporting Clinical Development in study-site engagement
The person :
Education : PhD or PharmD required; MD degree preferred
Qualifications and experience :
Minimum of 10 years of relevant working experience in the Pharmaceutical / Biotechnology industry
Minimum of 6 years of experience in Medical Affairs
Ability to articulate complex scientific and medical information in understandable business terms
Knowledgeable in regulatory guidelines and clinical terminology
Ability to work independently and with a team with strong writing, communication, and project management skills
Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource
Experience developing engagement and education tools
Clinical trial support experience
Travel required - up to 25%
Preferred requirements :
Experience in hematology / oncology and rare diseases
Benefits
Comprehensive medical coverage
Dental and vision coverage
Generous paid time-off
401(k) retirement plan with competitive company match
Medical & Dependent Care Flexible Spending Account
Up to $150 monthly cell phone reimbursement
Employee Assistance Program
Free parking
EEO Statement At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr